Study on Temozolomide and PARP Inhibitor for Treating Relapsed Small Cell Lung Cancer

Sponsor: VA Office of Research and Development

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06681220

Provider View

This clinical trial is testing a new treatment approach for patients with relapsed Small Cell Lung Cancer (SCLC) using a combination of Temozolomide and a PARP inhibitor. The study aims to see if certain biomarkers can predict who will benefit most from this treatment.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of two drugs, Temozolomide and a PARP inhibitor, can help treat patients with Small Cell Lung Cancer (SCLC) that has returned after initial treatment. Researchers are looking at specific biomarkers in the blood to see if they can predict which patients will respond best to this treatment. Participants will be divided into two groups based on their biomarker results. One group will receive the standard treatment with Lurbinectedin, while the other group will receive either the combination of Niraparib and Temozolomide or Lurbinectedin.

Description

This study is a phase 2 clinical trial conducted at multiple centers to evaluate the effectiveness of combining a PARP inhibitor with Temozolomide in patients with relapsed Small Cell Lung Cancer (SCLC). Researchers will test for two biomarkers in the blood, SLFN11 and MGMT, to identify patients who might respond well to this treatment. Patients who test positive for these biomarkers will be randomly assigned to receive either the combination of a PARP inhibitor and Temozolomide or Lurbinectedin. Those who test negative will receive Lurbinectedin as the standard treatment. The study aims to enroll 101 patients who test positive for the biomarkers and 51 patients who test negative. The goal is to determine if patients with positive biomarkers benefit more from the combination treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with extensive-stage Small Cell Lung Cancer (SCLC).
  • Must have received one prior line of systemic therapy, including Carboplatin and Etoposide.
  • May have received immunotherapy with chemotherapy.
  • Patients who received Tarlatamab as a second-line treatment are eligible.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have measurable disease according to specific criteria.
  • Must have adequate bone marrow, liver, and kidney function based on lab tests.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test before starting treatment.
  • Must agree to use effective birth control during the study and for a specified period after.
  • Patients with treated or asymptomatic brain metastases are allowed.

Exclusion Criteria

  • Have any unstable or serious medical condition, psychiatric illness, or social situation that could affect safety or compliance with the study.
  • Have a significant infection requiring treatment, unless it's a chronic infection under control.
  • Have previously been treated with Lurbinectedin, Temozolomide, or Niraparib.
  • Are pregnant or breastfeeding.
  • Have a known allergy to Niraparib or its components.
  • Have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Have high blood pressure that is not controlled.
  • Have a history of a specific brain condition called Posterior Reversible Encephalopathy Syndrome (PRES).

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