Actively Recruiting
An Interventional and Translational Study Investigating 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how sotorasib works and why resistance might develop in patients with non-small cell lung cancer (NSCLC) that has a specific KRAS p.G12C mutation. The study focuses on patients whose cancer is locally advanced or has spread, and who have previously received treatment. This phase 2 clinical trial aims to better understand sotorasib's effects and resistance mechanisms in this population. Participants will receive sotorasib tablets at a dose of 120 mg once daily by mouth. Treatment continues until the cancer progresses, unacceptable side effects occur, the participant dies, or they are lost to follow-up. The study includes pre-treatment, on-treatment, and end-of-treatment biopsy procedures to gather tissue samples. Patients must have lesions accessible for biopsy and agree to these procedures. During the study, participants will undergo tumor response assessments 4 months after starting treatment. Researchers will also monitor organ function and bone marrow reserve before registration. Patients are expected to comply with study visits and procedures, provide informed consent, and remain affiliated with a social security system. Safety and tolerability are followed closely throughout the trial period.
CONDITIONS
Brief 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 0 or 1 at screening
- Pathologically confirmed locally advanced or metastatic NSCLC with KRAS p.G12C mutation by molecular testing
- Previously treated with at least one systemic therapy for advanced or metastatic disease
- Life expectancy longer than 3 months at screening
- Lesions accessible for biopsy and willingness to undergo biopsies before, during, and after treatment
- Adequate bone marrow and organ function within 14 days before registration
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures
- Affiliation with a Social Security System or beneficiary status
You will not qualify if you...
- Unwillingness to participate in biological investigations or biopsies
- Use of certain CYP3A4 or P-gp sensitive substrates or strong CYP3A4 inducers within 14 days before registration without approval
- Inadequate washout period from prior cancer treatments (less than 14 days)
- Prior treatment with KRAS inhibitors
- Major surgery within 28 days before registration
- Significant gastrointestinal disorders affecting oral medication absorption
- Significant cardiovascular disease (e.g., NYHA class II or higher, recent myocardial infarction, unstable arrhythmias)
- Severe infections within 2 weeks prior to registration
- Ongoing or unresolved pneumonitis from prior treatments
- Peripheral neuropathy grade 2 or higher
- Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage
- Known HIV infection
- Active hepatitis B or C infection
- Leptomeningeal disease or active brain metastases unless stable and meeting specific criteria
- Pregnancy, breastfeeding, or planning pregnancy during treatment
- Inability or unwillingness to use effective contraception during and shortly after treatment
- Recent or concurrent malignancies except certain treated skin or in-situ cancers
- Participation in another interventional clinical trial
- Legal incapacity or inability to consent
- Hypersensitivity to sotorasib or excipients
- Known hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until progression, unacceptable toxicity, death, or lost to follow-up
Participants receive daily sotorasib treatment until disease progression, unacceptable toxicity, death, or loss to follow-up.
Visits occurring regularly during daily treatment as per protocol
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
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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