Study on Niraparib, Temozolomide, and Atezolizumab for Treating Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03830918

Provider View

This clinical trial is exploring a combination of drugs—niraparib, temozolomide, and atezolizumab—to see if they can effectively treat advanced solid tumors and extensive-stage small cell lung cancer in patients who have responded to initial chemotherapy.

Patient Parameters

Program Overview

This study is testing a combination of three drugs: niraparib, temozolomide, and atezolizumab, to see if they can help treat advanced solid tumors and extensive-stage small cell lung cancer (ES-SCLC) in patients who have shown a complete or partial response to initial platinum-based chemotherapy. Temozolomide is a chemotherapy drug that stops cancer cells from growing, while niraparib is a targeted therapy that prevents cancer cells from repairing their DNA. Atezolizumab is an immunotherapy that helps the immune system attack cancer cells. The study aims to find the best dose of temozolomide and evaluate how well this combination works compared to atezolizumab alone.

Description

The study has two main parts: Phase Ib and Phase II.

In Phase Ib, researchers will determine the best dose of temozolomide when used with niraparib and atezolizumab. In Phase II, they will compare the effectiveness of the combination of niraparib, temozolomide, and atezolizumab against atezolizumab alone by looking at how long patients live without the cancer getting worse (progression-free survival).

Secondary goals include comparing overall survival rates and response rates between the two treatment groups, as well as evaluating the safety of the drug combination. Researchers will also collect information on patients' quality of life and any side effects they experience.

Participants will be randomly assigned to one of two groups:

  • Group A: Receives temozolomide and niraparib daily, along with atezolizumab every three weeks.
  • Group B: Receives atezolizumab every three weeks.

After finishing the study treatment, participants will have follow-up visits to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to provide informed consent.
  • Have a confirmed diagnosis of advanced and incurable solid cancer.
  • For Phase 1b, must have a cancer type for which atezolizumab is FDA-approved.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Able to swallow study drugs and comply with study requirements.
  • Meet specific blood count and organ function criteria.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 180 days after.
  • Male participants must use a condom during sex with women of childbearing potential during the study and for 180 days after.
  • Agree not to donate blood, sperm, or eggs during the study and for a specified period after.
  • For Phase 2, must have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and have responded to initial chemotherapy.
  • Able to start the study within 7 weeks after the last chemotherapy cycle.

Exclusion Criteria

  • Have not fully recovered from side effects of previous treatments.
  • Have used other cancer treatments or investigational drugs recently.
  • Have untreated or symptomatic brain metastases.
  • Have serious health conditions or impaired organ function.
  • Have a history of certain blood disorders or other cancers within the last 3 years.
  • Have gastrointestinal disorders affecting drug absorption.
  • Are considered a poor medical risk due to uncontrolled health issues.
  • Are pregnant or breastfeeding.
  • Have previously used a PARP inhibitor (except iniparib) for Phase 2.
  • Must continue maintenance atezolizumab if started during initial treatment for ES-SCLC.

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