NCT07716449Not yet recruitingPhase 3
A Randomized, Open-label, Multicenter Phase III Clinical Study of QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic CLDN18.2-positive, PD-L1 CPS < 5 Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 560
- Primary Endpoint
- Progression free survival (PFS)
Study Overview
Brief Summary
This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of CLDN18.2 positive, PD-L1 CPS < 5 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects voluntarily participate in the study and sign the informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Expected survival time ≥ 12 weeks;
- •Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma;
- •No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
- •At least one measurable lesion per RECIST v1.1;
- •Patients with adequate cardiac, liver, renal function, etc.
Exclusion Criteria
- •Known history of allergy to any component of the study drug;
- •Other second primary malignant neoplasm within 5 years;
- •Significant cardiovascular and cerebrovascular disorders within 6 months before randomization;
- •Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation;
- •Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc;
- •Previous treatment targeting CLDN18.2;
- •Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: Up to 44 months
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease by Blinded Independent Central Review (BICR) evaluation or death due to any cause (whichever occurs first).
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Recruiting
Phase 3
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBCNCT07424287Suzhou Suncadia Biopharmaceuticals Co., Ltd.236
Recruiting
Phase 3
Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLCResectable Stage II-IIIa NSCLCNCT07554846Fudan University759
Not yet recruiting
Phase 3
Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.NCT07608159Shanghai Pulmonary Hospital, Shanghai, China201
Not yet recruiting
Phase 3
Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT07569757Chia Tai Tianqing Pharmaceutical Group Co., Ltd.260
Recruiting
Phase 2
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial CancerNCT07314723Mabwell (Shanghai) Bioscience Co., Ltd.90