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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glumetinib+Osimertinib | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glumetinib | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective response rate) | the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective response rate, assessed as per investigators) | the sum ratio of partial response and complete response(assessed as per investigators) | through study completion, an average of 1 year |
| DOR(Duration of response) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shun LU, Doctor | Contact | +86-21-22200000 | 2153 | shun_lu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongqian Shu, Doctor | Jiangsu Province People's Hospital | Principal Investigator |
| Dingzhi Huang, Doctor | Tianjin Cancer Hospital | Principal Investigator |
| Yiping Zhang, Doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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Phase Ib: Glumetinib 300mg Combined With Osimertinib 80mg, Qd ,oral
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The time from the partial response and complete response of patient to patient progressive disease or death
| The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months |
| OS(Overall survival) | The time from the patient first dose to death | Through study completion, an average of 1 year |
| Zhejiang Province Cancer Hospital |
| Principal Investigator |
| Jianying Zhou, Doctor | Zhejiang University | Principal Investigator |
| ID | Term |
|---|---|
| C000729633 | glumetinib |
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