An Interventional and Translational Study investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C (CODEBREAK)
- Conditions
- locally-advanced and unresectable or metastatic NSCLC with KRAS G12CMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864MedDRA version: 25.1Level: LLTClassification code: 10069759Term: KRAS mutation Class: 10018065Therapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2024-510837-16-00
- Lead Sponsor
- Institut Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Age = 18 years;, Patients must be affiliated to a Social Security System or beneficiary of the same., 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 in the table (please refer to the protocol), Patients must understand, sign and date the written informed consent from prior to any protocol-specific procedures performed., Patients should be able and willing to comply with study visits and procedures as per protocol.
Patient unwilling to participate to the biological investigations and to perform biopsies and blood sample collection as required in the protocol;, Baseline or unresolved pneumonitis from prior treatment;, Current CTCAE version 5.0 grade = 2 peripheral neuropathy., Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Subjects with PleurX catheters in place may be considered for the study with Principal Investigator approval., Known history of Human Immunodeficiency Virus (HIV) infection, Exclusion of hepatitis infection based on the following results and/or criteria: a) Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute hepatitis B) b) Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B core antibody testing is not required for screening, however if this is done and is positive, then hepatitis B surface antibody [Anti-HBs] testing is necessary. Undetectable anti-HBs in this setting would suggest unclear and possible infection, and needs exclusion). c) Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase chain reaction is necessary. Detectable Hepatitis C virus RNA renders the subject ineligible., Leptomeningeal disease and active brain metastases. Subjects who have had brain metastases resected or have received whole brain radiation therapy or stereotactic radiosurgery ending at least 2 weeks prior to registration are eligible if they meet all of the following criteria: o a) residual neurological symptoms grade = 2; o b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and o c) follow-up brain imaging performed within 30 days of enrollment shows no progression or new lesions appearing., Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 days after the last dose of sotorasib or during treatment if planning to become pregnant., Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 7 days after the last dose of sotorasib, Female subjects of childbearing potential with a positive pregnancy test assessed at Screening or day 1 by a serum pregnancy test and/or urine pregnancy test., Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib, 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., Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib, Male subjects unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of investigational product., Any evidence of primary malignancy other than locally advanced or metastatic lung cancer at within 3 years of registration, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curative
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method