Study of New Treatments for Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06780085

Provider View

This clinical trial is exploring new treatments for people with advanced nonsquamous non-small cell lung cancer (NSCLC) that has spread and been treated before. Researchers are testing two new antibody drug conjugates (ADCs) to see if they can help when standard treatments no longer work.

Patient Parameters

Program Overview

Researchers are investigating new ways to treat advanced nonsquamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has been treated before. Standard treatments include surgery followed by immunotherapy, with or without chemotherapy. However, these treatments may not work for everyone. This study is testing two new antibody drug conjugates (ADCs) to see if they can help treat NSCLC that hasn't responded to previous treatments. ADCs are designed to attach to cancer cells and deliver treatment directly to them. The study will compare these new treatments to chemotherapy to learn about their safety and effectiveness.

Description

The study, known as MK-3475-U01 (KEYMAKER-U01), is looking at two new treatments for people with advanced nonsquamous non-small cell lung cancer (NSCLC) that has already been treated. Researchers want to see if these new treatments, called antibody drug conjugates (ADCs), can help when standard treatments have stopped working. ADCs work by attaching to cancer cells and delivering treatment directly to them. The study will compare these new treatments to chemotherapy to see how safe they are and how well they work. Participants will be monitored to see how their cancer responds to the new treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Stage IV nonsquamous non-small cell lung cancer (NSCLC).
  • Cancer has progressed after receiving immunotherapy and platinum-based chemotherapy.
  • Cancer does not require specific treatments for certain genetic markers (EGFR-, ALK-, ROS1-).
  • Have measurable cancer as determined by medical scans.
  • Life expectancy of at least 3 months.
  • Good overall health with a performance status of 0 to 1.
  • At least 18 years old.
  • Have adequate organ function.
  • If capable of producing sperm, must use contraception or abstain from intercourse.
  • Women of childbearing potential must not be pregnant, must have a negative pregnancy test, and use effective contraception.
  • Provide a tumor sample from a new biopsy.
  • HIV-positive participants must have well-controlled HIV.
  • Participants with hepatitis B must have undetectable viral load after treatment.
  • Participants with a history of hepatitis C must have undetectable viral load.

Exclusion Criteria

  • Have small cell lung cancer or mixed tumors with small cell elements.
  • Have received radiation therapy to the lung.
  • Have uncontrolled heart problems.
  • Have severe lung issues from other illnesses.
  • Have not recovered from side effects of previous cancer treatments.
  • Have severe allergies to study treatments.
  • Have ongoing infections.
  • Have significant eye disease.
  • Have had recent radiation therapy or need steroids for radiation side effects.
  • Have not waited long enough after previous treatments.
  • Have received a live vaccine recently.
  • Have immune system issues or are on long-term steroids.
  • Have participated in another clinical trial recently.
  • Have another active cancer.
  • Have untreated brain cancer or meningitis.
  • Have lung disease that required steroids.
  • Have active autoimmune disease needing treatment.
  • Have active infections needing treatment.
  • Have HIV with certain complications.
  • Have inflammatory bowel disease needing treatment.
  • Have neurological issues related to cancer.
  • Have had an organ transplant.
  • Have not recovered from major surgery.

Locations

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

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