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This research study is a multicentre phase â… b/â…¡ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental A (part 1) : Fluzoparib + temozolomide | Experimental |
| |
| Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase â… b: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. | At the end of Cycle1 (each cycle is 21 days ) | |
| Phase â… b: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316. | Up to approximately 2 Years | |
| Phase â…¡: Progression Free Survival (PFS) at four months. | Up to approximately 2 Years | |
| Phase â…¡: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1. | Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier. | Up to approximately 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points. | up to approximately 2 Years |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| You Lu, MD | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610015 | China |
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Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316
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| temozolomide | Drug | Given PO |
|
| SHR-1316 | Biological | Given injection |
|
Duration of Response, determined using RECIST v1.1 criteria.
| Up to approximately 2 Years |
| Disease Control Rate | Disease Control Rate, determined using RECIST v1.1 criteria. | Up to approximately 2 Years |
| Time to Response | Time to Response, defined as the time from randomization to PR or CR. | Up to approximately 2 Years |
| Overall survival and overall survival at 6 months, 9months and 12 months | Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up. | Up to approximately 1 Year |
| 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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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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