MedTrace Logo

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

NCT06110663 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2023-11-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-30
Primary Completion
2024-12-30
Completion
2025-02-28

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110663 on ClinicalTrials.gov