Study on Durvalumab and Tremelimumab with or without Radiation Therapy for Metastatic Colorectal or Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02888743
This clinical trial is exploring the effects of combining two immunotherapy drugs, durvalumab and tremelimumab, with or without radiation therapy, to treat colorectal or non-small cell lung cancer that has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to see how well the combination of two immunotherapy drugs, durvalumab and tremelimumab, works with or without radiation therapy in treating colorectal or non-small cell lung cancer that has spread. Immunotherapy helps the body's immune system fight cancer, while radiation therapy uses high-energy rays to kill cancer cells. The study aims to find out if adding radiation therapy to the immunotherapy drugs can improve treatment outcomes.
Description
This study is divided into two groups based on the type of cancer: non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Each group will receive different treatments to see which combination works best.
For the NSCLC group, patients will be randomly assigned to one of three treatment plans:
- Plan A: Receive durvalumab and tremelimumab, along with high-dose radiation therapy starting in the second week.
- Plan B: Receive durvalumab and tremelimumab, along with low-dose radiation therapy starting in the second week.
- Plan C: Receive only durvalumab and tremelimumab without radiation.
For the CRC group, patients will be randomly assigned to one of two treatment plans:
- Plan A: Receive durvalumab and tremelimumab, along with high-dose radiation therapy starting in the second week.
- Plan B: Receive durvalumab and tremelimumab, along with low-dose radiation therapy starting in the second week.
After completing the treatment, patients will be monitored for up to 12 weeks to assess the effectiveness and safety of the treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of either non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).
- Have cancer that can be measured by scans or exams.
- Have cancer that has progressed after previous treatments.
- Be in good overall health with a performance status score of 0 or 1.
- Have normal organ and bone marrow function.
- Be willing to provide a tumor sample for research purposes.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after treatment.
- Men must agree to use contraception during the study and for a specified period after treatment.
- Be able to understand and sign a consent form.
- Weigh more than 30 kg and have a life expectancy of at least 12 weeks.
Exclusion Criteria
- Have received chemotherapy, biologic therapy, or radiotherapy within 3 weeks before starting the study.
- Have untreated brain metastases or spinal cord compression.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled illnesses or infections.
- Be pregnant or breastfeeding.
- Have a history of autoimmune diseases, except for certain stable conditions.
- Have another active cancer within the past 5 years, except for certain non-threatening cancers.
- Have received a live vaccine within 30 days before starting the study.
- Have unresolved side effects from previous cancer treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Smilow Cancer Hospital Care Center at Saint Francis | 06105 | Hartford | Connecticut |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Yale-New Haven Hospital North Haven Medical Center | 06473 | North Haven | Connecticut |
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