Study on Petosemtamab for Adults with Metastatic Non-Small Cell Lung Cancer

Sponsor: Merus B.V.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07353957

Provider View

This clinical trial is testing the effectiveness and safety of a new drug, petosemtamab, combined with Pembrolizumab, for treating adults with advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug petosemtamab works when used with Pembrolizumab in adults who have advanced non-small cell lung cancer (NSCLC). The study focuses on two types of NSCLC: squamous and non-squamous. Researchers aim to determine if this combination can effectively treat the cancer and ensure it is safe for patients.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form and agree to follow all study procedures.
  • Must be 18 years or older.
  • Must have at least one tumor that can be measured by scans.
  • Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a life expectancy of at least 12 weeks.
  • Must have good blood, kidney, and liver function as determined by specific tests.
  • Must have a serum albumin level of at least 3 g/dL.
  • Must have normal magnesium and calcium levels.
  • Women and men of childbearing potential must agree to use effective birth control during the study.
  • Must have confirmed advanced (Stage IV) squamous or non-squamous NSCLC with a PD-L1 score of 50% or higher.
  • Must not have received any prior treatment for advanced NSCLC.
  • Must have testing to confirm no actionable genetic changes in the tumor.

Exclusion Criteria

  • Have untreated cancer spread to the brain or spinal fluid.
  • Have participated in another clinical trial with an investigational drug within 4 weeks before starting this study.
  • Have previously received treatment with a PD-(L)1 inhibitor.
  • Have received chemotherapy or other cancer treatments for advanced NSCLC before.
  • Have had any cancer treatment within 4 weeks before starting this study.
  • Have had major surgery or radiation therapy within 3 weeks before starting this study.
  • Have ongoing side effects from previous cancer treatments that are more than mild.
  • Have allergies to any ingredients in petosemtamab or pembrolizumab.
  • Have serious heart conditions, such as unstable angina or recent heart attack.
  • Have had another cancer in the last 5 years, except for certain local cancers that were removed.
  • Have difficulty breathing at rest or need continuous oxygen therapy.
  • Have serious illnesses or medical conditions, including uncontrolled infections or significant lung, metabolic, or mental health disorders.
  • Have known infectious diseases.
  • Are pregnant or breastfeeding.

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