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54 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Cosela (trilaciclib) / Pharmacosmos
NCT05071703: Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Completed
4
30
RoW
Trilaciclib, Trilaciclib, carboplatin, etoposide#or Topotecan
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
04/22
11/22
ChiCTR2300075388: Clinical study of trilaciclib for the prevention of severe myelosuppression after chemotherapy in patients with bone and soft tissue sarcoma

Recruiting
4
550
 
Patients with bone and soft tissue sarcoma who had IV-degree bone marrow suppression in previous chemotherapy did not receive Turacilli for preventive treatment.; Patients with bone and soft tissue sarcoma who have experienced IV-degree bone marrow inhibition in chemotherapy should receive trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) before the next chemotherapy.; Patients with bone and soft tissue sarcoma will not receive prophylactic treatment until they plan to receive a high-risk chemotherapy regimen.; Before patients with bone and soft tissue sarcoma are proposed to receive high-FN-risk chemotherapy, trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) for preventive treatment.
Affiliated Sixth People's Hospital, Shanghai Jiaotong University; Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Self-financed
Bone and soft tissue sarcoma
 
 
ChiCTR2300073043: Study on the preventive effect of Cosela on chemotherapy induced bone marrow suppression in patients with advanced gastric cancer receiving systemic treatment

Recruiting
4
200
 
Systemic chemotherapy with Cosela ;Systemic chemotherapy
The First Affiliated Hospital of Air Force Military Medical University; The First Affiliated Hospital of Air Force Military Medical University, Sponsored by Simcere Pharmaceutical
gastric cancer
 
 
Multiple Cohort Exploration of Trilaciclib in First-Line Combination Chemotherapy for Advanced Solid Tumors, ChiCTR2400082382: A Multi-Cohort, Open-Label, Exploratory Clinical Study of Trilaciclib in Myeloprotection in First-Line Combination Chemotherapy Regimens for Advanced Solid Tumors

Recruiting
4
25
 
Trilaciclib combined with chemotherapy
Department of Thoracic Oncology, Cancer Center, Bethune Hospital, Shanxi; Shanxi Bethune Hospital, Bethune Pioneer Medullary Protection - Bone Marrow Protection Special Research Fund Project
Advanced solid tumors
 
 
ChiCTR2500097520: A Multi-Cohort, Open-Label, Exploratory Clinical Study on the Myeloprotective and Immunomodulatory Effects of Trilaciclib in the Context of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Post-Surgery and First-Line Chemotherapy for Advanced Disease.

Not yet recruiting
4
102
 
Trilaciclib prophylaxis before chemotherapy; Trilaciclib prophylaxis before chemotherapy
Shanxi Province Cancer Hospital; Shanxi Province Cancer Hospital, The investigational drug for this project is provided by Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
 
 
ChiCTR2400086125: Trilaciclib in the treatment of small cell lung cancer chemotherapy or chemotherapy combined with immune regimen bone marrow protection multi-cohort, multi-center, open, exploratory clinical study

Not yet recruiting
4
50
 
Trilaciclib,Pre-chemotherapy
Datong Second People 's Hospital (Cancer Hospital); Datong Second People 's Hospital (Cancer Hospital), Not available
Small cell lung cancer
 
 
ChiCTR2400087694: A Single-Arm, Observational Study to Assess the Efficacy and Safety of Trilaciclib in Extensive Stage Small Cell Lung Cancer Patients with Chemotherapy Induced Grade 3/4 Myelosuppression Following Prior Chemotherapy

Recruiting
4
20
 
Trilaciclibe
Tangdu Hospital, Fourth Military Medical University; Tangdu Hospital, Fourth Military Medical University, "Bethune Pioneer Medullary Protection" - Bone Marrow Protection Special Scientific Research Fund Project
Small cell lung cancer
 
 
NCT05874401: Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

Recruiting
4
302
Europe, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor, Placebo, Topotecan, Hycamtin
G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
07/27
07/27
TRACES, NCT04902885: Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients

Checkmark Safety and efficacy data for extensive-stage small cell lung cancer
Feb 2022 - Feb 2022: Safety and efficacy data for extensive-stage small cell lung cancer
Completed
3
95
RoW
Trilaciclib, carboplatin, etoposide，or Topotecan, Trilaciclib plus chemotherapy, placebo, carboplatin, etoposide，or Topotecan, placebo plus chemotherapy
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
12/21
12/22
PRESERVE 1, NCT04607668 / 2019-003826-25: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

