ADAGRASIB for Non-small cell lung cancer|KRAS G12C mutation

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed stage IV NSCLC\n- KRASG12C-mutation by local testing (by tissue or ctDNA)\n- Prior treatment with at least one line of systemic therapy for NSCLC (e.g., platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).\n- Life expectancy ≥12 weeks\n- Measurable disease according to RECIST v1.1\n- Age ≥18 years with ECOG PS 2 (cohort 1), or age ≥70 years with ECOG PS 0-1 (cohort 2)\n- Adequate haematological, renal and liver function\n- Negative pregnancy test for patients of childbearing potential\n- Ability to comply with the trial protocol, in the investigator's judgment.\n- Written informed consent for protocol treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention, including the submission of mandatory biomaterial."}

Exclusion criteria

• {"criterion_text":"- Prior investigational therapy within 28 days or at least 5 half-lives before enrolment\n- Prior treatment with an agent targeting KRASG12C\n- Leptomeningeal disease or untreated brain metastases: – Patient should be neurologically stable for at least 2 weeks before enrolment, without the need for corticosteroids, except for prednisone (or its equivalent) at a dose of ≤10 mg daily – For patients with definitively treated brain metastases, a minimum of 2 weeks must have elapsed from the last day of radiotherapy\n- History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.\n- Any of the following cardiac abnormalities: – Unstable angina pectoris or myocardial infarction within 6 months prior to enrolment. – Symptomatic or uncontrolled atrial fibrillation within 6 months prior to enrolment. – Congestive heart failure ≥NYHA Class 3 within 6 months prior to enrolment. – Prolonged QTc interval >480 ms or family or medical history of congenital Long QT Syndrome\n- History of stroke or transient ischemic attack within 6 months prior to enrolment\n- Ongoing need for treatment with concomitant medication with any of the following characteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrow therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP; and proton pump inhibitors that cannot be switched to alternative treatment prior to enrolment\n- Known human immunodeficiency virus (HIV) infection\n- Acute or chronic hepatitis B or C infection. Note that the following are permitted: a. Patients treated for hepatitis C (HCV) with no detectable viral load at screening; b. Patients treated for HIV with no detectable viral load for at least 1 month prior to enrolment; and c. Patients with hepatitis B (HBV) receiving prophylaxis against reactivation of hepatitis B (either [HBsAg-positive with normal ALT and HBV DNA <2,000 IU/mL or <10,000 copies/mL] or [HBsAg-negative and anti-HBcAg-positive])\n- Women who are pregnant or in the period of lactation\n- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study\n- Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements"}

Primary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR) per RECIST v1.1, assessed at 12 weeks.","definition_or_measurement_approach":"ORR per RECIST v1.1, assessment at 12 weeks"}

Secondary endpoints

• {"endpoint_text":"- Durable clinical benefit (DCB)\n- Time to progression (TTP)\n- Progression-free Survival (PFS)\n- Overall Survival (OS)\n- Safety\n- Patient-related outcomes","definition_or_measurement_approach":"Evaluation of measures of clinical efficacy including durable clinical benefit (DCB), time-to-progression (TTP), progression-free survival (PFS), overall survival (OS), overall safety and patient-related outcomes (no further measurement definitions provided in source)"}

Belgium

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

245

Number Of Sites

1

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

30-10-2024

Processing Time Days

245

Number Of Sites

8

Number Of Participants

15

France

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

637

Number Of Sites

4

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

637

Number Of Sites

4

Number Of Participants

15

Ireland

Earliest CTIS Part Ii Submission Date

28-02-2024

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

783

Number Of Sites

3

Number Of Participants

8

Primary sponsor

Full Name

ETOP IBCSG Partners Foundation

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Switzerland

Third parties

• {"country":"Greece","full_name":"Frontier Science Foundation-Hellas","duties_or_roles":"Sponsor duties (code 10) (no further detail provided)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"Centre Hospitalier Universitaire Vaudois","duties_or_roles":"biobanking, RNA profiling, analysis of ctDNA and cytokines","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Drug storage and distribution to participating trial sites","organisation_type":"Pharmaceutical company"}