RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC

Nsclc Clinical Trial

— LungKG12Ci  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05273047
• Other study ID #: IFCT-2102
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Nsclc

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

External Links

•   IFCT website