An Interventional and Translational Study investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C - CODEBREAK-IGR

Gustave Roussy0 sites40 target enrollmentApril 11, 2022

Conditionsocally-advanced and unresectable or metastatic non-small-cell lung cancer with KRAS G12C mutation Therapeutic area: Diseases [C] - Cancer [C04]

DrugsLumykras

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ocally-advanced and unresectable or metastatic non-small-cell lung cancer with KRAS G12C mutation
Sponsor: Gustave Roussy
Enrollment: 40
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 11, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Gustave Roussy

Eligibility Criteria

Inclusion Criteria

•\- Age \= 18 years;
•\- ECOG \= 1 at the time of screening;
•\- Pathologically documented, previously treated, locally\-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted);
•\- Subjects will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
•\- Life expectancy of \> 3 months from the time of screening, in the opinion of the investigator;
•\- Patients must have lesions easily accessible to biopsy and must have accepted to perform pre\-treatment, on\-treatment and end\-of\-treatment biopsies;
•\- Have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to registration, defined as:
•Platelet count: \=100 000/mm3 or \=100 × 109/L (platelet transfusions are not allowed up to 14 days prior to registration to meet eligibility)
•Hemoglobin (Hgb): \=9\.0 g/dL (transfusion and/or growth factor support is allowed)
•Absolute neutrophil count (ANC): \=1500/mm3 or \=1\.5 × 109/L (use of growth factors is not allowed in the 14 days prior to registration)

Exclusion Criteria

•\- Patient unwilling to participate to the biological investigations and to perform biopsies and blood sample collection as required in the protocol
•\- Use of known cytochrome P450 (CYP) 3A4 or P\-gp sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half\-lives of the drug or its major active metabolite, whichever is longer, prior to registration, that was not reviewed and approved by the principal investigator
•\- Use of strong inducers of CYP3A4 (including herbal supplements such as St. John’s wort) within 14 days or 5 half\-lives (whichever is longer) prior to registration, that was not reviewed and approved by the principal investigator
•\- Inadequate washout period prior to registration, defined as: Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study \<14 days or 5 half\-lives
•\- Prior treatment with a KRAS inhibitor
•\- Major surgery within 28 days of registration
•\- Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication
•\- Significant cardiovascular disease, such as NYHA cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias or unstable angina
•\- Severe infections within 2 weeks prior to registration, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia. Prophylactic antibiotics are allowed
•\- Baseline or unresolved pneumonitis from prior treatment