A Phase 3 interventional study of Glumetinib and Osimertinib mesylate in Non-Small Cell Lung Cancer, sponsored by Shanghai JMT-Bio Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Shanghai JMT-Bio Inc. · Phase 3, Interventional, and Treatment
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).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 350 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Shanghai JMT-Bio Inc. is the lead sponsor of 41 studies on the registry; 28 are open to participants now.
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Patients who are able to understand and voluntarily sign the written ICF; 2. Male or female patients aged ≥ 18 years (inclusive); 3. Patients with histologically or cytologically confirmed NSCLC, which is unresectable locally advanced or metastatic (Stage ⅢB, ⅢC, or Ⅳ) NSCLC according to the 8th edition of the TNM Staging System by the International Association for the Study of Lung Cancer (IASLC). Note: If the pathological type is mixed, it should be classified by primary cell type. However, if there are small cell components or neuroendocrine carcinoma components, enrollment will be not allowed; 4. Patients with EGFR-sensitive mutations confirmed by tumor histology or cytology or hematology before the first-line treatment with EGFR-TKIs; 5. Patients who have experienced documented imaging PD after treatment with first-, second- or third-generation EGFR-TKIs (gefitinib, erlotinib, icotinib, afatinib, dacomitinib, osimertinib, etc.); patients who have received prior adjuvant EGFR-TKI treatment after radical surgery may be enrolled if they have had PD within 6 months after the last dose of EGFR-TKIs.
Exclusion Criteria:
Patients will be administered glumetinib 300 mg/dose once daily and osimertinib mesylate 80 mg/dose once daily under fasting conditions in each 21-day treatment cycle. The treatment will continue until IRC-confirmed PD, death, intolerable toxicity, or withdrawal at the patient's discretion (whichever occurs first).
Drug: Glumetinib · Drug: Osimertinib mesylate
Patients will be administered pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 or carboplatin AUC=5 via intravenous infusion on the first day of each 3-week cycle, for a total of 4 cycles. Patients who have not experienced disease progression (PD) after completing the combination therapy will continue to receive maintenance treatment with pemetrexed following the same regimen until IRC-confirmed PD, death, intolerable toxicity, or withdrawal at the patient's discretion (whichever occurs first). Patients with IRC-confirmed PD may conditionally cross over to receive glumetinib combined with osimertinib at the discretion of the investigator and based on the patient's willingness. The end time of treatment will be determined based on the investigator's assessment of the patient's benefit from participating in the study.
Drug: Pemetrexed · Drug: Cisplatin or carboplatin
Patients will be administered glumetinib 300 mg/dose once daily once daily under fasting conditions in each 21-day treatment cycle.
Patients will be administered osimertinib mesylate 80 mg/dose once daily under fasting conditions in each 21-day treatment cycle.
Patients will be administered pemetrexed 500 mg/m\^2 via intravenous infusion on the first day of each 3-week cycle.
Patients will be administered cisplatin 75 mg/m\^2 or carboplatin AUC=5 via intravenous infusion on the first day of each 3-week cycle
PFS as assessed by IRC
Progression-Free-Survival (PFS ) as assessed by IRC
Time frame: Up to approximately 24 months after the first patient is enrolled
ORR as assessed by IRC
Objective response rate (ORR) as assessed by IRC
Time frame: Up to approximately 24 months after the first patient is enrolled
DCRas assessed by IRC
Disease control rate (DCR) as assessed by IRC
Time frame: Up to approximately 24 months after the first patient is enrolled
DOR as assessed by IRC
Duration of response (DOR) as assessed by IRC
Time frame: Up to approximately 24 months after the first patient is enrolled
OS
Overall survival
Time frame: Up to approximately 24 months after the first patient is enrolled
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Shanghai JMT-Bio Inc.