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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

Name: 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 — clinical trial record (NCT06847334)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 3

SponsorShanghai Henlius Biotech

Started2025-04-27

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Shanghai Henlius Biotech

56 trials monitored

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Lung Cancer

4,033 trials monitored

See 210 trials at risk

Non-Small Cell Lung Cancer (NSCLC)

2,914 trials monitored

See 156 trials at risk

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.

Trial Details

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