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The purpose of this study is to evaluate the safety and efficacy of SHR-1316 in combination with Fluzoparib(SHR-3162) in Small Cell Lung Cancer Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Experimental: A (Part 1): Fluzoparib and SHR -1316 | Experimental |
| |
| 2.Experimental: B (Part 1): Fluzoparib and SHR -1316 | Experimental |
| |
| 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.Experimental: A (Part 1): Fluzoparib and SHR -1316 | Drug | 1.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: 1.Number of Participants with AEs and SAEs | Up to approximately 24 months. | |
| Part 1: 2. RP2D: Recommended dose for phase II study | Up to approximately 24 months. | |
| Part 2: 1. ORR: Percentage of Participants With a CR or PR | Up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: 1. ORR: Percentage of Participants With a CR or PR | Up to approximately 24 months. | |
| Part 2: 1.Number of Participants with AEs and SAEs | Up to approximately 24 months. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310005 | China |
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| 2.Experimental: B (Part 1): Fluzoparib and SHR -1316 | Drug | 2.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV). |
|
| 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion | Drug | 3.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV). |
|
| Part 2: 2.DoR: Percentage of Participants With a CR or PR |
| Up to approximately 24 months. |
| Part 2: 3. DCR: Percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1. | Up to approximately 24 months. |
| Part 2: 4. PFS: PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first. | Up to approximately 24 months. |
| Part 2: 5. OS: Baseline until death from any cause | Up to approximately 24 months. |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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