Study on Carboplatin, Pemetrexed, and Atezolizumab for Non-squamous Non-small Cell Lung Cancer with Untreated Brain Metastases

Sponsor: Liza Villaruz, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05746481

Provider View

This clinical trial is testing a combination of drugs, including tiragolumab, carboplatin, pemetrexed, and atezolizumab, to see if they are safe and effective for treating non-squamous non-small cell lung cancer (NSCLC) that has spread to the brain but hasn't been treated yet.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a drug combination including tiragolumab, carboplatin, pemetrexed, and atezolizumab for patients with non-squamous non-small cell lung cancer (NSCLC) that has spread to the brain and hasn't been treated yet. Patients will undergo brain scans and other tests to monitor their response to the treatment.

Description

This phase II clinical trial is designed to test the safety and effectiveness of a combination of drugs—tiragolumab, carboplatin, pemetrexed, and atezolizumab—in treating patients with non-squamous non-small cell lung cancer (NSCLC) that has spread to the brain but hasn't been treated yet. Participants must have at least one brain tumor that is 5 mm or larger and hasn't been treated. They will have a brain MRI three weeks into the treatment for safety checks, and additional evaluations every nine weeks. The study will also measure a specific protein in the tumor to help understand the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed non-squamous NSCLC.
  • Must have brain metastases that are not causing symptoms, with at least one untreated brain tumor 5 mm or larger.
  • Previous treatments for early-stage lung cancer are allowed if completed over a year ago.
  • Previous radiation for symptom relief in other areas is allowed.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a life expectancy of at least 12 weeks.
  • Must have normal organ and bone marrow function, as shown by specific blood tests.
  • Must not have a history of HIV, unless well-controlled with treatment.
  • Must test negative for hepatitis B and C, or have these conditions under control.
  • Must provide a tumor sample for research.
  • Women of childbearing potential must agree to use effective contraception during and after treatment.
  • Men must agree to use contraception and not donate sperm during and after treatment.
  • Women must have a negative pregnancy test before starting treatment.
  • Must understand and agree to the study requirements.

Exclusion Criteria

  • Symptoms from brain metastases needing treatment within two weeks before starting the study.
  • Previous treatment for metastatic disease is not allowed.
  • Tumors with specific genetic changes that have approved treatments are excluded.
  • Currently taking other experimental drugs.
  • History of autoimmune diseases or immune deficiencies, with some exceptions.
  • History of lung diseases like pulmonary fibrosis or pneumonitis.
  • History of leptomeningeal disease or active tuberculosis.
  • Recent significant heart problems or major surgery.
  • Recent severe infections or other cancers within two years, with some exceptions.
  • Previous organ transplants.
  • Conditions that could interfere with the study or increase risk.
  • Recent live vaccines or need for such vaccines during the study.
  • Recent use of high-dose steroids or other immune-suppressing drugs, with some exceptions.
  • Allergies to study drugs or similar compounds.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or after the study.

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