Clinical trial · Observational
RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC
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)
NCT05273047CI-TRIAL-00070058LungKG12CiunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS P.G12C | — | UNRESOLVED | — |
| Nsclc | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (8)
- measure
- Real-world progression-free survival (rwPFS)
- timeFrame
- through study completion, an average of 1.5 year
- description
- 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
- measure
- Patients' clinical and biological characteristics at NSCLC diagnosis and initiation of sotorasib
- timeFrame
- 6 months
- description
- Stage cTNM, smoking habits, PS, presence of brain metastasis, gender, age, histological, KRAS and other biomarkers status
- measure
- Overall survival (OS)
- timeFrame
- through study completion, an average of 1.5 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.