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NCT02201992 · ClinicalTrials.gov registry record · Phase 3
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
A Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
- 20
- Study locations
NCT02201992: Active Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, sponsored by ECOG-ACRIN Cancer Research Group.
NCT02201992 is a Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 166 participants, roughly in line with the 165-participant average among 3 other Stage II Non-Small Cell Lung Cancer AJCC v7 trials with a reported enrollment target. The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201992, a Phase 3 study of Stage II Non-Small Cell Lung Cancer AJCC v7 and Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
Primary Outcome
Distribution 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 will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 5%. Other comparisons of groups will be made using the logrank test and Cox modeling. Estimate will be accompanied by the corresponding 90% confidence intervals.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Clinical Observation
- DRUG Crizotinib
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 Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
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
- Banner MD Anderson Cancer Center - Gilbert
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Banner-University Medical Center Phoenix - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2015-03-23 |
| Est. Completion | 2036-05-01 |
| Phase | Phase 3 |
What the registry record for NCT02201992 still lists
NCT02201992 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 165-participant average among 3 other Stage II Non-Small Cell Lung Cancer AJCC v7 trials with a reported enrollment target.
The record links to 8 conditions, with Stage II Non-Small Cell Lung Cancer AJCC v7 appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02201992 names 20 study sites across 3 states, led by Alaska, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02201992 about?
NCT02201992 is a clinical study titled "Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)". This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and imp...
What is the current status of trial NCT02201992?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2015-03-23. Estimated completion is 2036-05-01.
What conditions does trial NCT02201992 study?
This clinical trial studies the following conditions: Stage II Non-Small Cell Lung Cancer AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, ALK Gene Rearrangement.
What interventions are being tested in trial NCT02201992?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Clinical Observation (OTHER), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT02201992?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02201992 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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