Jan 2023 - Jun 2023: From PRESERVE1 trial for metastatic colorectal cancer
Checkmark Approved Clinical Trial Application in China for metastatic CRC
Apr 2021 - Apr 2021: Approved Clinical Trial Application in China for metastatic CRC
Terminated
3
326
Europe, US, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, Placebo
G1 Therapeutics, Inc.
Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
02/23
03/23
PRESERVE 2, NCT04799249 / 2020-004930-39: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Completed
3
194
Europe, US, RoW
Trilaciclib, G1T28, COSELA, Placebo, 0.9% normal saline, 5 % Dextrose in water (D5W), Gemcitabine, Carboplatin
G1 Therapeutics, Inc.
TNBC - Triple-Negative Breast Cancer, Breast Cancer
05/24
05/24
NCT06364904: A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Not yet recruiting
3
210
RoW
Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, Tislelizumab, Cisplatin, Gemcitabine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Bladder Cancer
04/27
04/29
ChiCTR2400087886: A Multicenter, Phase III, Randomized Controlled Trial on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma

Not yet recruiting
3
192
 
Induction therapy: Gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.; Induction therapy: Treacilil + gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; d) Treacilil for injection 240mg/m2, d1, 2, 8 (4 hours before chemotherapy), intravenously A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Sun Yat-Sen Clinical Research 5010 Program
muscle invasive bladder cancer
 
 
NCT05112536: Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

Checkmark Initial results from P2 trial in early-stage TNBC at SABCS 2022
Dec 2022 - Dec 2022: Initial results from P2 trial in early-stage TNBC at SABCS 2022
Completed
2
24
US
Trilaciclib, COSELA®, G1T28, Cylophosphamide, CYTOXAN®, Doxorubicin, ADRIAMYCIN®, Paclitaxel, TAXOL®, Carboplatin (Investigator discretion), PARAPLATIN®, Pembrolizumab (Investigator discretion), KEYTRUDA®
G1 Therapeutics, Inc.
Triple Negative Breast Cancer, Breast Cancer
10/22
03/23
NCT06332287: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis

Recruiting
2
25
RoW
combination of Trilaciclib and Pemetrexed, G1T28, CDK 4/6 inhibitor
Jiangsu Province Nanjing Brain Hospital
NSCLC
11/24
06/25
PRESERVE3, NCT04887831 / 2021-000205-24: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Hourglass Jan 2023 - Jun 2023 : Presentation of data from PRESERVE3 trial for 1L bladder cancer
Checkmark Data from PRESERVE3 trial for 1L bladder cancer
Jan 2023 - Jan 2023: Data from PRESERVE3 trial for 1L bladder cancer
Hourglass Oct 2022 - Dec 2022 : Initial data from PRESERVE 3 trial in combination with trilaciclib for 1L metastatic urothelial carcinoma
Terminated
2
92
Europe, US, RoW
Trilaciclib, Cosela, G1T28, Gemcitabine, Cisplatin, Carboplatin, Avelumab, Bavencio
G1 Therapeutics, Inc.
Urothelial Carcinoma, Bladder Cancer, Myelosuppression Adult, Chemotherapy-induced Neutropenia, Metastatic Bladder Cancer
04/23
03/24
NCT05113966: Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Checkmark Presentation of data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Presentation of data from P2 trial for locally advanced or metastatic TNBC
Checkmark Data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Data from P2 trial for locally advanced or metastatic TNBC
Terminated
2
30
US
Trilaciclib, G1T28, CDK 4/6 inhibitor, Sacituzumab Govitecan-hziy, Trodelvy, IMMU-132
G1 Therapeutics, Inc.
Triple Negative Breast Cancer
11/23
06/24
Trila-CN-BC-01, NCT06955156: Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

Recruiting
2
50
RoW
Trilaciclib, Cosela
QIAO LI
Triple Negative Breast Cancer
05/25
07/25
NCT06328049: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

Recruiting
2
30
RoW
Trilaciclib Injection, CDK4/6 inhibitors
Taixing People's Hospital
NSCLC
02/25
08/25
NCT06151262: A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

Recruiting
2
30
RoW
Trilaciclib+mFOLFIRINOX, G1T28, CDK 4/6 inhibitor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Pancreatic Cancer
05/25
10/26
NCT06217003: Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

Not yet recruiting
2
20
RoW
Trilaciclib
The First Affiliated Hospital of Xinxiang Medical College
Osteosarcoma
02/25
08/25
NCT06297811: Myeloprotection With Trilaciclib in Pan-cancer Population

Not yet recruiting
2
132
RoW
Trilaciclib Injection, Paclitaxel, Carboplatin
Sun Yat-sen University
Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer, Cervical Cancer, Head And Neck Squamous Cell Carcinomas
09/25
12/27
NCT06370416: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Not yet recruiting
2
40
RoW
Trilaciclib, Trilaciclib Injection
Henan Cancer Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
04/25
12/25
NCT06569485: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

Recruiting
2
38
RoW
Trilaciclib+R-CHOP, G1T28
Sun Yat-sen University
DLBCL
12/24
12/27
NCT06490081: Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Recruiting
2
40
RoW
Trilaciclib, Trilaciclib combined with concurrent chemoradiotherapy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Myelosuppression
01/26
06/26
NCT06569459: Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

Recruiting
2
60
RoW
Trilaciclib Injection [Cosela], G1T28, CDK 4/6 inhibitor, Placebo
The First Affiliated Hospital with Nanjing Medical University
Esophageal Cancer
11/25
07/26
NCT05578326: Study of Trilaciclib and Lurbinectidin

Recruiting
2
30
US
Trilaciclib, Lurbinectedin
UNC Lineberger Comprehensive Cancer Center, G1 Therapeutics, Inc.
Lung Cancer, Small-cell Lung Cancer
12/25
12/27
NCT06698965: Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

Recruiting
2
52
RoW
Chemotherapy （Etoposide and Carboplatin）, Etoposide+Carboplatin, Immunotherapy （Envafolimab）, Envafolimab, Trilaciclib
Shanghai Chest Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Lung Cancer, Small Cell
10/29
10/29
NCT05900921: Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

Not yet recruiting
2
132
NA
Trilaciclib, Carboplatin, Paclitaxel, Tislelizumab
Sichuan University, Chengdu First people's hospital, Chengdu Second people's hospital, Chengdu Seventh People's Hospital, Mianyang Central Hospital, Shanxi Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, Heilongjiang Provincial Cancer Hospital, Enshi Central Hospital, Neijiang Hospital of Traditional Chinese Medicine
Advanced Squamous Non-Small-Cell Lung Cancer
10/24
12/25
NCT06699472: A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Recruiting
2
22
RoW
Chemotherapy, VDC/IE alternating chemotherapy, Trilaciclib Injection [Cosela]
Fudan University
Ewing Sarcoma, Myelosuppression
09/26
09/27
SMA-OS-001, NCT06714383: Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Recruiting
2
50
RoW
Trilaciclib, Cosela, Pirarubicin, Lobaplatin
Peking University People's Hospital
Osteosarcoma
07/25
11/25
NCT06714266: Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting
2
30
NA
Trilaciclib, chemotherapy, immune/targeted therapy
Shandong Cancer Hospital and Institute
Head and Neck Squamous Cell Carcinoma (HNSCC)
08/26
12/26
CCRT，LA-HNSCC, NCT06752798: Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Recruiting
2
30
RoW
Trilaciclib + Cisplatin
Hunan Cancer Hospital
Head and Neck Cancer Squamous Cell Carcinoma
09/25
12/25
PROTECT-1, NCT06929936: Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

Recruiting
2
33
RoW
Trilaciclib combined with Docetaxel
The First Affiliated Hospital of Xiamen University
Non-Small Cell Lung Cancer, Myelosuppression
05/26
06/26
PROTECT-2, NCT06992739: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)

Not yet recruiting
2
49
NA
Trilaciclib and Sacituzumab Tirumotecan
The First Affiliated Hospital of Xiamen University
NSCLC (Advanced Non-small Cell Lung Cancer), EGFR, Myelosuppression
06/26
05/27
ChiCTR2400087929: The myeloprotective effect of the CDK4/6 inhibitor, trilaciclib, in patients with locally advanced nasopharyngeal carcinoma receiving induction chemotherapy: a phase II clinical trial

Not yet recruiting
2
10
 
Induction chemotherapy plus trilaciclib
The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University, None
Locally advanced nasopharyngeal carcinoma
 
 
NCT05910034: Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

Not yet recruiting
2
132
NA
Trilaciclib+Envafolimab+Docetaxel, Envafolimab+Docetaxel, Docetaxel
Fudan University
Advanced Non-Small Cell Lung Cancer
12/25
06/26
ToPCourT, NCT06027268: Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Recruiting
2
36
US
Trilaciclib, COSELA, Pembrolizumab, KEYTRUDA, Gemcitabine, Gemzar, Carboplatin
Wake Forest University Health Sciences, Merck Sharp & Dohme LLC, G1 Therapeutics, Inc.
Metastatic Triple-Negative Breast Cancer
09/26
03/27
NCT05862610: The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC

Not yet recruiting
2
150
NA
Trilaciclib plus chemotherapy, Trilaciclib+AC-T, Chemotherapy, AC-T
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasm
12/26
06/27
SMA-BC-002, NCT05978648: Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Recruiting
2
116
RoW
Trilaciclib, COSELA®, G1T28, Epirubicin, Cyclophosphamide, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab, Pertuzumab
wang shusen
Breast Neoplasms
12/26
12/27
ChiCTR2500099059: Randomized controlled clinical study on the efficacy and safety of first-line treatment of extensive stage small cell lung cancer with combination therapy of trilaciclib, envafolimab, etoposide, and carboplatin

Recruiting
2
52
 
Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）+Trilaciclib; Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）
Shanghai Chest Hospital; Shanghai Chest?Hospital, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd
Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan
 
 
ChiCTR2500098340: An exploratory, controlled Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in combination with PD-1 monoclonal antibody and first-line chemotherapy in patients with advanced non-small cell lung cancer

Not yet recruiting
2
40
 
Trilaciclib +PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin; PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin
Liaoning Cancer Hospital & Institute; Liaoning Cancer Hospital & Institute
non-small cell lung cancer
 
 
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
COSELA, NCT06698692: Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Recruiting
N/A
200
RoW
Trilaciclib Injection [Cosela]
The First Affiliated Hospital with Nanjing Medical University
ESCC
12/24
04/25
ChiCTR2400079623: An exploratory clinical study on the efficacy and safety of trilaciclib combined with platinum-containing chemotherapy for bone marrow protection in advanced NSCLC

Recruiting
N/A
22
 
Patients with advanced NSCLC diagnosed by pathology were screened after signing informed consent, and eligible subjects were treated with trilaciclib before receiving platinum-containing double-drug chemotherapy, with a treatment cycle of 4-6 cycles. The administration regimen of trilaciclib was 240mg/m2 within 4h before chemotherapy. Dynamic changes of complete blood counts were recorded. Hematological toxicity, including febrile neutropenia and resulting infection; Transfusion of blood products and replenishment of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic antibiotic use; The QLQ-C30 scale was scored. Tumor imaging was evaluated according to RECIST1.1.
Xinyang Central Hospital; Xinyang Central Hospital, Beijing Bethune Charitable Foundation
NSCLC
 
 
ChiCTR2500097713: Myelopreservation with trilaciclib in patients with advanced ovarian carcinoma receiving paclitaxel and carboplatin: a randomized, double-blind, placebo-controlled phase II study

Not yet recruiting
N/A
71
 
240mg/m2,Q3W; 240mg/m2,Q3W
Sun yat-sen memorial hospital, Sun yat-sen university; Sun yat-sen memorial hospital, Sun yat-sen university, State Key Laboratory of Neurology and Oncology Drug Development
Advanced ovarian cancer
 
 
lerociclib (G1T38) / Walvax, Pharmacosmos
LEONARDA-1, NCT05054751: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

Completed
3
275
RoW
GB491+ Fulvestrant, test drug + Fulvestrant, Placebo+Fulvestrant, placebo control + Fulvestrant
Genor Biopharma Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
12/22
03/24
ENGOT-EN17, NCT05712941: Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer

Withdrawn
3
320
NA
Lerociclib, Letrozole 2.5mg, Placebo
EQRx International, Inc., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Endometrial Carcinoma
03/24
03/25
LEONARDA-2, NCT05851014: A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Recruiting
3
350
RoW
GB491 combined with Letrozole, Placebo combined with Letrozole
Genor Biopharma Co., Ltd.
Breast Cancer
01/26
01/27
NCT05085002 / 2021-005238-40: A Study of Lerociclib in Participants With Advanced Breast Cancer

Terminated
2
100
Europe, US, RoW
Lerociclib + Letrozole or Fulvestrant
EQRx, Inc.
Advanced Breast Cancer
11/23
11/23
NCT02983071 / 2016-001485-29: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Active, not recruiting
1/2
102
Europe, RoW
G1T38, lerociclib, Fulvestrant, Faslodex
G1 Therapeutics, Inc.
Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
06/23
10/23
NCT05860582: A Study of [14C]GB491 in Male Healthy Subjects

Completed
1
6
RoW
[14C]GB491
Genor Biopharma Co., Ltd.
Breast Cancer, Nonsmall Cell Lung Cancer
11/22
11/22
NCT05337657: A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer

Recruiting
1
10
RoW
GB491+Letrozole
Genor Biopharma Co., Ltd.
Advanced Breast Cancer
12/23
02/24
INX-315 / Incyclix Bio, Pharmacosmos
INX-315-01, NCT05735080: Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Recruiting
1/2
150
US, RoW
INX-315, Fulvestrant, faslodex, Abemaciclib, Verzenio
Incyclix Bio
Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Ovarian Cancer, CCNE1 Amplification, Solid Tumor, Advanced Cancer, Metastatic Cancer
12/25
06/26
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Cosela (trilaciclib) / Pharmacosmos
NCT05071703: Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Completed
4
30
RoW
Trilaciclib, Trilaciclib, carboplatin, etoposide#or Topotecan
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
04/22
11/22
ChiCTR2300075388: Clinical study of trilaciclib for the prevention of severe myelosuppression after chemotherapy in patients with bone and soft tissue sarcoma

Recruiting
4
550
 
Patients with bone and soft tissue sarcoma who had IV-degree bone marrow suppression in previous chemotherapy did not receive Turacilli for preventive treatment.; Patients with bone and soft tissue sarcoma who have experienced IV-degree bone marrow inhibition in chemotherapy should receive trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) before the next chemotherapy.; Patients with bone and soft tissue sarcoma will not receive prophylactic treatment until they plan to receive a high-risk chemotherapy regimen.; Before patients with bone and soft tissue sarcoma are proposed to receive high-FN-risk chemotherapy, trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) for preventive treatment.
Affiliated Sixth People's Hospital, Shanghai Jiaotong University; Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Self-financed
Bone and soft tissue sarcoma
 
 
ChiCTR2300073043: Study on the preventive effect of Cosela on chemotherapy induced bone marrow suppression in patients with advanced gastric cancer receiving systemic treatment

Recruiting
4
200
 
Systemic chemotherapy with Cosela ;Systemic chemotherapy
The First Affiliated Hospital of Air Force Military Medical University; The First Affiliated Hospital of Air Force Military Medical University, Sponsored by Simcere Pharmaceutical
gastric cancer
 
 
Multiple Cohort Exploration of Trilaciclib in First-Line Combination Chemotherapy for Advanced Solid Tumors, ChiCTR2400082382: A Multi-Cohort, Open-Label, Exploratory Clinical Study of Trilaciclib in Myeloprotection in First-Line Combination Chemotherapy Regimens for Advanced Solid Tumors

Recruiting
4
25
 
Trilaciclib combined with chemotherapy
Department of Thoracic Oncology, Cancer Center, Bethune Hospital, Shanxi; Shanxi Bethune Hospital, Bethune Pioneer Medullary Protection - Bone Marrow Protection Special Research Fund Project
Advanced solid tumors
 
 
ChiCTR2500097520: A Multi-Cohort, Open-Label, Exploratory Clinical Study on the Myeloprotective and Immunomodulatory Effects of Trilaciclib in the Context of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Post-Surgery and First-Line Chemotherapy for Advanced Disease.

Not yet recruiting
4
102
 
Trilaciclib prophylaxis before chemotherapy; Trilaciclib prophylaxis before chemotherapy
Shanxi Province Cancer Hospital; Shanxi Province Cancer Hospital, The investigational drug for this project is provided by Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
 
 
ChiCTR2400086125: Trilaciclib in the treatment of small cell lung cancer chemotherapy or chemotherapy combined with immune regimen bone marrow protection multi-cohort, multi-center, open, exploratory clinical study

Not yet recruiting
4
50
 
Trilaciclib,Pre-chemotherapy
Datong Second People 's Hospital (Cancer Hospital); Datong Second People 's Hospital (Cancer Hospital), Not available
Small cell lung cancer
 
 
ChiCTR2400087694: A Single-Arm, Observational Study to Assess the Efficacy and Safety of Trilaciclib in Extensive Stage Small Cell Lung Cancer Patients with Chemotherapy Induced Grade 3/4 Myelosuppression Following Prior Chemotherapy

Recruiting
4
20
 
Trilaciclibe
Tangdu Hospital, Fourth Military Medical University; Tangdu Hospital, Fourth Military Medical University, "Bethune Pioneer Medullary Protection" - Bone Marrow Protection Special Scientific Research Fund Project
Small cell lung cancer
 
 
NCT05874401: Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

Recruiting
4
302
Europe, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor, Placebo, Topotecan, Hycamtin
G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
07/27
07/27
TRACES, NCT04902885: Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients

Checkmark Safety and efficacy data for extensive-stage small cell lung cancer
Feb 2022 - Feb 2022: Safety and efficacy data for extensive-stage small cell lung cancer
Completed
3
95
RoW
Trilaciclib, carboplatin, etoposide，or Topotecan, Trilaciclib plus chemotherapy, placebo, carboplatin, etoposide，or Topotecan, placebo plus chemotherapy
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
12/21
12/22
PRESERVE 1, NCT04607668 / 2019-003826-25: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

Jan 2023 - Jun 2023: From PRESERVE1 trial for metastatic colorectal cancer
Checkmark Approved Clinical Trial Application in China for metastatic CRC
Apr 2021 - Apr 2021: Approved Clinical Trial Application in China for metastatic CRC
Terminated
3
326
Europe, US, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, Placebo
G1 Therapeutics, Inc.
Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
02/23
03/23
PRESERVE 2, NCT04799249 / 2020-004930-39: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Completed
3
194
Europe, US, RoW
Trilaciclib, G1T28, COSELA, Placebo, 0.9% normal saline, 5 % Dextrose in water (D5W), Gemcitabine, Carboplatin
G1 Therapeutics, Inc.
TNBC - Triple-Negative Breast Cancer, Breast Cancer
05/24
05/24
NCT06364904: A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Not yet recruiting
3
210
RoW
Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, Tislelizumab, Cisplatin, Gemcitabine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Bladder Cancer
04/27
04/29
ChiCTR2400087886: A Multicenter, Phase III, Randomized Controlled Trial on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma

Not yet recruiting
3
192
 
Induction therapy: Gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.; Induction therapy: Treacilil + gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; d) Treacilil for injection 240mg/m2, d1, 2, 8 (4 hours before chemotherapy), intravenously A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Sun Yat-Sen Clinical Research 5010 Program
muscle invasive bladder cancer
 
 
NCT05112536: Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

Checkmark Initial results from P2 trial in early-stage TNBC at SABCS 2022
Dec 2022 - Dec 2022: Initial results from P2 trial in early-stage TNBC at SABCS 2022
Completed
2
24
US
Trilaciclib, COSELA®, G1T28, Cylophosphamide, CYTOXAN®, Doxorubicin, ADRIAMYCIN®, Paclitaxel, TAXOL®, Carboplatin (Investigator discretion), PARAPLATIN®, Pembrolizumab (Investigator discretion), KEYTRUDA®
G1 Therapeutics, Inc.
Triple Negative Breast Cancer, Breast Cancer
10/22
03/23
NCT06332287: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis

Recruiting
2
25
RoW
combination of Trilaciclib and Pemetrexed, G1T28, CDK 4/6 inhibitor
Jiangsu Province Nanjing Brain Hospital
NSCLC
11/24
06/25
PRESERVE3, NCT04887831 / 2021-000205-24: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Hourglass Jan 2023 - Jun 2023 : Presentation of data from PRESERVE3 trial for 1L bladder cancer
Checkmark Data from PRESERVE3 trial for 1L bladder cancer
Jan 2023 - Jan 2023: Data from PRESERVE3 trial for 1L bladder cancer
Hourglass Oct 2022 - Dec 2022 : Initial data from PRESERVE 3 trial in combination with trilaciclib for 1L metastatic urothelial carcinoma
Terminated
2
92
Europe, US, RoW
Trilaciclib, Cosela, G1T28, Gemcitabine, Cisplatin, Carboplatin, Avelumab, Bavencio
G1 Therapeutics, Inc.
Urothelial Carcinoma, Bladder Cancer, Myelosuppression Adult, Chemotherapy-induced Neutropenia, Metastatic Bladder Cancer
04/23
03/24
NCT05113966: Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Checkmark Presentation of data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Presentation of data from P2 trial for locally advanced or metastatic TNBC
Checkmark Data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Data from P2 trial for locally advanced or metastatic TNBC
Terminated
2
30
US
Trilaciclib, G1T28, CDK 4/6 inhibitor, Sacituzumab Govitecan-hziy, Trodelvy, IMMU-132
G1 Therapeutics, Inc.
Triple Negative Breast Cancer
11/23
06/24
Trila-CN-BC-01, NCT06955156: Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

Recruiting
2
50
RoW
Trilaciclib, Cosela
QIAO LI
Triple Negative Breast Cancer
05/25
07/25
NCT06328049: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

Recruiting
2
30
RoW
Trilaciclib Injection, CDK4/6 inhibitors
Taixing People's Hospital
NSCLC
02/25
08/25
NCT06151262: A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

Recruiting
2
30
RoW
Trilaciclib+mFOLFIRINOX, G1T28, CDK 4/6 inhibitor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Pancreatic Cancer
05/25
10/26
NCT06217003: Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

Not yet recruiting
2
20
RoW
Trilaciclib
The First Affiliated Hospital of Xinxiang Medical College
Osteosarcoma
02/25
08/25
NCT06297811: Myeloprotection With Trilaciclib in Pan-cancer Population

Not yet recruiting
2
132
RoW
Trilaciclib Injection, Paclitaxel, Carboplatin
Sun Yat-sen University
Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer, Cervical Cancer, Head And Neck Squamous Cell Carcinomas
09/25
12/27
NCT06370416: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Not yet recruiting
2
40
RoW
Trilaciclib, Trilaciclib Injection
Henan Cancer Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
04/25
12/25
NCT06569485: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

