NCT06754644

A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 808 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.

Conditions

• NSCLC

Interventions

Type	Name	Description
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	Carboplatin	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

Timeline

• Start date: 2025-01-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-01
• Last updated: 2025-06-10

Locations

1 site across 1 country: China