Study Comparing JDQ443 and Docetaxel for Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT05132075

Provider View

This clinical trial is testing a new drug, JDQ443, against the standard chemotherapy drug, docetaxel, in patients with advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. The study aims to see which treatment is more effective after patients have already received chemotherapy and immunotherapy.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness and safety of a new drug, JDQ443, with the standard chemotherapy drug, docetaxel, in treating advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. This study is for patients who have already been treated with platinum-based chemotherapy and an immune checkpoint inhibitor. Participants will be randomly assigned to receive either JDQ443 or docetaxel. If the cancer progresses on docetaxel, participants may switch to JDQ443.

Description

This Phase III study is divided into two parts:

  • In the first part, participants will be randomly assigned to receive either JDQ443 or docetaxel to compare their effectiveness and safety. If the cancer progresses while on docetaxel, participants can switch to JDQ443.
  • In the second part, after analyzing the results, participants who were initially on docetaxel may switch to JDQ443, regardless of whether their cancer has progressed.

The study includes adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. Participants must have already received platinum-based chemotherapy and an immune checkpoint inhibitor. About 360 participants will be involved, with half receiving JDQ443 and half receiving docetaxel.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
  • Have received one prior platinum-based chemotherapy and one prior immune checkpoint inhibitor therapy.
  • Have at least one tumor that can be measured or evaluated by scans.

Exclusion Criteria

  • Have previously received docetaxel (unless it was before cancer progressed within 12 months of treatment) or any other KRAS G12C inhibitor.
  • Have certain other genetic mutations or rearrangements that affect treatment.
  • Have active cancer spread to the brain or spinal cord.
  • Have a history of certain lung diseases like interstitial lung disease or severe pneumonitis.

Locations

FACILITYZIPCITYSTATE
Valley Medical Center Research98055RentonWashington

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