Study on First-Line Treatment with Ipilimumab, Nivolumab, and Nogapendekin Alfa Inbakicept for Stage IV or Recurrent Non-Small Cell Lung Cancer

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT07355205

This clinical trial is testing a new combination of drugs, including ipilimumab, nivolumab, and nogapendekin alfa inbakicept, to see if they can work together to improve treatment for patients with advanced or returning non-small cell lung cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with advanced or recurrent non-small cell lung cancer (NSCLC). It combines two types of immune system-targeting drugs, ipilimumab and nivolumab, with a third drug called nogapendekin alfa inbakicept. The goal is to see if this combination can enhance the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or returning non-small cell lung cancer (NSCLC) that has not been treated before.
  • Be willing to provide a previous biopsy sample or undergo a new biopsy for testing.
  • Have measurable cancer according to specific medical criteria.
  • Be at least 18 years old.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function, as shown by specific blood test results.
  • If you have brain metastases, they must have been treated and stable for at least two weeks without needing high doses of steroids.
  • Agree to use effective birth control during the study and for six months after the last treatment dose if you can become pregnant or father a child.
  • Be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

  • Have a type of lung cancer that includes small cell lung cancer.
  • Have tumors with specific genetic mutations, such as EGFR, HER2, ALK, ROS1, RET, NTRK, MET, or BRAF mutations.
  • Have received live vaccines within 28 days before starting the study.
  • Have had chemotherapy or radiation therapy for lung cancer within the past 12 months, unless it was more than 12 months ago.
  • Have had major surgery within 14 days before starting the study.
  • Have certain medical conditions that could make the study treatment unsafe, such as lung disease, active infections, or significant heart problems.
  • Be taking high doses of steroids or other immune-suppressing medications.
  • Have HIV, hepatitis B, or hepatitis C infections that are not well-controlled.
  • Have a history of autoimmune diseases that required treatment in the past two years, except for certain conditions like vitiligo or resolved childhood asthma.
  • Have other active cancers that could interfere with the study.
  • Be pregnant or breastfeeding, or planning to become pregnant during the study.
  • Have a history of severe allergic reactions to similar drugs used in the study.

Locations

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

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