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- Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Phase 2 Basket Study of Disitamab Vedotin in Patients With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors That Express HER2: Ovarian and Endometrial Cancer Cohorts (DV-005; Trial in Progress) () - Feb 3, 2024 - Abstract #SGO2024SGO_681;
- ||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P1 trial, New P2 trial, Metastases: Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - Jan 26, 2024
P1, N=60, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- | Tyvyt (sintilimab) / Eli Lilly, Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Metastases: Disitamab Vedotin Combined With Sintilimab and XELOX Perioperative Treatment for Resectable Gastric Caner With HER2 Overexpression (clinicaltrials.gov) - Jan 25, 2024
P2, N=27, Not yet recruiting, Sponsor: Henan Cancer Hospital
- |||| Aidixi (disitamab vedotin) / Pfizer
New P2 trial: Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer (clinicaltrials.gov) - Jan 25, 2024
P2, N=160, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- || Tevimbra (tislelizumab) / BeiGene, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
P1/2 data, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: RC48-ADC combined with tislelizumab as neoadjuvant treatment in patients with HER2-positive locally advanced muscle-invasive urothelial bladder cancer: a multi-center phase Ib/II study (HOPE-03). (Pubmed Central) - Jan 25, 2024
The HOPE-03 trial provides a description of the safety profile of RC-48 and tislelizumab combination in the neoadjuvant treatment of HER2-positive locally advanced urothelial MIBC, and the efficacy is explored as well in this population. https://www.chictr.org.cn/showproj.html?proj=137111, identifier ChiCTR2200060153.
- |||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial primary completion date, Metastases: RC48-C012: A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 (clinicaltrials.gov) - Jan 24, 2024
P3, N=366, Recruiting, Sponsor: RemeGen Co., Ltd.
https://www.chictr.org.cn/showproj.html?proj=137111, identifier ChiCTR2200060153. Trial primary completion date: Dec 2023 --> Jun 2024
- |||||||| Aidixi (disitamab vedotin) / Pfizer
New P2/3 trial, Metastases: DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (clinicaltrials.gov) - Jan 24, 2024
P2/3, N=90, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Journal, Metastases: Long-term survival in a patient with multiple metastatic gastric cancer treated with PTX plus emvolimab and disitamab vedotin: case report and treatment experience: A case report. (Pubmed Central) - Jan 23, 2024
We demonstrated high survival of almost 3 years in a patient with gastric cancer that was complicated by bone, peritoneal, rectal, and bladder metastases. The combination of immunotherapy, targeted therapy, and neoadjuvant intraperitoneal systemic chemotherapy, along with the maintenance of nutritional status and CTCs could be a valuable modality for the subsequent treatment and observation of similar patients.
- || Loqtorzi (toripalimab) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
P1 data, Journal, Metastases: Disitamab vedotin (RC48) plus toripalimab for HER2-expressing advanced gastric or gastroesophageal junction and other solid tumours: a multicentre, open label, dose escalation and expansion phase 1 trial. (Pubmed Central) - Jan 18, 2024
P1
The findings of our phase 1 clinical trial support further investigation of HER2-targeted ADC plus immunotherapy in HER2-expressing G/GEJ cancer and pancancer treatment in the future. Beijing Municipal Medical Research Institutes, Beijing Medical Research Institute (Z200015).
- Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Evaluation Of The Effectiveness And Safety Of Disitamab Vedotin For HER2-Expressing Recurrent Cervical Cancer After Progression On Platinum-Based Treatment-A Single-Arm, Multicenter, Open-Label, Phase II Clinical Study (Session hall III (112)) - Jan 18, 2024 - Abstract #ESGO2024ESGO_423;
P2
Grade 3 or higher TRAEs included decreased neutrophil count (16%), increased gamma-glutamyl transferase (11%). Two patients (11.8%) experienced SAEs, and there were no deaths related to RC48.Conclusion RC48 demonstrates manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it a promising new treatment for HER2- expressed cervical cancer.
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial, Combination therapy, Surgery: A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery (clinicaltrials.gov) - Jan 17, 2024
P2, N=60, Not yet recruiting, Sponsor: Peking University First Hospital
- ||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Enrollment open, Combination therapy, Metastases: A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - Jan 17, 2024
P2, N=116, Recruiting, Sponsor: RemeGen Co., Ltd.
