A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
NCT06754644 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 808
Last updated 2025-06-10
Summary
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Conditions
Interventions
- DRUG
-
QL2107
200mg on day 1 of each 21-day cycle of the study
- DRUG
-
Pemetrexed
500 mg/m2 on Day 1 of each 21-day cycle of the study
- DRUG
-
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
- DRUG
-
Keytruda®
200mg on day 1 of each 21-day cycle of the study
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-15
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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