Phase II study of Sotorasib plus carboplatin-pemetrexed in advanced or recurrent chemotherapy naive non-squamous, non-small cell lung cancer patients harboring KRAS G12C mutation : SCARLET study (WJOG14821L)

JRCT ID: jRCT2051210086

Registered date:22/09/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 20/10/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Induction treatment; sotorasib + carboplatin + pemetrexed for 4 courses
Maintenance treatment; sotorasib + pemetrexed, until progression
Carboplatin and pemetrexed will be administered intravenously on day 1, every 3 weeks and sotorasib will be administered orally once daily.

Outcome(s)

• Primary Outcome: Overall response by independent review
• Secondary Outcome: Overall response by investigators, Duration of response, Time to response, Disease control, Progression-free survival and Time to treatment failure (by independent review and investigators), Overall survival and Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have personally provided written consent after receiving an adequate explanation on the contents of the clinical study prior to enrollment in the study.
2) Patients who are 20 years of age or older at the day when consent is obtained.
3) Patients with histologically or cytologically confirmed non-squamous NSCLC.
4) KRAS G12C mutation is detected from tumor tissue / cytology specimen or peripheral blood.
5) Patients with stage III and stage IV NSCLC not treatable with radical radiotherapy or relapsed after radical surgery or radiotherapy.
6) Patients with measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
7) Patients should not have any history of cytotoxic chemotherapy after diagnosing as advanced disease.
9) Patients whose ECOG PS of 0 or 1
10) Patients without symptomatic brain metastases
11) Patients without meningeal carcinoma
12) Patients without Grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites.
13) Patients without severe impairment of major organs.

Exclude criteria

1) Patients with active double cancer.
2) Patients with local infection requiring surgical procedures such as drainage or systemic active infection
3) Patients who are known as positive for HIV.
4) Patients who is positive for Hepatitis B surface Antigen (HBsAg) or Hepatitis C Virus Antibody.
5) Patients with interstitial lung disease evident on computed tomography (CT).
6) Patients who require continuous systemic administration (intake or injection) of steroids higher than 10 mg/day of prednisolone equivalent due to the reasons other than endocrine or autoimmune diseases and those who require immunosuppressive agents.
7) Patients with serious cardiovascular disease such as New York Heart Association class II or higher heart disease, myocardial infarction within 6 months prior to enrollment, unstable arrhythmia or unstable angina.
8) Patients with serious gastrointestinal disorders that cause significant malabsorption, require intravenous feeding, or difficulty of oral medications.
9) Patients with genetic alterations (such as EGFR, ALK, etc.) other than KRAS G12C that are eligible for approved molecular target drugs.
10) Patients with a history of sotorasib or other KRAS G12C inhibitors.
11) Patients who are currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies) to enrollment.
12) Patients with hypersensitivity to the components and additives of carboplatin, pemetrexed, and sotorasib.
13) Pregnant women, lactating women, women who may be currently pregnant, or patients who are unwilling to use contraception.

Related Information

• Primary Sponsor: Akamatsu Hiroaki