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NCT02888743 · ClinicalTrials.gov registry record · Phase 2
Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer
A Phase 2 study of Metastatic Lung Non-Small Cell Carcinoma and Metastatic Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT02888743: Active Phase 2 study of Metastatic Lung Non-Small Cell Carcinoma and Metastatic Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).
NCT02888743 is a Phase 2 study of Metastatic Lung Non-Small Cell Carcinoma and Metastatic Colorectal Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 110 participants, above the 75-participant average among 39 other Metastatic Lung Non-Small Cell Carcinoma trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02888743, a Phase 2 study of Metastatic Lung Non-Small Cell Carcinoma and Metastatic Colorectal Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body (metastatic). Immunotherapy with durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.
Primary Outcome
Determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. NSCLC: The proportion of patients with response (complete response or partial response according to RECIST) will be compared for each pair-wise comparison of radiotherapy (RT)-containing therapy and control using chi- squared tests. The difference between the proportions responding will be presented with a 90% confidence interval. CRC: The proportion of patients with response will be presented with a 90% exact confidence in
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- RADIATION Radiation Therapy
- BIOLOGICAL Tremelimumab
Study Locations (20)
Connecticut
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital Care Center - Waterford - Waterford
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- University of California Davis Comprehensive Cancer Center - Sacramento
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
Florida
- Mayo Clinic in Florida - Jacksonville
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2027-01-02 |
| Phase | Phase 2 |
What the registry record for NCT02888743 still lists
NCT02888743 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 39 other Metastatic Lung Non-Small Cell Carcinoma trials with a reported enrollment target (47% higher).
The record links to 6 conditions, with Metastatic Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT02888743 names 20 study sites across 8 states, led by Connecticut, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02888743 about?
NCT02888743 is a clinical study titled "Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer". This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body (metastatic). Immunoth...
What is the current status of trial NCT02888743?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2017-08-14. Estimated completion is 2027-01-02.
What conditions does trial NCT02888743 study?
This clinical trial studies the following conditions: Metastatic Lung Non-Small Cell Carcinoma, Metastatic Colorectal Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7.
What interventions are being tested in trial NCT02888743?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Radiation Therapy (RADIATION), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02888743?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02888743 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02888743's enrollment target sits among peer trials
110 9th of 39 higher than 31 of 39 other Metastatic Lung Non-Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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