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NCT03923270 · ClinicalTrials.gov registry record · Phase 1
Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer
A Phase 1 study of Small-cell Lung Cancer and Small Cell Lung Cancer Extensive Stage, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03923270: Active Phase 1 study of Small-cell Lung Cancer and Small Cell Lung Cancer Extensive Stage, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03923270 is a Phase 1 study of Small-cell Lung Cancer and Small Cell Lung Cancer Extensive Stage that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 25 participants, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03923270, a Phase 1 study of Small-cell Lung Cancer and Small Cell Lung Cancer Extensive Stage, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Unacceptable toxicity status at the end of 13-week safety observation period with unacceptable toxicity defined as: * Any grade 4 immune related adverse event (irAE), * Any ≥ grade 3 noninfectious pneumonitis, * Any ≥ grade 3 colitis, * Any grade 3 irAE, excluding colitis or pneumonitis, that does not downgrade to grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to ≤ grade 1 or baseline within 14 days, * L
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
- DRUG Olaparib Pill
- RADIATION Thoracic Radiotherapy
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT03923270 still lists
NCT03923270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT03923270 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03923270 about?
NCT03923270 is a clinical study titled "Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer". 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-...
What is the current status of trial NCT03923270?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-06-06. Estimated completion is 2026-12.
What conditions does trial NCT03923270 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Small Cell Lung Cancer Extensive Stage.
What interventions are being tested in trial NCT03923270?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Olaparib Pill (DRUG), Thoracic Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT03923270?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03923270 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Small-cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03923270's enrollment target sits among peer trials
25 73rd of 79 higher than 6 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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