Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, TTY Biopharm  >>  Phase 3
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22 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Lonsurf (trifluridine/tipiracil) / Otsuka
ROBiTS, jRCTs031210544: JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer

Active, not recruiting
3
420
Japan
Lonsurf (trifluridine/tipiracil) - Servier, Otsuka, Avastin (bevacizumab) - Roche
Shizuoka Cancer Center, National Cancer Center Japan
Colorectal cancer
 
 
SHR-A1811-309, CTR20234257: A randomized, open-label, active-controlled, multicenter phase III clinical study of SHR-A1811 for injection versus investigator-selected treatment regimen in patients with advanced colorectal cancer who have failed treatment with oxaliplatin, fluorouraci

Ongoing
3
120
China
trastuzumab rezetecan (SHR-A1811) - Jiangsu Hengrui Pharma, Lonsurf (trifluridine/tipiracil) - Servier, Otsuka, Stivarga (regorafenib) - Bayer, Fruzaqla (fruquintinib) - Takeda
Shanghai Hengrui Pharmaceutical Co., Ltd./ Jiangsu Hengrui Pharmaceutical Co., Ltd./ Suzhou Shengdia Biopharmaceutical Co., Ltd
Colorectal cancer
 
 
2020-004289-20: A Phase 3 Study of Lenvatinib Plus Pembrolizumab in Previously Treated Participants with Metastatic Colorectal Cancer

Not yet recruiting
3
434
Europe
Lenvatinib, E7080, Concentrate for solution for infusion, Capsule, hard, Film-coated tablet, KEYTRUDA (pembrolizumab, MK-3475), STIVARGA, LONSURF
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Colorectal Carcinoma, Colorectal cancer, Diseases [C] - Cancer [C04]
 
 
SOLSTICE, NCT03869892 / 2017-004059-22: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Active, not recruiting
3
856
Europe, RoW
Trifluridine/tipiracil hydrochloride (S95005), Capecitabine, Bevacizumab experimental, Bevacizumab control
Institut de Recherches Internationales Servier, ADIR, a Servier Group company
Metastatic Colorectal Cancer
06/21
06/24
2021-001309-60: MK-4280A Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer MK-4280A en comparación con el tratamiento de referencia en pacientes con Cancer Colorrectal metastásico positivo para PD-L1 tratados previamente

Not yet recruiting
3
432
Europe, RoW
favezelimab / pembrolizumab, TRIFLURIDINE / TIPIRACIL, MK-4280A, Solution for infusion, Film-coated tablet, Stivarga 40 mg film-coated tablets, Lonsurf 15 mg/6.14 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme LLC, Merck Sharp & Dohme Corp., MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme LLC, Merck Sharp & Dohme Corp., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Metastatic Colorectal Cancer cáncer colorrectal metastásico, Metastatic Colorectal Cancer cáncer colorrectal metastásico, Diseases [C] - Cancer [C04]
 
 
SUNLIGHT, NCT04737187 / 2020-001976-14: Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

Checkmark SUNLIGHT trial data in refractory mCRC at ASCO-GI 2023
Jan 2023 - Jan 2023: SUNLIGHT trial data in refractory mCRC at ASCO-GI 2023
Completed
3
492
Europe, US, RoW
Trifluridine/Tipiracil, TAS102, S 95005, Lonsurf, Bevacizumab, Avastin
Taiho Oncology, Inc., Institut de Recherches Internationales Servier
Refractory Metastatic Colorectal Cancer
07/22
09/23
LEAP-017, NCT04776148: Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/)

Active, not recruiting
3
480
Europe, Canada, Japan, US, RoW
pembrolizumab, KEYTRUDA®, MK-3475, lenvatinib, MK-7902, E7080, regorafenib, STIVARGA®, REGONIX®, TAS-102 (trifluridine and tipiracil), LONSURF®
Merck Sharp & Dohme LLC, Eisai Inc.
Colorectal Neoplasms
02/23
09/24
ALTAIR, NCT04457297: Initial Attack on Latent Metastasis Using TAS-102 for ct DNA Identified Colorectal Cancer Patients After Curative Resection

Recruiting
3
240
Japan, RoW
trifluridine and tipiracil, Placebo
National Cancer Center Hospital East, Alpha-A, Inc.
Colorectal Neoplasms, Trifluridine and Tipiracil, Circulating Tumor DNA
05/23
12/23
COLSTAR, NCT05223673 / 2021-003151-41: Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer

Terminated
3
7
Europe, Japan, US
Futuximab/modotuximab, Trifluridine/Tipiracil
Institut de Recherches Internationales Servier, ADIR, a Servier Group company
Metastatic Colorectal Cancer
06/23
06/23
2018-004845-18: LON-GAS A randomized study with TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without Bevacizumab in patients with pre-treated cancer in esophagus or stomach LON-GAS Et lodtrækningsforsøg med TRIFLURIDINE/TIPIRACIL (FTD/TPI) med eller uden bevacizumab til patienter med tidligere behandlet kræft i spiserør, mavemund eller mavesæk

