Clinical trial NCT04338243: Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors
Official title: Open Label, Multicenter Phase Ib / II Study of Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Negative T790M Mutation and Met Amplification
Keywords: MET amplification， T790
Lead sponsor: Haihe Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase Ib: Glumetinib 300mg Combined With Osimertinib 80mg, Qd ,oral
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ORR(Objective response rate)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: ORR(Objective response rate, assessed as per investigators)
timeFrame: through study completion, an average of 1 year
measure: DOR(Duration of response)
timeFrame: The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months
measure: OS(Overall survival)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Jiangsu Province People's Hospital
name: Yongqian Shu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Cancer Hospital
name: Dingzhi Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Province Cancer Hospital
name: Yiping Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Jianying Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: