Niraparib + Dostarlimab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial tests two drugs, niraparib and dostarlimab, to evaluate their combined effectiveness against small cell lung cancer and high-grade neuroendocrine carcinomas. Niraparib prevents cancer cells from repairing damaged DNA, potentially leading to cell death, while dostarlimab, an immunotherapy drug, aids the immune system in attacking the cancer. This trial may suit individuals with small cell lung cancer or certain neuroendocrine cancers who have previously tried at least one other treatment. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of niraparib and dostarlimab is generally well-tolerated by patients. Previous studies have found that these treatments can help slow the growth or spread of cancers, such as ovarian cancer.
Patients commonly report side effects like tiredness, nausea, and low blood cell counts. However, these side effects are usually manageable, and doctors closely monitor them during treatment.
Since researchers have studied niraparib and dostarlimab in different types of cancer, there is substantial evidence that they are relatively safe when used together. It is important to remember that everyone reacts differently, and healthcare providers will ensure patient safety and address any concerns.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatment combination of niraparib and dostarlimab for small cell lung cancer because it offers a new approach to tackling this aggressive disease. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, dostarlimab is an immunotherapy that helps the body's immune system recognize and fight cancer cells. Niraparib, a PARP inhibitor, works by preventing cancer cells from repairing their DNA, leading to their death. This dual-action strategy could potentially improve outcomes by both enhancing immune response and directly targeting cancer cell survival mechanisms.
What evidence suggests that niraparib and dostarlimab could be effective for small cell lung cancer?
Research shows that using niraparib and dostarlimab together might help treat small cell lung cancer. In this trial, participants will receive both niraparib and dostarlimab. Niraparib blocks a protein that repairs damaged DNA in cells. When cancer cells can't repair their DNA, they may die. Dostarlimab helps the immune system attack cancer cells, potentially stopping their growth and spread. Previous studies with similar treatments have shown positive results in other types of cancer, suggesting these drugs could work well together. While data collection for small cell lung cancer continues, the science behind these drugs supports their potential effectiveness.12678
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:
- Mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
- dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen
- Adults with dMMR recurrent or advanced solid tumors who have progressed on or following prior treatment and lack satisfactory alternative treatment options
- Primary advanced or recurrent dMMR endometrial cancer in combination with carboplatin and paclitaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor