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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nsclc; KRAS P.G12C

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.

• Study Type: Observational
• Enrollment (Actual): 458

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Paris - Hôpital Cochin
  • Rouen, France
    • Rouen - CHU
  • Strasbourg, France
    • Strasbourg - CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring KRAS G12C mutation who received sotorasib as second line treatment or more as part of the French Early Access Program (ATU program).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Collaborators: Amgen
• Investigators: Study Chair: Céline Mascaux, Strasbourg - CHU; Study Chair: Florian Guisier, Rouen - CHU

Publications and helpful links

Helpful Links

• IFCT website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: NSCLC; IFCT; real-world study; sotorasib; KRAS P.G12C
• Other Study ID Numbers: IFCT-2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No