Study on Calderasib and Durvalumab for Treating Non-Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07554339

This clinical trial is exploring a new treatment combination of Calderasib and Durvalumab for people with locally advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed and has a specific KRAS G12C gene mutation. The study aims to see if this combination can help patients live longer without the cancer growing or spreading, compared to a placebo with Durvalumab.

Patient Parameters

Program Overview

Researchers are testing a new treatment for people with locally advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has a specific gene mutation called KRAS G12C. The study is investigating whether combining Calderasib, a new drug, with Durvalumab, an immunotherapy, can help control the cancer better after patients have already received chemotherapy and radiation therapy. The main goal is to find out if this combination helps patients live longer without the cancer getting worse, compared to those who receive a placebo with Durvalumab.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with locally advanced non-small cell lung cancer (NSCLC) that cannot be surgically removed, specifically Stage II (node-positive) to Stage III with mostly nonsquamous cells.
  • Completed a specific type of chemotherapy and radiation therapy without the cancer getting worse.
  • Provided a tumor sample for testing specific genetic markers, including KRAS G12C mutation and PD-L1 status.
  • Tumor sample shows the presence of KRAS G12C mutation and has a PD-L1 status that can be evaluated.
  • If living with HIV, must have well-controlled HIV with medication.
  • If positive for hepatitis B, must have an undetectable viral load and be on antiviral therapy.
  • If previously infected with hepatitis C, must have an undetectable viral load.
  • Weighs at least 35 kg (about 77 pounds).

Exclusion Criteria

  • Diagnosed with small cell lung cancer or tumors with small cell components.
  • Has digestive issues affecting medication absorption or cannot swallow pills.
  • Has active inflammatory bowel disease needing medication or a history of such disease.
  • Has uncontrolled heart or blood vessel disease.
  • Living with HIV and has a history of certain cancers like Kaposi's sarcoma.
  • Received other treatments for NSCLC besides the specified chemotherapy and radiation.
  • Has another cancer that is worsening or needed treatment in the last 3 years.
  • Has an active autoimmune disease needing treatment in the last 2 years.
  • Has a history of lung inflammation needing steroids.
  • Has an active infection needing treatment.
  • Has had a stem cell or organ transplant.
  • Has not fully recovered from major surgery or has ongoing surgical issues.

Locations

FACILITYZIPCITYSTATE
NHO Revive Research Institute LLC ( Site 0118)68506LincolnNebraska

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