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NCT04214262 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
A Phase 3 study of Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
- 20
- Study locations
NCT04214262: Active Phase 3 study of Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04214262 is a Phase 3 study of Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 480 participants, above the 150-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (220% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04214262, a Phase 3 study of Lung Non-Small Cell Carcinoma and Stage II 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
- 480 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.
Primary Outcome
Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Atezolizumab
- PROCEDURE Positron Emission Tomography
- OTHER Fludeoxyglucose F-18
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Tower Cancer Research Foundation - Beverly Hills
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Loma Linda University Medical Center - Loma Linda
- Veterans Affairs Loma Linda Healthcare System - Loma Linda
- Tibor Rubin VA Medical Center - Long Beach
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Fremont - Rideout Cancer Center - Marysville
- Memorial Medical Center - Modesto
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Alaska
- Providence Alaska Medical Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 3 |
What the registry record for NCT04214262 still lists
NCT04214262 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, above the 150-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (220% higher).
The record links to 3 conditions, with Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04214262 names 20 study sites across 3 states, led by California, Arkansas, Alaska.
Frequently Asked Questions
What is clinical trial NCT04214262 about?
NCT04214262 is a clinical study titled "Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer". This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...
What is the current status of trial NCT04214262?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2020-08-13. Estimated completion is 2028-05-01.
What conditions does trial NCT04214262 study?
This clinical trial studies the following conditions: Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8.
What interventions are being tested in trial NCT04214262?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Positron Emission Tomography (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT04214262?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04214262 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
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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 NCT04214262's enrollment target sits among peer trials
480 3rd of 47 higher than 45 of 47 other Lung Non-Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Non-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.
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