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

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 is a phase 3, randomised interventional study registered as NCT06847334 by Shanghai Henlius Biotech, with a registry enrolment figure of 772 participants, started 2025-04-27 and due to reach its primary completion in 2027-04-09. Interventions recorded: HLX17; US-sourced Keytruda®; EU-sourced Keytruda®. Conditions listed: Non-Squamous Non-Small Cell Lung Cancer. Primary outcome: Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d); Area under the serum concentration-time curve within a dosing interval at steady state (AUCss); Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1. Lung eligibility wording from the registry: "* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC". No results are recorded here; the registry entry is the source.