Informations générales (source: ClinicalTrials.gov)
An Interventional and Translational Study Investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C (CODEBREAK-IGR)
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
décembre 2022
juin 2027
05 décembre 2024
This study aims to provide a comprehensive understanding of sotorasib's mechanisms of
action and resistance in NSCLC patients.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Mihaela ALDEA | 18/03/2024 11:06:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Jacques CADRANEL, MD | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | NALTET Charles, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM Hôpital Nord - 13015 - Marseille - France | Pascale TOMASINI, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon - France | Aurélie SWALDUZ, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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);
- 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 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.
- 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);
- 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 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.
- 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 shorter than 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 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. 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:
1. Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic Hepatitis
B or recent acute hepatitis B)
2. 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).
3. 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:
1. residual neurological symptoms grade less or equal to 2;
2. on stable doses of dexamethasone or equivalent for at least 2 weeks, if
applicable; and
3. 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
- 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 curatively
treated;
- Participation in another clinical trial evaluating an experimental drug (except
non-interventional 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