Actively Recruiting
Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-05-08
40
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.
CONDITIONS
Official Title
Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age higher than 18 years
- ECOG performance status of 0 or 1 at screening
- Pathologically confirmed locally advanced unresectable or metastatic NSCLC with KRAS p.G12C mutation verified by molecular testing
- Disease progression or recurrence after at least one prior systemic therapy for locally advanced or metastatic disease
- Life expectancy longer than 3 months as judged by the investigator
- Lesions accessible for biopsy and willingness to undergo pre-treatment, on-treatment, and end-of-treatment biopsies
- Adequate bone marrow and organ function based on local lab results within 14 days prior to registration
- Ability to understand, sign, and date informed consent before any protocol procedures
- Willingness and ability to comply with study visits and procedures
- Affiliation with a Social Security System or beneficiary status
You will not qualify if you...
- Unwillingness to participate in biological investigations or to undergo biopsies and blood sample collections
- Use of certain CYP3A4 or P-gp sensitive substrates or strong CYP3A4 inducers within 14 days or 5 half-lives prior to registration without investigator approval
- Inadequate washout period from previous cancer treatments less than 14 days or 5 half-lives
- Prior treatment with a KRAS inhibitor
- Major surgery within 28 days before registration
- Significant gastrointestinal disorders affecting drug absorption or requiring intravenous nutrition
- Significant cardiovascular diseases such as NYHA Class II or greater, recent myocardial infarction, unstable arrhythmias, or unstable angina
- Severe infections within 2 weeks prior to registration
- Baseline or unresolved pneumonitis from prior treatments
- Grade 2 or higher peripheral neuropathy
- Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage
- Known HIV infection
- Positive tests indicating chronic or recent hepatitis B or active hepatitis C infection
- Leptomeningeal disease or active brain metastases unless meeting specific stable criteria
- Pregnancy or breastfeeding, or unwillingness to use effective contraception during and shortly after treatment
- Male patients unwilling to abstain from sperm donation or use contraception during and shortly after treatment
- Other primary malignancies within 3 years except certain skin or treated cancers
- Participation in other experimental drug trials
- Legal incapacity to consent
- Hypersensitivity to sotorasib or its ingredients
- Hereditary intolerance to galactose, lactase deficiency, or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
2
AP-HM Hôpital Nord
Marseille, France, 13015
Actively Recruiting
3
Hôpital Paris Saint Joseph
Paris, France, 75014
Actively Recruiting
4
AP-HP Hôpital Tenon
Paris, France, 75020
Not Yet Recruiting
5
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
L
Lynda MATI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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