RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment and Follow-up of Patients With KRAS G12C-mutated Metastatic Non-Small Cell Lung Cancer Who Received Sotorasib as Part of the French Early Access Program (ATU)

Conditions
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Nsclc, KRAS P.G12C

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world progression-free survival (rwPFS) | rwPFS will be defined as the time from the date of the first dose of treatment with sotorasib to the date of first occurrence of disease progression (defined by the treating physician) or death from any cause during the study | through study completion, an average of 1.5 year | 
| Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib | Stage cTNM, smoking habits, PS, presence of brain metastasis, gender, age, histological, KRAS and other biomarkers status | 6 months | 
| Overall survival (OS) | OS will be determined as the time from the date of first dose of treatment with sotorasib to the date of death due to any cause during the study | through study completion, an average of 1.5 year | 
| Duration of treatment with sotorasib | Duration of treatment is defined as the time from the date of first dose of treatment with sotorasib to the date of discontinuation of treatment with sotorasib or death from any cause during the study | through study completion, an average of 1.5 year | 
| Best response (complete response, partial response, stable disease, progression) | Best response will be defined as the best response recorded from the start of treatment with sotorasib until disease progression or start of further anti-cancer treatment | through study completion, an average of 1.5 year | 
| Duration of response | Duration of response will be defined as the time from the date of the first documented response (complete or partial) to the earliest date of disease progression | through study completion, an average of 1.5 year | 
| Duration of treatment with sotorasib beyond 1rst progression | Duration of treatment with sotorasib beyond progression will be defined as time between first occurrence of disease progression and treatment discontinuation | through study completion, an average of 1.5 year | 
| Description of treatments received before and after sotorasib treatment | Description of treatments received before and after sotorasib treatment | through study completion, an average of 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sotorasib, real-world study, KRAS P.G12C, NSCLC, IFCT