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

Sponsor

Intergroupe Francophone de Cancerologie Thoracique (Other)

Overall Status

Recruiting

CT.gov ID

NCT05273047

Collaborator

Amgen (Industry)

300

Enrollment

Locations

Anticipated Duration (Months)

100

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nsclc KRAS P.G12C

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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)

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

May 31, 2024

Outcome Measures

Primary Outcome Measures

Real-world progression-free survival (rwPFS) [through study completion, an average of 1.5 year]
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
Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib [6 months]
Stage cTNM, smoking habits, PS, presence of brain metastasis, gender, age, histological, KRAS and other biomarkers status
Overall survival (OS) [through study completion, an average of 1.5 year]
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
Duration of treatment with sotorasib [through study completion, an average of 1.5 year]
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
Best response (complete response, partial response, stable disease, progression) [through study completion, an average of 1.5 year]
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
Duration of response [through study completion, an average of 1.5 year]
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
Duration of treatment with sotorasib beyond 1rst progression [through study completion, an average of 1.5 year]
Duration of treatment with sotorasib beyond progression will be defined as time between first occurrence of disease progression and treatment discontinuation
Description of treatments received before and after sotorasib treatment [through study completion, an average of 1.5 year]
Description of treatments received before and after sotorasib treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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