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

NCT05398094 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Non-small Cell Lung Cancer Stage III
  • KRAS P.G12C

Interventions

DRUG

Sotorasib

AMG510 (Sotorasib) is small molecule that specifically and irreversibly inhibits the KRAS-G12C mutant protein. AMG510 (Sotorasib) finished product is presented as tablets containing 120mg and will be packaged in bottles of 120 tablets.

Sponsors & Collaborators

  • Fundación GECP

    lead OTHER

Principal Investigators

  • Mariano Provencio, MD · Fundación GECP President

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05398094 on ClinicalTrials.gov