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NCT02595944 · ClinicalTrials.gov registry record · Phase 3
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)
A Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Stage IB Lung Non-Small Cell Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 903
- Enrollment target
- 20
- Study locations
NCT02595944: Active Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Stage IB Lung Non-Small Cell Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
NCT02595944 is a Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Stage IB Lung Non-Small Cell Carcinoma AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 903 participants, below the 1,477-participant average among 6 other Stage IIIA Lung Non-Small Cell Cancer AJCC v7 trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595944, a Phase 3 study of Stage IIIA Lung Non-Small Cell Cancer AJCC v7 and Stage IB Lung Non-Small Cell Carcinoma AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 903 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III ALCHEMIST treatment trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. 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.
Primary Outcome
DFS distributions will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparisons of DFS will use a logrank tests stratified on the randomization stratification factors with a one-sided type I error rate corresponding to the significance level associated with population being analyzed; that is, 1.5% for the overall population and 1% for the \>= 50% population. The latter test will only be performed
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- BIOLOGICAL Nivolumab
- OTHER Observation Activity
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Southern Cancer Center PC-Daphne - Daphne
- Southern Cancer Center PC-Mobile - Mobile
- Southern Cancer Center PC-Providence - Mobile
- Southern Cancer Center PC-Springhill - Mobile
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alaska
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- John L McClellan Memorial Veterans Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 903 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT02595944 still lists
NCT02595944 is an interventional study that assigns participants to a tested intervention. The registered 903 participants enrollment target is mid-sized for trials with a published cap, below the 1,477-participant average among 6 other Stage IIIA Lung Non-Small Cell Cancer AJCC v7 trials with a reported enrollment target (39% lower).
The record links to 3 conditions, with Stage IIIA Lung Non-Small Cell Cancer AJCC v7 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02595944 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02595944 about?
NCT02595944 is a clinical study titled "Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)". This phase III ALCHEMIST treatment trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interf...
What is the current status of trial NCT02595944?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 903 participants. The study started on 2016-07-22. Estimated completion is 2026-12-31.
What conditions does trial NCT02595944 study?
This clinical trial studies the following conditions: Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7.
What interventions are being tested in trial NCT02595944?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Nivolumab (BIOLOGICAL), Observation Activity (OTHER).
Who is sponsoring clinical trial NCT02595944?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02595944 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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