Study on Pembrolizumab with or without Chemotherapy for Stage IV Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT04165070

This clinical trial is testing the effectiveness and safety of pembrolizumab, with or without chemotherapy, combined with other investigational drugs, in patients with advanced non-small cell lung cancer (NSCLC) who have not received prior treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well pembrolizumab, a type of immunotherapy, works when used alone or with chemotherapy in combination with other investigational drugs like vibostolimab, boserolimab, and others. This study is for patients with advanced non-small cell lung cancer (NSCLC) who have not been treated before. It is part of a larger research program focused on pembrolizumab.

Description

This study is part of a larger research effort to understand the effects of pembrolizumab in treating advanced non-small cell lung cancer (NSCLC). Participants will receive pembrolizumab, with or without chemotherapy, along with other investigational drugs. The study aims to determine the safety and effectiveness of these combinations in shrinking tumors and improving patient outcomes. Participants will undergo various tests and procedures to monitor their health and the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage IV non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
  • Not eligible for approved targeted therapy if they have non-squamous NSCLC.
  • Able to provide a tumor tissue sample from a previous biopsy or a new biopsy taken within 90 days before starting treatment.
  • Have not received any prior systemic treatment for their metastatic NSCLC.
  • Able to complete all required screening procedures within the specified time frames.

Exclusion Criteria

  • Diagnosed with small cell lung cancer.
  • Have an immune system deficiency or are taking high doses of steroids or other immune-suppressing medications.
  • Have another active cancer that is progressing or required treatment in the past 2 years.
  • Have cancer that has spread to the brain or spinal cord.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation requiring steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • Have significant heart disease, such as recent heart attack or severe heart failure.
  • Have uncontrolled HIV, Hepatitis B, or Hepatitis C infections.
  • Have had major surgery within 3 weeks before starting the study treatment.
  • Need other cancer treatments while on the study.
  • Have digestive or liver conditions affecting medication absorption.
  • Have moderate nerve damage.
  • Have received certain cancer treatments or radiation therapy recently.
  • Have had severe allergic reactions to similar treatments.
  • Have had a tissue or organ transplant.

Locations

FACILITYZIPCITYSTATE
Banner MD Anderson Cancer Center ( Site 0001)85234GilbertArizona
City of Hope ( Site 0014)91010DuarteCalifornia
UCSF Medical Center at Mission Bay ( Site 0007)94158San FranciscoCalifornia
Georgetown University ( Site 0036)20007WashingtonDistrict of Columbia
University of Kentucky Markey Cancer Center ( Site 0019)40536-0293LexingtonKentucky
MedStar Franklin Square Medical Center ( Site 0033)21237BaltimoreMaryland
Massachusetts General Hospital ( Site 0003)02114BostonMassachusetts
Dana Farber Cancer Institute ( Site 0002)02215BostonMassachusetts
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)68130OmahaNebraska
Dartmouth Hitchcock Medical Center ( Site 0016)03766LebanonNew Hampshire

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.