A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs

The is a randomized, controlled, open-label Phase III clinical study to evaluate the efficacy and safety of glumetinib combined with osimertinib mesylate versus platinum-based doublet chemotherapy in non-small cell lung cancer( NSCLC) patients with MET amplification and/or overexpression after resistance to EGFR-TKIs.. Approximately 350 NSCLC patients with MET amplification and/or overexpression after previous treatment with EGFR-TKIs are planned to be enrolled. After patients sign the informed consent form (ICF), those who are eligible for enrollment after screening examinations will be rand

Trial Details

NCT ID

NCT06829459

Phase

PHASE3

Sponsor

Shanghai JMT-Bio Inc.

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

Glumetinib
Osimertinib mesylate
Pemetrexed
Cisplatin or carboplatin

Locations (sample)

Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

1\. Patients who are able to understand and voluntarily sign the written ICF; 2. Male or female patients aged ≥ 18 years (inclusive); 3. Patients w…
6\. Patients with PD following EGFR-TKI treatment who meet any of the following requirements: a. EGFR T790M negative with MET amplification and/or …
IHC: 3 +, ≥ 90%
FISH: GCN ≥ 5 or MET/CEP7 ratio ≥ 2 7. Patients who have at least one measurable lesion meeting the RECIST v1.1 criteria. Lesions that have previou…

For full eligibility, visit ClinicalTrials.gov.

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