Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors

Haihe Biopharma

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Negative T790M Mutation and Met Amplification

Treatments: Drug: Glumetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04338243

SCC244-203

Details and patient eligibility

About

To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.

Full description

To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Can fully understand and sign informed consent form(ICF) voluntarily Male and female patients 18-80 (inclusive) years of age
• Stage: IIIb/IIIc/IV (AJCC version 8)
• ECOG Performance Status (PS): 0-1
• At least one measurable lesion as per RECIST 1.1

Exclusion criteria

• Subjects with characterizedALK or ROS1 activating mutations that predict sensitivity to anti-ALK-therapy or anti-ROS1-therapy; T790 mutations is uknown or positive
• Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for ≥3 months at least two weeks prior to entering the study.)
• Prior exposure to MET-directed or third generation EGFR inhibitors therapy Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy
• Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Glumetinib+Osimertinib

Experimental group

Description:

The investigational product Glumetinib will be orally administrated when fasting at dose level of 300mg QD and Osimertinib will be orally administrated when fasting at dose level of 80mg QD

Treatment:

Drug: Glumetinib