Study on Stereotactic Body Radiation Therapy With or Without Nivolumab for Stage I-IIA or Recurrent Non-small Cell Lung Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT03110978
This clinical trial is exploring whether adding the immunotherapy drug nivolumab to stereotactic body radiation therapy can improve treatment outcomes for patients with early-stage or returning non-small cell lung cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is investigating how well a precise form of radiation therapy, called stereotactic body radiation therapy (SBRT), works on its own or when combined with the immunotherapy drug nivolumab in treating patients with early-stage or recurrent non-small cell lung cancer (NSCLC). SBRT uses advanced technology to target tumors with high precision, potentially reducing the number of treatments needed and minimizing damage to healthy tissue. Nivolumab is an immunotherapy drug that may help the immune system attack cancer cells and prevent them from growing and spreading. The study aims to determine if combining SBRT with nivolumab is more effective than SBRT alone.
Description
The main goal of this study is to see how long patients can live without their cancer returning or spreading. Researchers will also look at overall survival rates and any side effects from the treatments. They will explore potential markers that might predict how well patients respond to the treatment.
Participants will be randomly assigned to one of two groups:
- Group 1 will receive stereotactic body radiation therapy (SBRT) over 1-2 weeks.
- Group 2 will receive SBRT over 1-2 weeks and also receive nivolumab through an IV infusion around the same time. Nivolumab treatments will continue every 4 weeks for up to 12 weeks, as long as the cancer does not progress and side effects are manageable.
After completing the study treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for up to 3 years, and annually after that.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) through a biopsy or similar test.
- Cancer must be at stage I or selected stage IIA, meaning it is relatively small and has not spread to lymph nodes or other parts of the body.
- Patients with multiple primary lung tumors or recurrent NSCLC that can be treated with SBRT are eligible.
- Tumors should be 7 cm or smaller and not involve critical structures like the esophagus or heart.
- Must have completed any previous cancer treatments at least 12 weeks before starting the study.
- Must have good overall health with a performance status score of 0-2.
- Must agree to use effective birth control during the study and for a specified time after treatment.
- Must meet specific blood count and organ function criteria based on recent tests.
Exclusion Criteria
- Tumors larger than 7 cm or involving critical structures are not eligible.
- Patients with evidence of cancer spread beyond the lungs or with other recent cancers are not eligible.
- Patients who have previously received certain types of immunotherapy are not eligible.
- Patients planning to receive other cancer treatments during the study are not eligible.
- Pregnant or breastfeeding women are not eligible.
- Patients with active autoimmune diseases or requiring high doses of steroids are not eligible.
- Patients with certain infections or allergies to study drugs are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MD Anderson in The Woodlands | 77384 | Conroe | Texas |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
| MD Anderson West Houston | 77079 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.