NCT06672068

A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC

To Evaluate the Efficacy and Safety of TY-9591 Tablets Combined With Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study was a parallel, randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of TY-9591 combined with platinum-based chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations.

Detailed description

Participants were randomly assigned in a 1:1 ratio to either cohort 1 or cohort 2 for 21-day treatment cycles until disease progression (RECIST v1.1 criteria), treatment discontinuation criteria, withdrawal criteria, or study discontinuation, whichever occurred first. After the subjects terminate or withdraw from this study, the investigators can use reasonable follow-up treatment according to the subjects' condition.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin	TY-9591 80mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w\*4 cycles）
DRUG	TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin	TY-9591 160mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w\*4 cycles）

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-11-04
• Last updated: 2024-12-30