Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Sotorasib 120Mg Tab
DrugDaily sotorasib treatment until progression, unacceptable toxicity, death, or lost to follow-up
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Sotorasib treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tumor response assessment
To evaluate tumor response at 4 months and decipher relevant biomarkers associated with primary (progression within the first 4 months) and acquired resistance to sotorasib (progression after 4 months).
Time frame
at 4 months after treatment startSponsors and contacts
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Source ClinicalTrials.gov