Immunotherapy + Radiation for Colorectal and Lung Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that at least 21 days have passed since your last systemic therapy (like chemotherapy or radiation) before starting the study treatment. If you are currently on any investigational agents or immunosuppressive medications, you will need to stop those before participating.
What data supports the effectiveness of this treatment for colorectal and lung cancer?
The combination of durvalumab and tremelimumab has shown effectiveness in treating certain types of lung cancer and liver cancer, and studies suggest that adding radiotherapy could enhance the immune response against tumors. Additionally, durvalumab has been used successfully after radiotherapy in lung cancer patients, indicating potential benefits for combining these treatments.12345
Is the combination of durvalumab and tremelimumab with or without radiation therapy generally safe for humans?
The combination of durvalumab and tremelimumab has been studied in various cancers and is generally considered to have a tolerable safety profile, though it can lead to significant side effects. In studies, a notable percentage of patients experienced severe adverse events, such as reduced appetite and diarrhea, and when combined with chemotherapy, serious side effects like neutropenia (low white blood cell count) were common. The addition of radiotherapy is being explored for its potential to enhance treatment effects.14678
How is the drug combination of Durvalumab and Tremelimumab with radiation unique for treating colorectal and lung cancer?
Research Team
Jonathan D Schoenfeld
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
This trial is for adults with metastatic colorectal or non-small cell lung cancer who've had disease progression after prior therapy. They must have measurable disease, be in good physical condition (ECOG <=1), not pregnant, and willing to use birth control. Exclusions include recent chemotherapy, known allergies to trial drugs, uncontrolled illnesses, HIV-positive status, and certain previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tremelimumab and durvalumab with or without high or low-dose radiation therapy
Radiation
Participants receive high or low-dose radiation therapy starting at week 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Radiation Therapy
- Tremelimumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor