{"entity":{"id":"nct06847334","kind":"trial","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","aka":[],"tldr":"A phase 3 trial in lung cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"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.","status":"planned","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT06847334","url":"https://clinicaltrials.gov/study/NCT06847334"}],"tags":["ctgov-ingest","lung-deep-dive"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06847334","phase":"3","setting":"A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","sponsor":"Shanghai Henlius Biotech","enrolled":772,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06847334/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}],"term":[{"id":"lung-trials-open-today","kind":"term","name":"Lung cancer trials open today (registry snapshot)","route":"/terms/lung-trials-open-today/"}]}}