KRAS P.G12C, Nsclc
Conditions
Keywords
sotorasib, real-world study, KRAS P.G12C, NSCLC, IFCT
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.
Detailed 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.
Interventions
None listed
Sponsors
Amgen
Intergroupe Francophone de Cancerologie Thoracique
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed