Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer
NCT03923270 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-04-01
Summary
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).
Conditions
- Small Cell Lung Cancer Extensive Stage
- Small-cell Lung Cancer
Interventions
- DRUG
-
Participants in all arms will be administered 1500 mg of Durvalumab intravenously every 4 weeks.
- DRUG
-
Tremelimumab
Participants in arm B will be administered 75 mg of Tremelimumab intravenously every 4 weeks for up to 4 doses.
- DRUG
-
Olaparib Pill
Participants in arm C will be self-administer 300 mg of Olaparib orally.
- RADIATION
-
Thoracic Radiotherapy
Thoracic Radiotherapy will be administered at 3 Gray units X 10 fractions
- DRUG
-
Tremelimumab
Participants in arm D will be administered 300 mg of Tremelimumab intravenously in 1 single dose
Sponsors & Collaborators
- collaborator INDUSTRY
-
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Alberto A Chiappori, MD · H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-06
- Primary Completion
- 2023-06-01
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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