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NCT03382561 · ClinicalTrials.gov registry record · Phase 2
Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer
A Phase 2 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT03382561: Completed Phase 2 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03382561 is a Phase 2 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 160 participants, above the 142-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03382561, a Phase 2 study of Extensive Stage Lung Small Cell Carcinoma and Recurrent Lung Small Cell Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II clinical trial studies whether the addition of nivolumab to cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients with extensive stage small cell lung cancer. Chemotherapy drugs, such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin/carboplatin and etoposide together with nivolumab may work better in treating patients with extensive stage small cell lung cancer.
Primary Outcome
PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal p
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- BIOLOGICAL Nivolumab
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Kaiser Permanente-Fontana - Fontana
- Fresno Cancer Center - Fresno
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 2 |
What the finished NCT03382561 record still lists
NCT03382561 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with Extensive Stage Lung Small Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT03382561 names 20 study sites across 3 states, led by California, Alaska, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03382561 about?
NCT03382561 is a clinical study titled "Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer". This randomized phase II clinical trial studies whether the addition of nivolumab to cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients with extensive stage small cell lung cancer. Chemotherapy drugs, such as cisplatin, carboplatin, and etoposide, work in different...
What is the current status of trial NCT03382561?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2018-05-21. Estimated completion is 2025-01-31.
What conditions does trial NCT03382561 study?
This clinical trial studies the following conditions: Extensive Stage Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma.
What interventions are being tested in trial NCT03382561?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03382561?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03382561 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Extensive Stage Lung Small Cell Carcinoma
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 NCT03382561's enrollment target sits among peer trials
160 3rd of 16 higher than 14 of 16 other Extensive Stage Lung Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Extensive Stage Lung Small Cell Carcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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