Study on Cisplatin-based Chemotherapy and Atezolizumab for Certain Stages of Resected Non-small Cell Lung Cancer (NSCLC) and Monitoring Circulating Tumor DNA

Sponsor: Nasser Hanna

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04367311

This clinical trial is exploring whether combining cisplatin-based chemotherapy with the immunotherapy drug atezolizumab can help prevent cancer recurrence in patients with certain stages of non-small cell lung cancer (NSCLC) after surgery. The study will also monitor circulating tumor DNA (ctDNA) to assess the risk of cancer returning.

Patient Parameters

Program Overview

This study aims to find out if using a combination of cisplatin-based chemotherapy and the immunotherapy drug atezolizumab can help reduce the chances of cancer coming back in patients with specific stages of non-small cell lung cancer (NSCLC) after surgery. Researchers will also track circulating tumor DNA (ctDNA) levels, as its presence after surgery is linked to a higher risk of cancer recurrence. The study focuses on patients with stage I (tumors 4cm or larger), IIA, IIB, and select stage III NSCLC who have detectable ctDNA after surgery.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to share personal health information.
  • Be 18 years or older.
  • Have a good performance status score of 0 or 1.
  • Have had complete surgical removal of stage I (tumors 4cm or larger), IIA, IIB, or select stage III NSCLC with no cancer left behind.
  • Have either squamous or non-squamous NSCLC.
  • Surgery must have been completed within 60 days before starting treatment.
  • Must have tissue samples available for testing.
  • Must have adequate organ function based on lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during treatment and for 5 months after.
  • Men must agree to use condoms or remain abstinent during treatment and for 5 months after.
  • Must be able to understand and follow study procedures.

Exclusion Criteria

  • Tumors with small cell or large cell neuroendocrine features are not eligible.
  • Tumors with specific genetic mutations (EGFR or ALK) are not eligible.
  • No prior chemotherapy, radiation, or immunotherapy for this lung cancer.
  • No other active cancers.
  • No history of certain diseases like leptomeningeal disease.
  • No prior treatment with certain immune therapies.
  • No recent live vaccines.
  • Not currently in another investigational study.
  • No immune deficiencies or chronic steroid use.
  • No severe allergies to atezolizumab.
  • No active autoimmune diseases.
  • No significant lung disease or pneumonitis.
  • No uncontrolled fluid buildup in the body.
  • No uncontrolled high calcium levels.
  • No recent significant heart disease.
  • No severe infections recently.
  • No history of HIV, active hepatitis B or C, or tuberculosis.
  • No prior organ transplants.
  • No conditions that could interfere with the study.
  • Not pregnant or breastfeeding.

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