Study on Daratumumab for Patients with STK11 Mutated Non-Small Cell Lung Cancer (NSCLC)

Sponsor: NYU Langone Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05807048

Provider View

This clinical trial is testing the effectiveness of the drug daratumumab in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called STK11/LKB1. Participants will have previously received standard treatments and will now receive daratumumab to see if it can help control their cancer.

Patient Parameters

Program Overview

This study is focused on patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic mutation known as STK11/LKB1. These patients have already tried standard treatments like chemotherapy, immunotherapy, and targeted therapy. In this trial, they will receive the drug daratumumab through injections under the skin. The treatment schedule involves weekly doses for the first 8 weeks, then every 2 weeks for the next 8 doses, and finally every 4 weeks until the cancer progresses. The study aims to see if at least 20% of patients show a positive response to the treatment, which would be considered significant.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and legally able to consent.
  • Must have confirmed advanced or inoperable non-small cell lung cancer (NSCLC).
  • Must have tried standard treatments like immunotherapy, chemotherapy, and targeted therapy, or be unable or unwilling to try them.
  • Must have a known STK11/LKB1 mutation confirmed by a certified lab.
  • Must have adequate organ and bone marrow function, including:
    • Hemoglobin level of at least 9 g/dL.
    • Neutrophil count of at least 1.5 x 10^9/L.
    • Platelet count of at least 75 x 10^9/L.
    • Liver enzymes (AST and ALT) no more than 3 times the normal limit.
    • Total bilirubin no more than 1.5 times the normal limit, unless they have Gilbert's syndrome.
    • Serum creatinine less than 1.5 times the normal limit or creatinine clearance over 50 mL/min.
  • Women must not be able to become pregnant or must use effective birth control during the study and for 6 months after.
  • Men must use condoms and ensure their partners use effective birth control during the study and for 6 months after.
  • Must agree to follow study rules and sign a consent form.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have uncontrolled health issues like severe high blood pressure, diabetes, or infections.
  • Require continuous oxygen therapy.
  • Have severe lung conditions like COPD with significant breathlessness.
  • Have moderate or severe asthma that is not controlled.
  • Have significant heart problems, such as recent heart attacks or severe heart failure.
  • Have had recent cancer treatments or unresolved side effects from previous treatments.
  • Have untreated brain metastases or active cancer in the brain.
  • Have other active cancers needing treatment or a history of cancer unless treated and resolved over 2 years ago.
  • Have allergies to daratumumab or its components.
  • Have active hepatitis B or C, or HIV.
  • Have had major surgery recently or plan to have surgery soon.
  • Have received live vaccines recently.

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