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NCT03391869 · ClinicalTrials.gov registry record · Phase 3
Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
A Phase 3 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 339
- Enrollment target
- 5
- Study locations
NCT03391869: Active Phase 3 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03391869 is a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 339 participants, above the 94-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (261% higher). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03391869, a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 339 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase III trial studies how well nivolumab and ipilimumab works with or without local consolidation therapy in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Local consolidation therapy, such as surgery or radiation therapy, may improve survival outcomes in patients with non-small cell lung cancer. It is not yet known whether giving nivolumab and ipilimumab with local consolidation therapy works better than nivolumab and ipilimumab alone in treating patients with stage IV non-small cell lung cancer.
Primary Outcome
The type I error of 0.10 for the entire study is divided in half (0.10/2 = 0.05) allowing for a Type I error of 0.05 for each of the efficacy endpoints.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION Radiation Therapy
- BIOLOGICAL Nivolumab
- PROCEDURE Local Consolidation Therapy
- BIOLOGICAL Ipilimumab
Study Locations (5)
Texas
- MD Anderson in The Woodlands - Conroe
- M D Anderson Cancer Center - Houston
- MD Anderson West Houston - Houston
- MD Anderson League City - League City
- MD Anderson in Sugar Land - Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2017-12-29 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 3 |
What the registry record for NCT03391869 still lists
NCT03391869 is an interventional study that assigns participants to a tested intervention. The registered 339 participants enrollment target is mid-sized for trials with a published cap, above the 94-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (261% higher).
The record links to 3 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03391869 lists 5 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT03391869 about?
NCT03391869 is a clinical study titled "Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer". This phase III trial studies how well nivolumab and ipilimumab works with or without local consolidation therapy in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the can...
What is the current status of trial NCT03391869?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 339 participants. The study started on 2017-12-29. Estimated completion is 2027-03-31.
What conditions does trial NCT03391869 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma, Lung Adenocarcinoma.
What interventions are being tested in trial NCT03391869?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Local Consolidation Therapy (PROCEDURE), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03391869?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03391869 being conducted?
This trial has 5 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Lung Cancer AJCC v8
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 NCT03391869's enrollment target sits among peer trials
339 6th of 81 higher than 76 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 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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