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NCT03110978 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer
A Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 3
- Study locations
NCT03110978: Active Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03110978 is a Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 140 participants, above the 114-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (23% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03110978, a Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. 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. 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. Giving stereotactic body radiation therapy and nivolumab may work better at treating non-small cell lung cancer.
Primary Outcome
Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- BIOLOGICAL Nivolumab
Study Locations (3)
Texas
- MD Anderson in The Woodlands - Conroe
- M D Anderson Cancer Center - Houston
- MD Anderson West Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT03110978 still lists
NCT03110978 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (23% higher).
The record links to 10 conditions, with Recurrent Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT03110978 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03110978 about?
NCT03110978 is a clinical study titled "Stereotactic Body Radiation Therapy With or Without Nivolumab in Treating Patients With Stage I-IIA or Recurrent Non-small Cell Lung Cancer". This phase II trial studies how well stereotactic body radiation therapy with or without nivolumab works in treating patients with stage I-IIA non-small cell lung cancer or cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiati...
What is the current status of trial NCT03110978?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2017-06-26. Estimated completion is 2026-06-30.
What conditions does trial NCT03110978 study?
This clinical trial studies the following conditions: Recurrent Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Neuroendocrine Carcinoma, Stage IA1 Lung Cancer AJCC v8, Lung Neuroendocrine Neoplasm.
What interventions are being tested in trial NCT03110978?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03110978?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03110978 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Lung Non-Small Cell Carcinoma
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 NCT03110978's enrollment target sits among peer trials
140 6th of 30 higher than 25 of 30 other Recurrent Lung Non-Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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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