BridgeMD
New treatment option for KRAS P.G12C
Official title Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
ClinicalTrials.gov ID: NCT05631249
What this study is testing
What is Sotorasib 120Mg Tab?
Sotorasib 120Mg Tab is an investigational medicine, given as an once-daily, being studied as a potential treatment for kras p.g12c.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age higher than 18 years;
- ECOG less or equal to 1 at the time of screening;
- Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through...
- people will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and...
- Life expectancy of longer than 3 months from the time of screening, in the opinion of the investigator;
You likely can't join if
- 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...
- 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...
- Inadequate washout period prior to registration, defined as: Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a...
- Prior treatment with a KRAS inhibitor.
- Major surgery within 28 days of registration.
See the full eligibility criteria
Who can join
- Age higher than 18 years;
- ECOG less or equal to 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);
- people 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 longer than 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
- 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.
- Patients must be affiliated to a Social Security System or beneficiary of the same.
What rules you out
- 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...
- 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...
- 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 shorter than 14 days...
- Prior treatment with a KRAS inhibitor.
- Major surgery within 28 days of registration.
- Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication.
- Significant cardiovascular disease, such as New York Heart Association 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;
- Current CTCAE version 5.0 grade higher or equal to 2 peripheral neuropathy.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. people with PleurX catheters in place may be considered for the study with...
- Known history of Human Immunodeficiency Virus (HIV) infection
- Exclusion of hepatitis infection based on the following results and/or criteria:
- Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute hepatitis 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]...
- 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. people who have had brain metastases resected or have received whole brain radiation therapy or stereotactic radiosurgery ending at least 2 weeks prior to registration...
- residual neurological symptoms grade less or equal to 2;
- on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and
- 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 people 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 people 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 people 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...
- Male people 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 people 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...
- Participation in another clinical trial evaluating an experimental drug (except non-treatment research).
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Hypersensitivity to the active substance or to any excipient
- Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Marseille, France
- Paris, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Marseille, France; Paris, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.