Two patients (11.8%) experienced SAEs, and there were no deaths related to RC48.Conclusion RC48 demonstrates manageable safety profile and positive efficacy in HER2-expressing r/m cervical cancer patients, suggesting it a promising new treatment for HER2- expressed cervical cancer. Not yet recruiting --> Recruiting
- | Tai'ai (telitacicept) / Rongchang Pharma
Trial primary completion date: Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients (clinicaltrials.gov) - Jan 17, 2024
P4, N=30, Recruiting, Sponsor: Fen Li
Not yet recruiting --> Recruiting Trial primary completion date: Dec 2023 --> Jun 2024
- Keytruda (pembrolizumab) / Merck (MSD), Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Phase 3 study of disitamab vedotin with pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma that expresses HER2 (DV-001; trial in progress) (W06) - Jan 15, 2024 - Abstract #EAU2024EAU_2738;
- Tevimbra (tislelizumab) / BeiGene, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Screen D: Trials in progress WUTSUP-02-II-Neo-Dis-Tis: Investigating the efficacy and safety of neoadjuvant tislelizumab plus disitamab vedotin with adjuvant tislelizumab in upper urinary tract carcinoma (EGPT) - Jan 15, 2024 - Abstract #EAU2024EAU_2656;
- Loqtorzi (toripalimab) / Shanghai Junshi Biosci, Coherus Biosci, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Screen D: Trials in progress RJBLC-A2A008: An open-label, single-arm, multi-center study on RC48-ADC combined with toripalimab and radiotherapy as bladder-preserving therapy in HER2 overexpression muscle-invasive bladder cancer (EGPT) - Jan 15, 2024 - Abstract #EAU2024EAU_2654;
- Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Clinical trials in muscle-invasive bladder cancer A real-world study from two centers regarding the combination treatment of Disitamab vedotin and immune checkpoint inhibitors for locally advanced bladder urothelial carcinoma: a novel bladder-preserving strategy (EGPT) - Jan 15, 2024 - Abstract #EAU2024EAU_1945;
- Tevimbra (tislelizumab) / BeiGene, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Neoadjuvant disitamab vedotin combined with tislelizumab for locally advanced upper urinary tract carcinoma: A pilot study for a phase II trial. (S06) - Jan 15, 2024 - Abstract #EAU2024EAU_736;
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Retrospective data, Journal, Checkpoint inhibition, Real-world evidence, IO biomarker, Real-world: Efficacy and safety analysis of a HER2-targeting antibody-drug conjugate combined with immune checkpoint inhibitors in solid tumors: a real-world study. (Pubmed Central) - Jan 8, 2024
Our study showed that Disitamab-Vedotin-based treatment, alone or in combination with ICIs, exerted considerable prognosis and good tolerance in patients with locally advanced or metastatic solid tumors, regardless of the HER2 expression levels. Whether combination therapy with ICIs provides greater therapeutic benefits compared to monotherapy needs to be further explored through randomized controlled trials.
- | Tai'ai (telitacicept) / Rongchang Pharma
Journal: Refractory generalized myasthenia gravis treated successfully with telitacicept: two cases report. (Pubmed Central) - Jan 8, 2024
Whether combination therapy with ICIs provides greater therapeutic benefits compared to monotherapy needs to be further explored through randomized controlled trials. No abstract available
- | Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2 (clinicaltrials.gov) - Jan 8, 2024
P1/2, N=42, Recruiting, Sponsor: Chinese PLA General Hospital
No abstract available Trial completion date: Sep 2024 --> Sep 2026 | Trial primary completion date: Sep 2023 --> Sep 2025
- | Benlysta (belimumab) / GSK, Tai'ai (telitacicept) / Rongchang Pharma
Journal: Safety and efficacy of telitacicept in refractory systemic lupus erythematosus patients who failed treatment with belimumab : A (Pubmed Central) - Jan 2, 2024
No major safety issues were seen in this group of patients. Telitacicept may be a
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial: Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - Jan 1, 2024
P2, N=20, Not yet recruiting, Sponsor: Fudan University
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion date, Trial initiation date, Trial primary completion date, Metastases: A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation (clinicaltrials.gov) - Jan 1, 2024
P1/2, N=26, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- ||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders (clinicaltrials.gov) - Jan 1, 2024
P3, N=166, Recruiting, Sponsor: RemeGen Co., Ltd.
