RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC (LungKG12Ci)

Intergroupe Francophone de Cancerologie Thoracique

Status: Active, not recruiting

Conditions: Nsclc; KRAS P.G12C

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05273047

IFCT-2102

Details and patient eligibility

About

The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.

Full description

The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.

The objective of this retrospective observational, multicenter, cohort study is to describe, in real life, the characteristics and evolution of NSCLC patients with a KRAS G12C mutation, treated with sotorasib in the framework of the cohort ATU in France.

Enrollment: 458 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Stage IV NSCLC at time of initiation of treatment with sotorasib
• Presence of KRAS G12C mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed)
• Patients who received at least one dose of the treatment with sotorasib as part of the French Early Access Program (ATU program)
• Patients who were informed about the study and do not object for their data to be collected
• Age > 18 years

Exclusion criteria

• Patients enrolled in a sotorasib clinical trial
• Patients with a psychiatric history that hinders the comprehension of the information leaflet
• Patients under curatorship or guardianship
• Unable to obtain data collection