RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC

NCT05273047 | Unknown

• 1 other identifier: IFCT-2102
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 3

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.

Conditions

Nsclc; KRAS P.G12C

Keywords

sotorasib; real-world study; KRAS P.G12C; NSCLC; IFCT

Outcome Measures

Primary Outcomes (8)

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead
• Amgen: collaborator

Study Sites (3)

Paris - Hôpital Cochin

Paris, France

Location

Rouen - CHU

Rouen, France

Location

Strasbourg - CHU

Strasbourg, France

Location

Related Links

• IFCT website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Céline Mascaux

  Strasbourg - CHU

  STUDY CHAIR

• Florian Guisier

  Rouen - CHU

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)