Study on Maintenance Treatment with Cabozantinib and Pembrolizumab for Patients with Advanced Squamous Non-Small Cell Lung Cancer

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05613413

Provider View

This clinical trial is exploring the effectiveness and safety of using a combination of cabozantinib and pembrolizumab as ongoing treatment for patients with advanced squamous non-small cell lung cancer (sqNSCLC) who have already received initial therapy.

Patient Parameters

Program Overview

The study aims to evaluate how well the combination of cabozantinib and pembrolizumab works as a maintenance treatment for patients with advanced squamous non-small cell lung cancer (sqNSCLC) who have already undergone four cycles of initial therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel. The focus is on patients who have shown disease control, meaning their cancer has either shrunk, remained stable, or completely responded to the initial treatment.

Description

This clinical trial is designed to test the effectiveness and safety of a combination of two drugs, cabozantinib and pembrolizumab, as a maintenance treatment for patients with advanced squamous non-small cell lung cancer (sqNSCLC). Patients eligible for this study are those who have already received four cycles of initial treatment with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel, and have shown disease control, which means their cancer has either shrunk, remained stable, or completely responded to the initial treatment.

Participants will continue with the maintenance therapy using cabozantinib and pembrolizumab to see if it helps keep the cancer under control. The study will also look at the impact of this treatment on patients' quality of life and monitor any side effects.

The trial is open to adults aged 18 and older who meet specific health criteria, including having a confirmed diagnosis of squamous non-small cell lung cancer and adequate organ function. Participants must also agree to use effective contraception during the study and for a period after the treatment ends.

The study will exclude individuals with certain health conditions, such as active infections, previous treatment with cabozantinib, or other recent cancer therapies. Pregnant or breastfeeding women are also not eligible to participate.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent and authorization for the release of personal health information.
  • Must be 18 years or older.
  • Must have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Must have a life expectancy of at least 6 months.
  • Must have a confirmed diagnosis of squamous non-small cell lung cancer (sqNSCLC).
  • Must have stage IV NSCLC and not have received prior therapy for this stage.
  • Must have shown disease control (complete response, partial response, or stable disease) after initial therapy.
  • Tumors must have been tested for PD-L1 expression.
  • Must have adequate organ function based on specific lab tests.
  • Must have recovered from any side effects of previous treatments.
  • Must agree to use effective contraception during the study and for 4 months after the last dose of cabozantinib and pembrolizumab.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Must be able to understand and comply with the study requirements and have signed the informed consent document.
  • Must be willing to attend scheduled visits and follow the treatment plan.

Exclusion Criteria

  • Have an active infection requiring treatment.
  • Are pregnant or breastfeeding.
  • Have previously been treated with cabozantinib.
  • Have received certain cancer treatments recently.
  • Have had recent radiation therapy.
  • Have cancer invading major blood vessels or certain lung lesions.
  • Have targetable genetic mutations with available treatments.
  • Have uncontrolled or significant health issues, such as heart problems or gastrointestinal disorders.
  • Have had significant bleeding or brain metastases unless treated and stable.
  • Are taking certain blood thinners or have received a live vaccine recently.
  • Have a history of severe allergic reactions to study drugs.
  • Have another active cancer or have had one recently.
  • Have had major surgery recently.
  • Have received a solid organ or stem cell transplant.
  • Have a known allergy to cabozantinib.
  • Are unable to swallow tablets or receive IV treatment.
  • Have a prolonged QT interval on an ECG.
  • Have any condition that may increase the risk of study participation or interfere with the study.

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