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YL202 vs Docetaxel in Advanced/Metastatic EGFR-Mutated Non-Squamous NSCLC
NCT07416994Phase 3
Key facts
- Status
- Recruiting
- Start
- Mar 2026
- Primary completion
- Aug 2028
- Countries
- 1
- Sponsor
- MediLink Therapeutics
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- YL202
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 3, randomised, open-label trial of YL202 in non-small cell lung cancer (NSCLC) (2 arms), sponsored by MediLink Therapeutics. Primary endpoints: Overall Survival at 36 months and Progression-Free Survival at 36 months. Started Mar 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
YL202
YL202 2.0mg/kg IV on Day 1 of each 3-week cycle
Docetaxel
Docetaxel 75mg/m2 IV on Day 1 of each 3-week cycle
03
Who it enrols
Adults aged 18-75 with locally advanced or metastatic non-squamous NSCLC with EGFR Exon 19 deletion or Exon 21 L858R mutation, who have received prior EGFR TKI and platinum-based chemotherapy. Excludes patients with small cell lung cancer components, history of ILD, prior HER3-targeted therapy, or prior topoisomerase I inhibitors.
04
Endpoints
Primary
Overall Survival
Progression-Free Survival
Secondary
Progression-Free Survival
Overall Response Rate
Trough Concentration
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