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion date, Trial primary completion date, Real-world evidence, Real-world: RC48-ADC in Breast Cancer (clinicaltrials.gov) - Dec 31, 2023
P=N/A, N=45, Recruiting, Sponsor: RenJi Hospital
- || Review, Journal, Metastases: Advances in HER2-Targeted Treatment for Advanced/Metastatic Urothelial Carcinoma. (Pubmed Central) - Dec 29, 2023
In this review, we provided an in-depth overview of the advances in the research regarding HER2-targeted therapy and the role of HER2 in mUC. Furthermore, we also discussed the prospects of potential strategies aimed at overcoming anti-HER2 resistance, and summarize the novel anti-HER2 approaches for the management of mUC used in recent clinical trials.
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
New P2 trial, Metastases: RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations (clinicaltrials.gov) - Dec 29, 2023
P2, N=108, Not yet recruiting, Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- ||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment change: RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) - Dec 27, 2023
P2, N=30, Recruiting, Sponsor: RemeGen Co., Ltd.
Furthermore, we also discussed the prospects of potential strategies aimed at overcoming anti-HER2 resistance, and summarize the novel anti-HER2 approaches for the management of mUC used in recent clinical trials. N=18 --> 30
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment change, Metastases: A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Dec 27, 2023
P1/2, N=200, Recruiting, Sponsor: RemeGen Co., Ltd.
N=18 --> 30 N=51 --> 200
- | Fruzaqla (fruquintinib) / Takeda, Aidixi (disitamab vedotin) / Pfizer
Enrollment change, Metastases: HCCSC-C03: Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression (clinicaltrials.gov) - Dec 27, 2023
P4, N=51, Active, not recruiting, Sponsor: Zhongnan Hospital
N=51 --> 200 N=12 --> 51
- | Benlysta (belimumab) / GSK, Tai'ai (telitacicept) / Rongchang Pharma, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: The efficacy of rituximab plus belimumab or telitacicept in refractory lupus nephritis. (Pubmed Central) - Dec 25, 2023
N=12 --> 51 Rituximab followed by belimumab or telitacicept may be effective in inducing remission in refractory lupus nephritis, with tolerable adverse effects.
- || Tai'ai (telitacicept) / Rongchang Pharma
Review, Journal: Combination treatment with telitacicept, cyclophosphamide and glucocorticoids for severe Granulomatous polyangiitis: a case report and literature review. (Pubmed Central) - Dec 22, 2023
Telitacicept combined with CYC and glucocorticoids may be an induction therapy with safety and feasibility. However, more clinical trials are needed to validate the efficacy and safety of the therapeutic regimen.
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer, Kaitanni (cadonilimab) / Akesobio
New P2 trial, Metastases: A Study of RC48-ADC Combined With Cadonilimab?AK104?in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - Dec 21, 2023
P2, N=36, Recruiting, Sponsor: Shanxi Province Cancer Hospital
- |||| Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion date, Trial primary completion date, Metastases: RC48-C012: A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 (clinicaltrials.gov) - Dec 21, 2023
P3, N=366, Recruiting, Sponsor: RemeGen Co., Ltd.
However, more clinical trials are needed to validate the efficacy and safety of the therapeutic regimen. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||| Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Trial primary completion date, Metastases: A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression (clinicaltrials.gov) - Dec 20, 2023
P3, N=351, Recruiting, Sponsor: RemeGen Co., Ltd.
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- | Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Journal, Checkpoint inhibition, Real-world evidence, Real-world, Metastases: Immune checkpoint inhibitors enhanced the antitumor efficacy of disitamab vedotin for patients with HER2-positive or HER2-low advanced or metastatic gastric cancer: a multicenter real-world study. (Pubmed Central) - Dec 20, 2023
Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Compared with RC48 monotherapy, ICIs plus RC48 demonstrated superior third-line and beyond therapeutic efficacy for HER2-positive or HER2-low advanced and metastatic gastric cancer patients with manageable safety.
