Study Comparing Sotorasib and Durvalumab for Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06333678

Provider View

This clinical trial is exploring whether switching from durvalumab to sotorasib can better control locally advanced non-small cell lung cancer (LA-NSCLC) in patients with minimal residual disease (MRD) compared to continuing with durvalumab alone.

Patient Parameters

Program Overview

The study aims to find out if changing the treatment from durvalumab to sotorasib when minimal residual disease (MRD) is detected can help control locally advanced non-small cell lung cancer (LA-NSCLC) for a longer time. Researchers will compare this approach to continuing with durvalumab without switching to sotorasib.

Description

This study involves several phases:

  • Pre-Monitoring Phase: Patients with locally advanced non-small cell lung cancer (LA-NSCLC) and a specific KRAS G12C mutation are enrolled. They should be planning to undergo, currently undergoing, or have recently completed chemoradiation therapy, with plans to start durvalumab consolidation. During this phase, patients receive standard care treatment.

  • Monitoring Phase: Patients who have completed chemoradiation, have detectable cancer DNA in their blood, and show no signs of disease progression on scans will continue to this phase. They will start durvalumab consolidation and have their cancer DNA levels checked again.

  • Randomization Phase: Patients with minimal residual disease (MRD) will be randomly assigned to either continue with durvalumab or switch to sotorasib. Those switching to sotorasib will stop durvalumab for 28 days before starting sotorasib at a dose of 960 mg daily. The main goal is to see which treatment helps patients live longer without the cancer getting worse.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC) that is locally advanced (Stage III).
  • Planning to undergo, currently receiving, or recently completed chemoradiation therapy with specific chemotherapy regimens.
  • Have a KRAS G12C mutation.
  • Good liver function.
  • Eligible for durvalumab therapy.
  • ECOG performance status of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Aged 18 years or older.
  • Able to consent to the study.
  • Women must be non-reproductive or agree to use contraception.

Monitoring Phase

  • Completed chemoradiation therapy.
  • Detectable cancer DNA in the blood within 8 weeks of completing chemoradiation.
  • No signs of disease progression on scans.
  • Plan to start durvalumab consolidation.

Therapeutic Phase

  • No signs of disease progression on scans.
  • Minimal residual disease (MRD) detected.
  • Eligible for sotorasib therapy.
  • Negative pregnancy test before starting sotorasib (if applicable).

Exclusion Criteria

  • Serious medical conditions that prevent radiotherapy.
  • Pregnant or breastfeeding women.
  • Physical limitations that prevent radiotherapy.
  • Other active cancers within the last year, except for certain skin cancers and localized bladder cancer.
  • History of lung inflammation (pneumonitis).

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.