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The study is being conducted to evaluate the efficacy, safety and tolerability of famitinib combined with HS-10296 in subjects with advanced EGFR-mutant NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| famitinib, HS-10296 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| famitinib po | Drug | Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of Response (DepOR) | Percentage of total target lesion diameter reduced from baseline when at best overall response | From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanren Wang, PhD | Contact | +86 18036618570 | wangquanren@hrglobe.cn | |
| Weixia Li, Master | Contact | +86 15005136260 | liweixia@hrglobe.cn |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou, PhD | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji University, Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| HS-10296 po | Drug | Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study. |
|
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| From the first partial response or complete response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Disease Control Rate (DCR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Clinical Benefit Ratio (CBR) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | From the start of treatment to 6 months |
| 12-month-PFS | 12-month-progression free survival rate | From the start of treatment to 12 months |
| Progression-Free-Survival (PFS) | Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) | up to 2 years |
| Number of Participants with Clinically significant toxicity | Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | First cycle (21 days) |
| Rate of Adverse Events and Serious Adverse Events | Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | From the first drug administration to within 30 days after the last dose |