NCT06847334View on ClinicalTrials.gov

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

772

Participants

Timeline

Start Date

April 27, 2025

Primary Completion Date

April 9, 2027

Study Completion Date

January 24, 2028

Conditions
Non-Squamous Non-Small Cell Lung Cancer
Interventions
DRUG

HLX17

HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.

DRUG

US-sourced Keytruda®

US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year.

DRUG

EU-sourced Keytruda®

EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY