A Randomized, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures;
• Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female;
• Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified;
• No EGFR sensitive mutations or ALK gene translocations.
• Expected survival ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1;
Locations
Other Locations
China
Shandong First Medical University Cancer Hospital
RECRUITING
Jinan
Contact Information
Primary
Jinming Yu, PhD
sdyujinming@126.com
0531-67626971
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 808
Treatments
Experimental: QL2107
Active_comparator: Keytruda®
Related Therapeutic Areas
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.