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

This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.

NCT Number	NCT06847334
Lead Sponsor	Shanghai Henlius Biotech
Conditions	Non-Squamous Non-Small Cell Lung Cancer
Enrollment	772 participants
Start Date	2025-04-27
Primary Completion	2027-04-09 (estimated)
Study Completion	2028-01-24 (estimated)
Updated on ClinicalTrials.gov	2025-02-26