Niraparib + Dostarlimab for Small Cell Lung Cancer

Palo Alto (17 mi)

Overseen byCarl Gay, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Eligibility Criteria

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

I am over 45 and have not had a period for more than a year.

I have received at least one treatment for my cancer.

I am 18 years old or older.

My kidney function, measured by creatinine levels, is within the normal range.

I have received radiation therapy to my pelvic area.

I have either advanced small cell lung cancer or high-grade neuroendocrine carcinoma.

I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

I have never been diagnosed with MDS or AML.

I have never been treated with both PARP inhibitors and immunotherapy at the same time.

I haven't had any cancer other than skin or treated cervical cancer in the last 2 years.

I have never had interstitial lung disease.

I haven't had significant radiation therapy affecting my bone marrow recently.

I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

I do not have any serious health issues that are not under control.

I have active hepatitis B or C.

I am not allergic to niraparib or dostarlimab.

I have not received a live vaccine in the last 14 days.

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

I had a severe reaction to previous immunotherapy.

Treatment Details

The trial is testing niraparib (a PARP inhibitor that blocks cancer cells' DNA repair) combined with dostarlimab (an immunotherapy antibody). It's for patients whose disease didn't respond well to initial treatments. The study aims to see if this combination helps control the disease better than existing therapies.

1Treatment groups

Experimental Treatment

Group I: Treatment (niraparib, dostarlimab)Experimental Treatment2 Interventions

Patients receive niraparib PO QD on days 1-21 of cycles 1-4, and on days 1-42 of subsequent cycles. Patients also receive dostarlimab IV over 30 minutes on day 1. Cycles repeat every 21 days for cycles 1-4 and every 42 days for subsequent cycles in the absence of disease progression or unacceptable toxicity.

Dostarlimab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Jemperli for:

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

🇺🇸 Approved in United States as Jemperli for:

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