Recruiting
2
38
RoW
Trilaciclib+R-CHOP, G1T28
Sun Yat-sen University
DLBCL
12/24
12/27
NCT06490081: Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Recruiting
2
40
RoW
Trilaciclib, Trilaciclib combined with concurrent chemoradiotherapy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Myelosuppression
01/26
06/26
NCT06569459: Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

Recruiting
2
60
RoW
Trilaciclib Injection [Cosela], G1T28, CDK 4/6 inhibitor, Placebo
The First Affiliated Hospital with Nanjing Medical University
Esophageal Cancer
11/25
07/26
NCT05578326: Study of Trilaciclib and Lurbinectidin

Recruiting
2
30
US
Trilaciclib, Lurbinectedin
UNC Lineberger Comprehensive Cancer Center, G1 Therapeutics, Inc.
Lung Cancer, Small-cell Lung Cancer
12/25
12/27
NCT06698965: Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

Recruiting
2
52
RoW
Chemotherapy （Etoposide and Carboplatin）, Etoposide+Carboplatin, Immunotherapy （Envafolimab）, Envafolimab, Trilaciclib
Shanghai Chest Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Lung Cancer, Small Cell
10/29
10/29
NCT05900921: Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

Not yet recruiting
2
132
NA
Trilaciclib, Carboplatin, Paclitaxel, Tislelizumab
Sichuan University, Chengdu First people's hospital, Chengdu Second people's hospital, Chengdu Seventh People's Hospital, Mianyang Central Hospital, Shanxi Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, Heilongjiang Provincial Cancer Hospital, Enshi Central Hospital, Neijiang Hospital of Traditional Chinese Medicine
Advanced Squamous Non-Small-Cell Lung Cancer
10/24
12/25
NCT06699472: A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Recruiting
2
22
RoW
Chemotherapy, VDC/IE alternating chemotherapy, Trilaciclib Injection [Cosela]
Fudan University
Ewing Sarcoma, Myelosuppression
09/26
09/27
SMA-OS-001, NCT06714383: Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Recruiting
2
50
RoW
Trilaciclib, Cosela, Pirarubicin, Lobaplatin
Peking University People's Hospital
Osteosarcoma
07/25
11/25
NCT06714266: Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting
2
30
NA
Trilaciclib, chemotherapy, immune/targeted therapy
Shandong Cancer Hospital and Institute
Head and Neck Squamous Cell Carcinoma (HNSCC)
08/26
12/26
CCRT，LA-HNSCC, NCT06752798: Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Recruiting
2
30
RoW
Trilaciclib + Cisplatin
Hunan Cancer Hospital
Head and Neck Cancer Squamous Cell Carcinoma
09/25
12/25
PROTECT-1, NCT06929936: Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

Recruiting
2
33
RoW
Trilaciclib combined with Docetaxel
The First Affiliated Hospital of Xiamen University
Non-Small Cell Lung Cancer, Myelosuppression
05/26
06/26
PROTECT-2, NCT06992739: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)

Not yet recruiting
2
49
NA
Trilaciclib and Sacituzumab Tirumotecan
The First Affiliated Hospital of Xiamen University
NSCLC (Advanced Non-small Cell Lung Cancer), EGFR, Myelosuppression
06/26
05/27
ChiCTR2400087929: The myeloprotective effect of the CDK4/6 inhibitor, trilaciclib, in patients with locally advanced nasopharyngeal carcinoma receiving induction chemotherapy: a phase II clinical trial

Not yet recruiting
2
10
 
Induction chemotherapy plus trilaciclib
The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University, None
Locally advanced nasopharyngeal carcinoma
 
 
NCT05910034: Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

Not yet recruiting
2
132
NA
Trilaciclib+Envafolimab+Docetaxel, Envafolimab+Docetaxel, Docetaxel
Fudan University
Advanced Non-Small Cell Lung Cancer
12/25
06/26
ToPCourT, NCT06027268: Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Recruiting
2
36
US
Trilaciclib, COSELA, Pembrolizumab, KEYTRUDA, Gemcitabine, Gemzar, Carboplatin
Wake Forest University Health Sciences, Merck Sharp & Dohme LLC, G1 Therapeutics, Inc.
Metastatic Triple-Negative Breast Cancer
09/26
03/27
NCT05862610: The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC

Not yet recruiting
2
150
NA
Trilaciclib plus chemotherapy, Trilaciclib+AC-T, Chemotherapy, AC-T
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasm
12/26
06/27
SMA-BC-002, NCT05978648: Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Recruiting
2
116
RoW
Trilaciclib, COSELA®, G1T28, Epirubicin, Cyclophosphamide, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab, Pertuzumab
wang shusen
Breast Neoplasms
12/26
12/27
ChiCTR2500099059: Randomized controlled clinical study on the efficacy and safety of first-line treatment of extensive stage small cell lung cancer with combination therapy of trilaciclib, envafolimab, etoposide, and carboplatin

