Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.

Trial Details

NCT ID
NCT05398094
Phase
PHASE2
Sponsor
Fundación GECP
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Sotorasib
Locations (sample)
  • Alicante, Alicante, Spain|38.34517,-0.48149
  • Badalona, Barcelona, Spain|41.45004,2.24741
  • Barcelona, Barcelona, Spain|41.38879,2.15899
  • Barcelona, Barcelona, Spain|41.38879,2.15899
  • Barcelona, Barcelona, Spain|41.38879,2.15899

Key Eligibility Criteria

  • 1\. Male or female, aged ≤ 80 years old
  • 2\. ECOG performance status of 0-1
  • 3\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International …
  • 4\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.

For full eligibility, visit ClinicalTrials.gov.

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