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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This is a randomized multi-arm trial evaluating the safety and efficacy of thoracic radiation therapy followed by either durvalumab as monotherapy or in combination with tremelimumab or olaparib in participants with Extensive-Stage Disease Small Cell Lung Cancer (ES-SCLC) who have completed a first-line platinum-based chemotherapy regimen and achieved ongoing complete response (CR), partial response (PR) or stable disease (SD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic Radiotherapy plus Durvalumab | No Intervention | This Arm is a standard of care Arm. Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 13 doses | |
| Thoracic Radiotherapy plus Durvalumab and 75mg Tremelimumab | Experimental | Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 4 doses and 75mg intravenously of Tremelimumab every 4 weeks for up to 4 doses |
|
| Thoracic Radiotherapy plus Durvalumab and Olaparib | Experimental | Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg orally of Olaparib twice a day |
|
| Thoracic Radiotherapy plus Durvalumab and 300mg Tremelimumab | Experimental | Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg Tremelimumab IV x 1 (single dose) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Participants in all arms will be administered 1500 mg of Durvalumab intravenously every 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Unacceptable Serious Adverse Events (SAEs) | Unacceptable toxicity status at the end of 13-week safety observation period with unacceptable toxicity defined as:
| 13 weeks |
| Phase IB: Progression Free Survival | Progression Free Survival (PFS) defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration or death due to any cause. Patients last known to be alive are censored at date of last contact. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival | Progression Free Survival (PFS) is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined above) or death due to any cause. Patients last known to be alive are censored at date of last contact. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto A Chiappori, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Tremelimumab | Drug | Participants in arm B will be administered 75 mg of Tremelimumab intravenously every 4 weeks for up to 4 doses. |
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| Olaparib Pill | Drug | Participants in arm C will be self-administer 300 mg of Olaparib orally. |
|
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| Thoracic Radiotherapy | Radiation | Thoracic Radiotherapy will be administered at 3 Gray units X 10 fractions |
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| Tremelimumab | Drug | Participants in arm D will be administered 300 mg of Tremelimumab intravenously in 1 single dose |
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| Overall Survival | Overall Survival (OS) will is defined as the duration from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. | Up to 12 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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 |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
| C531550 | olaparib |
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