NCT06110663

A Study of HS-10241 Combined With Almonertinib Versus Platinum-based Chemotherapy in Treatment of Advanced NSCLC With MET Amplification After Failure of EGFR-TKI Therapy

A Phase 3, Randomized, Open-label, Multicenter Study to Assess the Efficacy and Safety of HS-10241 Combined With Almonertinib Versus Pemetrexed Combined With Platinum in Metastatic or Locally Advanced NSCLC With MET Amplification After Failure of the Prior EGFR -TKI Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HS-10241, an oral and highly selective MET-TKI, may contribute to overcoming common acquired MET-based resistance mechanisms following prior EGFR-TKI monotherapy. This study is conducted to evaluate the efficacy and safety of HS-10241 combined with Almonertinib versus platinum-based chemotherapy in NSCLC with MET amplification after failure of EGFR-TKI treatment.

Detailed description

This is a phase 3, randomized, open-label, multicenter study to evaluate the efficacy and safety of HS-10241 in combination with Almonertinib versus platinum-based chemotherapy in patients with MET-amplified locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI therapy. All eligible patients were randomly assigned to experimental group (HS-10241 combined with Almonertinib) or control group (pemetrexed combined with platinum) at a ratio of 1:1. Patients in experimental group will receive HS-10241 300mg twice daily (BID) combined with Almonertinib 110mg once daily (QD) orally and will continue treatment until disease progression or other criteria for treatment discontinuation will be met. Patients in control group will receive the standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed for 4\~6 cycles. Participants will continue receive pemetrexed monotherapy until disease progression or other criteria for treatment discontinuation will be met. The efficacy and safety of the two groups will be evaluated after follow-up.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HS-10241+ Almonertinib	HS-10241 300mg twice daily (BID) combined with Almonertinib 110mg once daily (QD) orally, for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
DRUG	Pemetrexed + Cisplatin /Carboplatin	The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed for 4\~6 cycles (every 3 weeks). Participants will continue receive pemetrexed monotherapy until disease progression or other criteria for treatment discontinuation will be met.

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-12-30
• Completion: 2025-02-28
• First posted: 2023-11-01
• Last updated: 2023-11-01