Not yet recruiting
3
106
Europe
Solution for infusion, Film-coated tablet, Avastin, Lonsurf
Lene Bæksgaard Jensen, Danish Cancer Society, Novo Nordisk Foundation, Servier Danmark A/S
TRIFLURIDINE/TIPIRACIL (FTD/TPI) with or without bevacizumab in patients with platinum-refractory esophago-gastric adenocarcinoma Et randomiseret fase III studie med TRIFLURIDINE/TIPIRACIL (FTD/TPI) med eller uden bevacizumab til patienter med platin-resistent Øsofago-gastrisk adenocarcinom (LON-GAS)., Randomised trial in patients with advanced cancer in esophagus and stomach with Lonsurf with or without bevacizumab Lodtrækningsforsøg til patienter med udbredt kræft i spiserør, mavemund og mavesæk med Lonsurf med eller uden bevacizumab, Diseases [C] - Cancer [C04]
 
 
RAMTAS, NCT03520946 / 2017-004162-99: RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients

Active, not recruiting
3
430
Europe
Ramucirumab, TAS 102
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, Eli Lilly and Company, Trium Analysis Online GmbH
Colorectal Cancer
12/23
06/24
KEYFORM-007, NCT05064059: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Active, not recruiting
3
432
Europe, Canada, Japan, US, RoW
favezelimab/pembrolizumab, MK-4280A, regorafenib, STIVARGA®, REGONIX®, TAS-102, LONSURF®
Merck Sharp & Dohme LLC
Colorectal Cancer
08/24
11/25
SHR-A1811-309, NCT06199973: Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

Recruiting
3
120
RoW
SHR-A1811, TAS-102, Regorafenib , Fruquintinib
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Advanced Colorectal Cancer
04/26
06/26
D9802C00001, NCT06346392: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Recruiting
3
589
Europe, Canada, Japan, US, RoW
AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan, TAS-102, Apatinib
AstraZeneca
Gastric Cancer, Gastroesophageal Junction Cancer
04/26
10/26
NOTABLE-308, NCT06343116: Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

Not yet recruiting
3
420
NA
Nimotuzumab injection, Taixinsheng, Placebo, Trifluridine/tipiracil
Biotech Pharmaceutical Co., Ltd.
Refractory Metastatic Colorectal Cancer
04/27
04/27
MK-2870-015, NCT06356311: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma

Recruiting
3
450
Europe, Japan, US, RoW
Sacituzumab tirumotecan, SKB264. MK-2870, Trifluridine-Tipiracil, Irinotecan, Paclitaxel, Docetaxel
Merck Sharp & Dohme LLC
Gastroesophageal Cancer
01/27
05/28
KEYFORM-007, NCT05600309: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study

Active, not recruiting
3
94
RoW
favezelimab/pembrolizumab, MK-4280A, regorafenib, STIVARGA®, REGONIX®, TAS-102, LONSURF®
Merck Sharp & Dohme LLC
Colorectal Cancer
08/24
07/25
RELATIVITY-123, NCT05328908 / 2021-004285-35: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

Calendar Jan 2025 - Dec 2025: Data readout from RELATIVITY-123 trial for 2L+ MSS metastatic CRC
Active, not recruiting
3
700
Europe, Canada, Japan, US, RoW
Nivolumab-relatlimab FDC, BMS-986213, Regorafenib, Stivarga, TAS-102, Trifluridine/Tipiracil, Lonsurf
Bristol-Myers Squibb
Colorectal Neoplasms
01/25
05/28
CodeBreak 300, NCT05198934 / 2021-004008-16: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

Jul 2023 - Dec 2023: Data readout from CodeBreak 300 trial for colorectal cancer
Active, not recruiting
3
160
Europe, Japan, US, RoW
Sotorasib, AMG 510, Lumakras, Lumykras, Panitumumab, Vectibix, Trifluridine and Tipiracil, Lonsurf, Regorafenib, Stivarga
Amgen
Colorectal Cancer (CRC)
03/25
03/25
INTEGRATEIIb, NCT04879368 / 2020-004617-12: RegoNivo vs Standard of Care Chemotherapy in AGOC

Active, not recruiting
3
450
Europe, Japan, US, RoW
Regorafenib, Stivarga, Nivolumab, Opdivo, Docetaxel, Taxotere, Paclitaxel, Abraxane, Irinotecan, Camptosar, Trifluridine/Tipracil, Lonsurf
Australasian Gastro-Intestinal Trials Group, Bayer, Bristol-Myers Squibb, University of Sydney, Academic and Community Cancer Research United, Taiwanese Cooperative Oncology Group, Frankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, National Cancer Center Hospital East, Syneos Health
Gastro-Oesophageal Cancer
06/25
06/26
2017-000364-15: A trial testing TAS-102 therapy versus an alternative high-dose, intermittent scheduling for sunitinib in patients with metastatic colorectal carcinoma. Een onderzoek bij patiënten met uitgezaaid dikke darm en/of endeldarm kanker die een indicatie hebben voor behandeling met TAS-102 waarbij de behandeling met TAS-102 wordt vergeleken met een behandeling met hoge dosis, intermitterend, sunitinib.

Ongoing
2/3
60
Europe
sunitinib, L01XE04, Tablet, Sutent
VU University Medical Center, Department of Medical, VU University Medical Center, Department of Medical
Advanced colorectal tumors Gemetastaseerd colorectaal carcinoom, Metastasized (spread) or inoperable colorectal cancer Uitgezaaid (verspreid) of inoperabel colorectaal carcinoom, Diseases [C] - Cancer [C04]
 
 
SUNRISE-CRC, NCT03909724: Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)

Recruiting
2/3
60
Europe
Sunitinib Malate, Sutent, TAS 102, Lonsurf
Amsterdam UMC, location VUmc
Colorectal Cancer, Metastasis
07/21
07/22

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