Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroe… (NCT04701307) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas
United States48 participantsStarted 2021-02-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must have unresected or locally advanced small cell lung cancer (Cohort 1) or high-grade neuroendocrine carcinoma (Cohort 2) confirmed by staff pathologist. High-grade neuroendocrine carcinoma of prostate (e.g. aggressive variant prostate cancer, small cell of prostate, etc.) are excluded
* Patients must have had at least one prior line of systemic therapy directed at their malignancy
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
* Participant must be \>= 18 years of age
* Absolute neutrophil count \>= 1,500/uL
* Platelets \>= 100,000/uL
* Hemoglobin \>= 9 g/dL
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \>= 60 mL/min using the Cockcroft-Gault equation
* Total bilirubin =\< 1.5 x ULN (=\< 2.0 in patients with known Gilberts syndrome) OR direct bilirubin =\< 1 x ULN
* Aspartate aminotransferase and alanine aminotransferase =\< 2.5 x ULN unless liver metastases are present, in which case they must be =\< 5 x ULN
* International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
* Participant…
What they're measuring
1
6-month Progression free survival (PFS)
Timeframe: Time from the start of study treatment to the earlier date of assessment of progression or death by any cause in the absence of progression, assessed at 6 months