Study on Pembrolizumab for Advanced Non-Small Cell Lung Cancer (NSCLC) with Performance Status 2-3

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05589818

Provider View

This clinical trial is testing the effects of pembrolizumab, an immunotherapy drug, on quality of life in patients with advanced non-small cell lung cancer (NSCLC) who cannot undergo surgery or intensive treatments. The study focuses on patients with a performance status of 2 or 3, indicating some limitations in daily activities.

Patient Parameters

Program Overview

This study is designed to see if pembrolizumab, given every three weeks, can improve the quality of life for patients with advanced non-small cell lung cancer (NSCLC) who are not eligible for surgery or intensive treatments. The trial will include 45 patients and will measure changes in quality of life over 12 weeks. Patients will also have regular health assessments and scans to monitor their condition.

Description

The main goal of this study is to understand how pembrolizumab affects the quality of life in patients with advanced non-small cell lung cancer (NSCLC) who cannot receive standard treatments due to their health status. Pembrolizumab is given as an infusion every three weeks, and the study will track changes in patients' quality of life over 12 weeks.

Secondary goals include evaluating the overall health outcomes, side effects, and emotional well-being of patients receiving pembrolizumab. The study will also look at how different factors like age, gender, and other health conditions affect treatment outcomes.

Patients will receive pembrolizumab for 12 weeks, with the option to continue treatment if it is beneficial. The study will take place at Mount Sinai Hospital and Mount Sinai Chelsea, with an expected enrollment period of 24 months and a total study duration of 40 months.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or intensive treatments.
  • Patients must not have received any previous treatment for metastatic cancer.
  • Patients must not have received any PD-1 or PD-L1 inhibitors.
  • Performance status of 2 or 3, indicating some limitations in daily activities.
  • No specific genetic mutations that have approved targeted therapies.
  • Patients with treated brain metastases are eligible if stable for at least 4 weeks.
  • Patients with HIV on effective treatment with undetectable viral load are eligible.
  • Adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 4 months after.
  • Men must agree to use condoms or other effective contraception methods during the study.
  • Ability to understand and sign informed consent and comply with study procedures.

Exclusion Criteria

  • Autoimmune conditions requiring high doses of steroids or other immunosuppressive treatments.
  • Participation in other investigational drug studies.
  • Uncontrolled illnesses such as active infections, heart failure, or psychiatric conditions that could interfere with the study.
  • Known leptomeningeal disease requiring treatment.
  • Pregnant or breastfeeding women.

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