Recruiting
2
52
 
Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）+Trilaciclib; Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）
Shanghai Chest Hospital; Shanghai Chest?Hospital, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd
Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan
 
 
ChiCTR2500098340: An exploratory, controlled Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in combination with PD-1 monoclonal antibody and first-line chemotherapy in patients with advanced non-small cell lung cancer

Not yet recruiting
2
40
 
Trilaciclib +PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin; PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin
Liaoning Cancer Hospital & Institute; Liaoning Cancer Hospital & Institute
non-small cell lung cancer
 
 
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
COSELA, NCT06698692: Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Recruiting
N/A
200
RoW
Trilaciclib Injection [Cosela]
The First Affiliated Hospital with Nanjing Medical University
ESCC
12/24
04/25
ChiCTR2400079623: An exploratory clinical study on the efficacy and safety of trilaciclib combined with platinum-containing chemotherapy for bone marrow protection in advanced NSCLC

Recruiting
N/A
22
 
Patients with advanced NSCLC diagnosed by pathology were screened after signing informed consent, and eligible subjects were treated with trilaciclib before receiving platinum-containing double-drug chemotherapy, with a treatment cycle of 4-6 cycles. The administration regimen of trilaciclib was 240mg/m2 within 4h before chemotherapy. Dynamic changes of complete blood counts were recorded. Hematological toxicity, including febrile neutropenia and resulting infection; Transfusion of blood products and replenishment of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic antibiotic use; The QLQ-C30 scale was scored. Tumor imaging was evaluated according to RECIST1.1.
Xinyang Central Hospital; Xinyang Central Hospital, Beijing Bethune Charitable Foundation
NSCLC
 
 
ChiCTR2500097713: Myelopreservation with trilaciclib in patients with advanced ovarian carcinoma receiving paclitaxel and carboplatin: a randomized, double-blind, placebo-controlled phase II study

Not yet recruiting
N/A
71
 
240mg/m2,Q3W; 240mg/m2,Q3W
Sun yat-sen memorial hospital, Sun yat-sen university; Sun yat-sen memorial hospital, Sun yat-sen university, State Key Laboratory of Neurology and Oncology Drug Development
Advanced ovarian cancer
 
 
lerociclib (G1T38) / Walvax, Pharmacosmos
LEONARDA-1, NCT05054751: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

Completed
3
275
RoW
GB491+ Fulvestrant, test drug + Fulvestrant, Placebo+Fulvestrant, placebo control + Fulvestrant
Genor Biopharma Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
12/22
03/24
ENGOT-EN17, NCT05712941: Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer

Withdrawn
3
320
NA
Lerociclib, Letrozole 2.5mg, Placebo
EQRx International, Inc., GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Endometrial Carcinoma
03/24
03/25
LEONARDA-2, NCT05851014: A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Recruiting
3
350
RoW
GB491 combined with Letrozole, Placebo combined with Letrozole
Genor Biopharma Co., Ltd.
Breast Cancer
01/26
01/27
NCT05085002 / 2021-005238-40: A Study of Lerociclib in Participants With Advanced Breast Cancer

Terminated
2
100
Europe, US, RoW
Lerociclib + Letrozole or Fulvestrant
EQRx, Inc.
Advanced Breast Cancer
11/23
11/23
NCT02983071 / 2016-001485-29: G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Active, not recruiting
1/2
102
Europe, RoW
G1T38, lerociclib, Fulvestrant, Faslodex
G1 Therapeutics, Inc.
Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
06/23
10/23
NCT05860582: A Study of [14C]GB491 in Male Healthy Subjects

Completed
1
6
RoW
[14C]GB491
Genor Biopharma Co., Ltd.
Breast Cancer, Nonsmall Cell Lung Cancer
11/22
11/22
NCT05337657: A Phase Ib Study of GB491 Plus Letrozole in Patients With Advanced Breast Cancer

Recruiting
1
10
RoW
GB491+Letrozole
Genor Biopharma Co., Ltd.
Advanced Breast Cancer
12/23
02/24
INX-315 / Incyclix Bio, Pharmacosmos
INX-315-01, NCT05735080: Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Recruiting
1/2
150
US, RoW
INX-315, Fulvestrant, faslodex, Abemaciclib, Verzenio
Incyclix Bio
Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Ovarian Cancer, CCNE1 Amplification, Solid Tumor, Advanced Cancer, Metastatic Cancer
12/25
06/26

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