Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
HLX17 vs. Keytruda in First-Line Advanced Non-Squamous NSCLC
NCT06847334Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Apr 2025
- Primary completion
- Apr 2027
- Sponsor
- Henlius
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
01
Overview
Phase 3, randomised, double-blind trial of pembrolizumab in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (3 arms), sponsored by Henlius. Primary endpoints: Area under the serum concentration-time curve from time 0 to 21 days, Area under the serum concentration-time curve within a dosing interval at steady state at 1 year and 1 more. Planned start Apr 2025; status: not yet recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
HLX17 Group
HLX17 + Carboplatin + Pemetrexed
US-sourced Keytruda Group
US-Keytruda + Carboplatin + Pemetrexed, switching to HLX17 after week 24
EU-sourced Keytruda Group
EU-Keytruda + Carboplatin + Pemetrexed
03
Who it enrols
Patients with stage IV non-squamous NSCLC without EGFR/ALK/ROS1 mutations who have not received prior systemic treatment.
04
Endpoints
Primary
Area under the serum concentration-time curve from time 0 to 21 days
Area under the serum concentration-time curve within a dosing interval at steady state
Best Objective Response Rate
Secondary
Maximum serum drug concentration
Trough serum drug concentration
Area under the serum concentration-time curve from time 0 to infinity
Time to reach maximum serum drug concentration
Elimination half life
Objective Response Rate
Duration of Response
Progression Free Survival
Beyond the preview
Go deeper on NCT06847334.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT06847334.