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Recruiting Phase 2 NCT05631249

Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

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Trial Parameters

Condition KRAS P.G12C
Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-12-13
Completion 2027-12-12
Interventions
Sotorasib 120Mg Tab

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Brief Summary

This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.

Eligibility Criteria

Inclusion Criteria: * Age higher than 18 years; * ECOG less or equal to 1 at the time of screening; * Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted); * Subjects will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. * Life expectancy of longer than 3 months from the time of screening, in the opinion of the investigator; * Patients must have lesions easily accessible to biopsy and must have accepted to perform pre-treatment, on-treatment and end-of-treatment biopsies; * Have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to registration * Patients must understand, sign and date the written informed consent from prior to any protocol-specific procedur

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