Study on Niraparib and Dostarlimab for Treating Small Cell Lung Cancer and Other High-Grade Neuroendocrine Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04701307

Provider View

This clinical trial is exploring the effects of combining two drugs, niraparib and dostarlimab, to treat small cell lung cancer and other aggressive neuroendocrine cancers. Niraparib helps prevent cancer cells from repairing themselves, while dostarlimab boosts the immune system to attack cancer cells.

Patient Parameters

Program Overview

This study is testing whether the combination of niraparib, a targeted therapy, and dostarlimab, an immunotherapy, can effectively treat small cell lung cancer and other high-grade neuroendocrine carcinomas. Niraparib works by blocking an enzyme that cancer cells use to repair their DNA, potentially causing them to die. Dostarlimab helps the immune system recognize and attack cancer cells. The goal is to see if this combination can control the disease better than current treatments.

Description

The main goal of this study is to see how well the combination of niraparib and dostarlimab works in shrinking tumors and preventing cancer from getting worse for at least six months in patients with recurring small cell lung cancer and high-grade neuroendocrine carcinomas. Researchers will also look at the safety of this treatment and how long patients live after receiving it.

Patients will take niraparib by mouth daily for the first 21 days of each cycle for the first four cycles, and then for 42 days in later cycles. They will also receive dostarlimab through an IV on the first day of each cycle. The cycles repeat every 21 days initially and then every 42 days, as long as the treatment is working and side effects are manageable.

After finishing the treatment, patients will have follow-up visits within 90 days, then every six months for two years, and annually for three more years to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Have small cell lung cancer or high-grade neuroendocrine carcinoma that cannot be removed by surgery.
  • Have received at least one previous treatment for their cancer.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be 18 years or older.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 180 days after the last dose.
  • Men must agree to use effective contraception during the study and for 180 days after the last dose.
  • Agree not to donate blood during the study and for 90 days after the last dose.
  • Be able to understand the study and provide written informed consent.
  • HIV-positive patients can participate if they are on effective treatment with an undetectable viral load.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have previously received both a PARP inhibitor and immunotherapy together.
  • Have had major surgery within the last three weeks or investigational therapy within the last four weeks.
  • Have received radiation therapy affecting more than 20% of the bone marrow within two weeks, or any radiation therapy within one week before starting the study.
  • Have allergies to niraparib or dostarlimab.
  • Have received a blood transfusion or growth factors within the last four weeks.
  • Have a history of severe blood disorders or certain types of cancer within the last two years.
  • Have active, uncontrolled infections or serious medical conditions.
  • Have known brain metastases unless treated and stable.
  • Have had severe side effects from previous immunotherapy.
  • Have active hepatitis B or C, or an autoimmune disease requiring treatment in the past two years.
  • Have received a live vaccine within 14 days before starting the study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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