Study on Combining Cabozantinib and Atezolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Jun Zhang, MD, PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05859217

Provider View

This clinical trial is exploring a new treatment combination of cabozantinib and atezolizumab for patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have low levels of a protein called PD-L1. The study aims to see if this combination can provide better treatment outcomes.

Patient Parameters

Program Overview

The study is designed to test if combining cabozantinib, a drug that targets multiple pathways in cancer cells, with atezolizumab, an immunotherapy drug, can improve treatment results for patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have low PD-L1 levels. These patients typically do not respond well to current immunotherapy treatments alone. Researchers believe that cabozantinib may help create a more favorable environment for the immune system to attack cancer cells, potentially leading to better outcomes when used with atezolizumab.

Description

This study focuses on patients with advanced or metastatic non-small cell lung cancer (NSCLC) who do not have specific mutations that can be targeted with existing treatments. Currently, these patients often receive a combination of chemotherapy and immunotherapy, but those with low levels of the PD-L1 protein (less than 1%) do not respond as well to these treatments. The study aims to find out if adding cabozantinib to atezolizumab can improve treatment effectiveness.

Cabozantinib is known to target several pathways that help cancer cells grow and spread, including the VEGF pathway, which can suppress the immune system's ability to fight cancer. By blocking these pathways, cabozantinib may enhance the immune response against cancer cells. Previous studies have shown that cabozantinib can increase the presence of immune cells that attack tumors and reduce cells that suppress the immune response.

The study will use this combination as a first-line treatment for patients with advanced or metastatic NSCLC who have low PD-L1 levels, to see if it can improve outcomes compared to current standard treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand the study and sign a consent form.
  • Men and women aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Diagnosed with advanced or metastatic NSCLC with low PD-L1 levels (less than 1%).
  • Have at least one tumor that can be measured by scans.
  • Have not received prior systemic treatment for NSCLC, unless they have specific mutations and have already tried targeted therapies.
  • Must provide a tumor sample for research purposes.
  • Must have recovered from any side effects of previous treatments.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for six months after.
  • Men must agree not to father a child or donate sperm during the study and for six months after.
  • Must have adequate organ function and negative tests for HIV, hepatitis B, and hepatitis C, unless these conditions are well-controlled.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Using other investigational drugs.
  • Have had a psychiatric or social condition that would interfere with the study.
  • Have an active infection or have had a severe infection recently.
  • Have specific mutations and have not tried targeted therapies.
  • Have cancer that has spread to the brain or spinal cord unless treated and stable.
  • Have had major surgery recently or have not healed from surgery.
  • Have another cancer that could affect the study results.
  • Have previously been treated with cabozantinib or atezolizumab.
  • Have received certain cancer treatments recently.
  • Have uncontrolled heart conditions or significant bleeding issues.
  • Have autoimmune diseases or immune deficiencies.
  • Are pregnant or breastfeeding.
  • Cannot swallow tablets or have allergies to study drugs.
  • Have uncontrolled pain or fluid buildup in the body.
  • Have had severe infections or are taking certain medications that affect the immune system.

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