NCT05631249招募中2 期
An Interventional and Translational Study Investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Tumor response assessment
研究概览
简要总结
This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Life expectancy of longer than 3 months from the time of screening, in the opinion of the investigator;
- •Patients must have lesions easily accessible to biopsy and must have accepted to perform pre-treatment, on-treatment and end-of-treatment biopsies;
- •Have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to registration
- •Patients must understand, sign and date the written informed consent from prior to any protocol-specific procedures performed.
- •Patients should be able and willing to comply with study visits and procedures as per protocol.
- •Patients must be affiliated to a Social Security System or beneficiary of the same.
排除标准
- •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;
- •Prior treatment with a KRAS inhibitor.
- •Major surgery within 28 days of registration.
- •Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication.
- •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias or unstable angina.
- •Severe infections within 2 weeks prior to registration, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia. Prophylactic antibiotics are allowed.
- •Baseline or unresolved pneumonitis from prior treatment;
- •Current CTCAE version 5.0 grade higher or equal to 2 peripheral neuropathy.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Subjects with PleurX catheters in place may be considered for the study with Principal Investigator approval.
- •Known history of Human Immunodeficiency Virus (HIV) infection
- •Exclusion of hepatitis infection based on the following results and/or criteria:
- •Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute hepatitis B)
- •Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B core antibody testing is not required for screening, however if this is done and is positive, then hepatitis B surface antibody [Anti-HBs] testing is necessary.
- •Undetectable anti-HBs in this setting would suggest unclear and possible infection, and needs exclusion).
- •Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase chain reaction is necessary. Detectable Hepatitis C virus RNA renders the subject ineligible.
- •Leptomeningeal disease and active brain metastases. Subjects who have had brain metastases resected or have received whole brain radiation therapy or stereotactic radiosurgery ending at least 2 weeks prior to registration are eligible if they meet all of the following criteria:
- •residual neurological symptoms grade less or equal to 2;
- •on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and
- •follow-up brain imaging performed within 30 days of enrollment shows no progression or new lesions appearing.
- •Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 days after the last dose of sotorasib or during treatment if planning to become pregnant.
- •Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 7 days after the last dose of sotorasib
- •Female subjects of childbearing potential with a positive pregnancy test assessed at Screening or day 1 by a serum pregnancy test and/or urine pregnancy test.
- •Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib
- •Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib
- •Male subjects unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of investigational product.
- •Any evidence of primary malignancy other than locally advanced or metastatic lung cancer at within 3 years of registration, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated;
- •Participation in another clinical trial evaluating an experimental drug (except non-interventional research).
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- •Hypersensitivity to the active substance or to any excipient
- •Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
研究组 & 干预措施
Sotorasib treatment
Experimental
Sotorasib : 120 mg, once a day, per os, until progression, unacceptable toxicity, death or lost to follow-up
干预措施: Sotorasib 120Mg Tab (Drug)
结局指标
主要结局
Tumor response assessment
时间窗: at 4 months after treatment start
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).
次要结局
未报告次要终点
研究者
研究点 (5)
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