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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05273047
Other study ID # IFCT-2102
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Intergroupe Francophone de Cancerologie Thoracique
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 458
Est. completion date December 31, 2024
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Paris - Hôpital Cochin Paris
France Rouen - CHU Rouen
France Strasbourg - CHU Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
Intergroupe Francophone de Cancerologie Thoracique Amgen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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