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NCT04092283 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
A Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT04092283: Active Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04092283 is a Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 660 participants, above the 84-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (686% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04092283, a Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIIB Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.
Primary Outcome
Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- BIOLOGICAL Durvalumab
- DRUG Paclitaxel
- DRUG Etoposide
Study Locations (20)
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
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Banner Boswell Medical Center - Sun City
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
- Onvida Health Yuma Medical Center - Yuma
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2020-04-29 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04092283 still lists
NCT04092283 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (686% higher).
The record links to 6 conditions, with Stage III Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04092283 names 20 study sites across 3 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04092283 about?
NCT04092283 is a clinical study titled "Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer". This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab,...
What is the current status of trial NCT04092283?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2020-04-29. Estimated completion is 2028-12-31.
What conditions does trial NCT04092283 study?
This clinical trial studies the following conditions: Stage III Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIA Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8.
What interventions are being tested in trial NCT04092283?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Durvalumab (BIOLOGICAL), Paclitaxel (DRUG), Etoposide (DRUG).
Who is sponsoring clinical trial NCT04092283?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04092283 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III 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 NCT04092283's enrollment target sits among peer trials
660 1st of 40 higher than 40 of 40 other Stage III Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III 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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