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 G12C

Brief summary

The clinical evaluation endpoints will be evaluated using RECIST v1.1 with the following parameters: ➢ OR is defined as the achievement of a confirmed complete response (CR) or partial response (PR) observed on treatment and assessed by investigators. Confirmation of response must be demonstrated with an assessment four weeks or later from the initial response. Treatment objective response will be radiologically assessed every eight weeks using RECIST v1.1., ➢ PFS is defined as the time from date of the first dose of sotorasib until to the earlier of the dates of the first objective documentation of progression or death from any cause, whichever occurs first. At the time of analysis, the patient alive and without progression will be censored at the date of the last tumor assessment., ➢ OS is defined as the time from date of the first sotorasib dose until death. Patients alive at last follow-up will be censored.

Detailed description

Co-mutations, mutational signatures and TMB at baseline;, Acquired mutations under treatment and at treatment progression;, Mutation status and proteic changes on viable patient-derived xenografts models;, Immune phenotype status at baseline, under treatment and at time of progression;, Transcriptomic signatures at baseline, under treatment and at time of progression.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGLUMYKRAS 120 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The clinical evaluation endpoints will be evaluated using RECIST v1.1 with the following parameters: ➢ OR is defined as the achievement of a confirmed complete response (CR) or partial response (PR) observed on treatment and assessed by investigators. Confirmation of response must be demonstrated with an assessment four weeks or later from the initial response. Treatment objective response will be radiologically assessed every eight weeks using RECIST v1.1., ➢ PFS is defined as the time from date of the first dose of sotorasib until to the earlier of the dates of the first objective documentation of progression or death from any cause, whichever occurs first. At the time of analysis, the patient alive and without progression will be censored at the date of the last tumor assessment., ➢ OS is defined as the time from date of the first sotorasib dose until death. Patients alive at last follow-up will be censored.	—

Measure

Time frame

The clinical evaluation endpoints will be evaluated using RECIST v1.1 with the following parameters: ➢ OR is defined as the achievement of a confirmed complete response (CR) or partial response (PR) observed on treatment and assessed by investigators. Confirmation of response must be demonstrated with an assessment four weeks or later from the initial response. Treatment objective response will be radiologically assessed every eight weeks using RECIST v1.1., ➢ PFS is defined as the time from date of the first dose of sotorasib until to the earlier of the dates of the first objective documentation of progression or death from any cause, whichever occurs first. At the time of analysis, the patient alive and without progression will be censored at the date of the last tumor assessment., ➢ OS is defined as the time from date of the first sotorasib dose until death. Patients alive at last follow-up will be censored.

—

Secondary

Measure	Time frame
Co-mutations, mutational signatures and TMB at baseline;, Acquired mutations under treatment and at treatment progression;, Mutation status and proteic changes on viable patient-derived xenografts models;, Immune phenotype status at baseline, under treatment and at time of progression;, Transcriptomic signatures at baseline, under treatment and at time of progression.	—

Countries

France

Outcome results

None listed