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

Source: https://onco.cc/trials/nct06847334/  
OnCo record `nct06847334` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-25
- Tags: ctgov-ingest; lung-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT06847334: https://clinicaltrials.gov/study/NCT06847334

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- terms: [Lung cancer trials open today (registry snapshot)](https://onco.cc/terms/lung-trials-open-today/)

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