EUCTR2022-002736-31-IE进行中（未招募）1 期
A multicentre, single-arm phase II trial of adagrasib in patients with KRASG12C-mutant NSCLC, including the elderly (=70 years) or patients with poor performance status - ADEPPT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically or cytologically confirmed stage IV NSCLC
- •- KRASG12C-mutation by local testing (by tissue or ctDNA)
- •- 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).
- •- Life expectancy =12 weeks
- •- Measurable disease according to RECIST v1.1
- •- Age =18 years with ECOG PS 2 (cohort 1), or age =70 years with ECOG PS 0-1 (cohort 2)
- •- Adequate haematological, renal and liver function
- •- Negative pregnancy test for patients of childbearing potential
- •- Ability to comply with the trial protocol, in the investigator's judgment.
- •-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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •-Prior investigational therapy within 28 days or at least 5 half-lives before enrolment
- •-Prior treatment with an agent targeting KRASG12C
- •-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
- •- History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications.
- •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
- •-History of stroke or transient ischemic attack within 6 months prior to enrolment
- •-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
- •-Known human immunodeficiency virus (HIV) infection
- •-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])
- •-Women who are pregnant or in the period of lactation
- •-Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
- •-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
研究者
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