Negative T790M Mutation and Met Amplification
Conditions
Keywords
MET amplification， T790
Brief summary
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.
Detailed 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.
Interventions
DRUGGlumetinib
Phase Ib is a dose escalation study, the initial dose of Glumetinib is 300mg, then will be escalated to 400mg，according to the result of Phase Ib， will confirm the RP2D
Sponsors
Haihe Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase Ib: Glumetinib 300mg Combined With Osimertinib 80mg, Qd ,oral
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR(Objective response rate) | through study completion, an average of 1 year | the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR(Objective response rate, assessed as per investigators) | through study completion, an average of 1 year | the sum ratio of partial response and complete response(assessed as per investigators) |
| DOR(Duration of response) | The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months | The time from the partial response and complete response of patient to patient progressive disease or death |
| OS(Overall survival) | Through study completion, an average of 1 year | The time from the patient first dose to death |
Countries
China
Contacts
Primary ContactShun LU, Doctor
Outcome results
None listed