- | Aidixi (disitamab vedotin) / Pfizer
Trial completion date, Metastases: A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (clinicaltrials.gov) - Dec 20, 2023
P2, N=57, Active, not recruiting, Sponsor: RemeGen Co., Ltd.
Compared with RC48 monotherapy, ICIs plus RC48 demonstrated superior third-line and beyond therapeutic efficacy for HER2-positive or HER2-low advanced and metastatic gastric cancer patients with manageable safety. Trial completion date: Dec 2023 --> Jun 2024
- |||| Aidixi (disitamab vedotin) / Pfizer
New P2 trial, Combination therapy: DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer (clinicaltrials.gov) - Dec 20, 2023
P2, N=80, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- ||| misitatug blivedotin (RC88) / Rongchang Pharma
Enrollment open, Trial initiation date, Metastases: A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours (clinicaltrials.gov) - Dec 19, 2023
P1/2, N=82, Recruiting, Sponsor: RemeGen Co., Ltd.
Trial completion date: Dec 2023 --> Jun 2024 Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023
- || misitatug blivedotin (RC88) / Rongchang Pharma
Trial completion date, Trial primary completion date, Metastases: A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours (clinicaltrials.gov) - Dec 18, 2023
P1, N=81, Recruiting, Sponsor: RemeGen Co., Ltd.
Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023 Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
- ||| Aidixi (disitamab vedotin) / Pfizer
Trial completion, Trial completion date, Metastases: C003 CANCER: A Study of RC48-ADC in Subjects With Advanced Breast Cancer (clinicaltrials.gov) - Dec 18, 2023
P1/2, N=112, Completed, Sponsor: RemeGen Co., Ltd.
Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024 Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2023
- | Aidixi (disitamab vedotin) / Pfizer, RC98 / Rongchang Pharma
Trial primary completion date, Metastases: To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) (clinicaltrials.gov) - Dec 18, 2023
P1, N=24, Recruiting, Sponsor: RemeGen Co., Ltd.
Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2023 Trial primary completion date: Dec 2023 --> May 2024
- || Aidixi (disitamab vedotin) / Pfizer
Trial completion, Trial completion date, Metastases: A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - Dec 18, 2023
P2, N=19, Completed, Sponsor: RemeGen Co., Ltd.
Trial primary completion date: Dec 2023 --> May 2024 Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Jan 2023
- || Aidixi (disitamab vedotin) / Pfizer
Trial completion, Metastases: A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Dec 18, 2023
P1/2, N=37, Completed, Sponsor: RemeGen Co., Ltd.
Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Jan 2023 Active, not recruiting --> Completed
- || Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Trial completion date, Trial primary completion date, Monotherapy: RC48-C018: A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies (clinicaltrials.gov) - Dec 17, 2023
P2, N=120, Recruiting, Sponsor: RemeGen Co., Ltd.
Active, not recruiting --> Completed Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Jun 2023 --> Oct 2024
- |||| misitatug blivedotin (RC88) / Rongchang Pharma
New P2 trial, Monotherapy: RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov) - Dec 14, 2023
P2, N=88, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- ||| Aidixi (disitamab vedotin) / Pfizer
Enrollment open, Metastases: Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov) - Dec 14, 2023
P2, N=90, Recruiting, Sponsor: RemeGen Co., Ltd.
Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Jun 2023 --> Oct 2024 Not yet recruiting --> Recruiting
- Tevimbra (tislelizumab) / BeiGene, Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
WUTSUP-02-II-Neo-Dis-Tis: Investigating the efficacy and safety of neoadjuvant tislelizumab plus disitamab vedotin with adjuvant tislelizumab in upper urinary tract carcinoma (Level 1, West Hall; Poster Bd # M18) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_673;
Not yet recruiting --> Recruiting Secondary endpoints include overall survival, local recurrence free survival, distant metastasis free survival, FACT
- Keytruda (pembrolizumab) / Merck (MSD), Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
Phase 3 open-label, randomized, controlled study of disitamab vedotin with pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma that expresses HER2 (DV-001). (Level 1, West Hall; Poster Bd # M17) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_672;
P3
Maintenance therapy with avelumab may be used where approved and available after completion of 4-6 cycles of 1L platinum-based chemotherapy, if clinically appropriate...Enrollment is currently ongoing in the United States and planned globally. Clinical trial information: NCT05911295.