drugset / Trial / NCT06847334

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

NCT06847334 ↗

Phase 3 Not yet recruiting 772 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2025-04-27
Primary completion
2027-04-09
Completion
2028-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX17 Unknown 200 mg Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous