Clinical trial NCT05273047: RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nsclc
KRAS P.G12C
Keywords: sotorasib
real-world study
KRAS P.G12C
NSCLC
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2022-03-10
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Real-world progression-free survival (rwPFS)
timeFrame: through study completion, an average of 1.5 year
measure: Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib
timeFrame: 6 months
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1.5 year
measure: Duration of treatment with sotorasib
timeFrame: through study completion, an average of 1.5 year
measure: Best response (complete response, partial response, stable disease, progression)
timeFrame: through study completion, an average of 1.5 year
measure: Duration of response
timeFrame: through study completion, an average of 1.5 year
measure: Duration of treatment with sotorasib beyond 1rst progression
timeFrame: through study completion, an average of 1.5 year
measure: Description of treatments received before and after sotorasib treatment
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris - Hôpital Cochin
city: Rouen
country: France
facility: Rouen - CHU
city: Strasbourg
country: France
facility: Strasbourg - CHU
Study officials:
affiliation: Strasbourg - CHU
name: Céline Mascaux
role: STUDY_CHAIR
affiliation: Rouen - CHU
name: Florian Guisier
role: STUDY_CHAIR
References: