Study on New Treatments for Previously Treated Stage IV Squamous Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06780098

Provider View

This clinical trial is exploring new treatments for patients with Stage IV squamous non-small cell lung cancer (NSCLC) that has spread and did not respond to standard treatments. The study focuses on antibody drug conjugates (ADCs) to see if they can effectively treat this type of cancer.

Patient Parameters

Program Overview

Researchers are investigating new ways to treat metastatic squamous non-small cell lung cancer (NSCLC), which is a type of lung cancer that starts in the flat cells lining the airways and has spread to other parts of the body. The usual treatment involves immunotherapy, sometimes combined with chemotherapy, but these may not always work. This study is testing new treatments called antibody drug conjugates (ADCs) to see if they can help when standard treatments have failed. ADCs work by attaching to proteins on cancer cells and delivering drugs to destroy them. The main goals are to compare how well these new treatments work against chemotherapy and to check their safety and tolerability.

Description

This study is part of a larger research effort under a master protocol called MK-3475-U01 (KEYMAKER-U01). The study is looking at new treatments for Stage IV squamous non-small cell lung cancer (NSCLC) that has not responded to standard treatments. The focus is on antibody drug conjugates (ADCs), which are designed to target and destroy cancer cells more effectively. Researchers want to see if these ADCs can provide better outcomes than chemotherapy and to ensure they are safe for patients to use. The study is open to participants who meet specific criteria and aims to provide new insights into treating this challenging form of lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC).
  • Cancer must have progressed after receiving immunotherapy and platinum-based chemotherapy.
  • If HIV-positive, must have well-controlled HIV on antiretroviral therapy.
  • If positive for Hepatitis B, must have been on antiviral therapy for at least 4 weeks with undetectable viral load.
  • If previously infected with Hepatitis C, must have an undetectable viral load.

Exclusion Criteria

  • Have small cell lung cancer or mixed tumors with small cell elements.
  • Have uncontrolled or serious heart problems.
  • Have severe lung issues from other illnesses, such as recent blood clots in the lungs, severe asthma, or chronic lung diseases.
  • Have not recovered from side effects of previous cancer treatments, except for hair loss.
  • Have ongoing uncontrolled infections, including HIV.
  • Have serious eye diseases affecting the cornea.
  • Have another active cancer that is progressing or needed treatment in the last 3 years.
  • Have untreated cancer spread to the brain or spinal fluid.
  • Have a history of lung inflammation that needed steroids or have current lung inflammation.
  • Have an active autoimmune disease needing treatment in the last 2 years, except for replacement therapies like thyroid or insulin.
  • Have an active infection needing treatment.
  • Have HIV with a history of certain related diseases.
  • Have active inflammatory bowel disease needing immunosuppressive medication.
  • Have a history of certain neurological conditions related to cancer.
  • Have had a tissue or organ transplant.
  • Have not fully recovered from major surgery or have ongoing surgical issues.

Locations

FACILITYZIPCITYSTATE
University of Kentucky Chandler Medical Center ( Site 0019)40536-0293LexingtonKentucky
MedStar Franklin Square Medical Center ( Site 0033)21237BaltimoreMaryland

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