Niraparib + Dostarlimab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies the effect of niraparib and dostarlimab in treating small cell lung cancer and other high-grade neuroendocrine carcinomas. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may help to control the diseases.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on corticosteroids, you can continue as long as the dose is equivalent to 10 mg of prednisone or less and stable for at least 4 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
What makes the drug combination of Niraparib and Dostarlimab unique for treating small cell lung cancer?
The combination of Niraparib and Dostarlimab is unique because it targets cancer cells with DNA repair deficiencies, using Niraparib to increase DNA damage and Dostarlimab to enhance the immune response, potentially offering a new approach for small cell lung cancer that lacks standard treatments.12345
What data supports the effectiveness of the drug combination Niraparib and Dostarlimab for Small Cell Lung Cancer?
Dostarlimab has shown effectiveness in treating certain types of cancer, like endometrial cancer, by helping the immune system attack cancer cells. Niraparib has been studied as a maintenance treatment for small cell lung cancer, showing potential benefits in patients who responded to initial chemotherapy.13567
Who Is on the Research Team?
Carl Gay, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with small cell lung cancer or high-grade neuroendocrine carcinomas who've had at least one prior treatment can join. They must be generally healthy, not pregnant, and agree to contraception. Excluded are those with certain infections, recent major surgery, known allergies to trial drugs, brain metastases, autoimmune diseases requiring recent treatment, a second cancer within the last two years, or severe blood disorders from past treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib orally once daily on days 1-21 of cycles 1-4, and on days 1-42 of subsequent cycles. Dostarlimab is administered intravenously on day 1 of each cycle. Cycles repeat every 21 days for cycles 1-4 and every 42 days for subsequent cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs within 90 days post-treatment, every 6 months for 2 years, then annually for 3 years.
What Are the Treatments Tested in This Trial?
Interventions
- Dostarlimab
- Niraparib
Dostarlimab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor