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

Last updated: April 6, 2025
Sponsor: Shanghai JMT-Bio Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Cisplatin or carboplatin

Osimertinib mesylate

Glumetinib

Clinical Study ID

NCT06829459
SYH2065-002
  • Ages > 18
  • All Genders

Study Summary

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 randomized to the investigational group or the control group in a 1:1 ratio by the central randomization system (IWRS).

Eligibility Criteria

Inclusion

Inclusion 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 withhistologically or cytologically confirmed NSCLC, which is unresectable locallyadvanced or metastatic (Stage ⅢB, ⅢC, or Ⅳ) NSCLC according to the 8th editionof the TNM Staging System by the International Association for the Study ofLung Cancer (IASLC). Note: If the pathological type is mixed, it should beclassified by primary cell type. However, if there are small cell components orneuroendocrine carcinoma components, enrollment will be not allowed; 4.Patients with EGFR-sensitive mutations confirmed by tumor histology or cytologyor hematology before the first-line treatment with EGFR-TKIs; 5. Patients whohave experienced documented imaging PD after treatment with first-, second- orthird-generation EGFR-TKIs (gefitinib, erlotinib, icotinib, afatinib,dacomitinib, osimertinib, etc.); patients who have received prior adjuvantEGFR-TKI treatment after radical surgery may be enrolled if they have had PDwithin 6 months after the last dose of EGFR-TKIs.

  2. Patients with PD following EGFR-TKI treatment who meet any of the followingrequirements: a. EGFR T790M negative with MET amplification and/oroverexpression after PD following treatment with first- or second-generationEGFR-TKIs; b. MET amplification or overexpression after PD following treatmentwith third-generation EGFR inhibitors; MET amplification or overexpression intumor tissue samples as confirmed by the sponsor-designated central laboratory (meeting one of the following conditions):

  3. IHC: 3 +, ≥ 90%

  4. FISH: GCN ≥ 5 or MET/CEP7 ratio ≥ 2 7. Patients who have at least onemeasurable lesion meeting the RECIST v1.1 criteria. Lesions that havepreviously undergone local treatments such as radiotherapy can be considered astarget lesions upon confirmed progression. Brain metastases will not beconsidered as target lesions.

Exclusion

Exclusion Criteria:

  1. Patients with prior treatment with targeted MET drugs; 2. Patients withT790M-positive mutation after PD following treatment with first- orsecond-generation EGFR-TKIs; 3. Patients who are positive for other drivergenes, such as ALK/ROS1 positive after PD following EGFR-TKI treatment; 4.Patients with prior systemic anti-tumor therapy (including chemotherapy andimmunotherapy) for advanced NSCLC other than EGFR-TKIs;

Study Design

Total Participants: 350
Treatment Group(s): 4
Primary Treatment: Cisplatin or carboplatin
Phase: 3
Study Start date:
April 03, 2025
Estimated Completion Date:
February 15, 2029

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

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