NCT06068153撤回2 期
A Multicentre, Single-arm Phase II Trial of Sotorasib Plus Lenvatinib, As Second-line Treatment in Patients with KRASG12C-mutant, Metastatic NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 15
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
AMBER is a multicentre, single-arm phase II trial. The protocol treatment consists of of sotorasib plus lenvatinib, as a second-line treatment. The primary objective of the trial is to evaluate the clinical efficacy of sotorasib plus lenvatinib, in terms of objective response rate, for patients with KRASG12C-mutant, metastatic NSCLC.
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
- •Pathologically documented metastatic NSCLC.
- •Documented disease progression on prior treatment. Prior treatment must have included platinum-based doublet chemotherapy and immune-checkpoint inhibition.
- •KRASG12C-mutation (identified through local molecular testing, using a validated test).
- •Measurable disease per RECIST v1.1 criteria.
- •Age ≥18 years.
- •ECOG Performance Status of 0-
- •Life expectancy of >3 months.
- •Ability to swallow oral medications and willing to complete a treatment diary.
- •Adequate haematological function.
- •Adequate renal function.
- •Adequate liver function.
- •Men and women of childbearing potential must use highly effective contraception.
- •Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment.
- •Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
排除标准
- •Active brain metastases E.g., untreated brain lesions (new or progressing) and/or symptomatic brain lesions (symptoms as determined by the investigator).
- •Patients who have had brain metastases resected or have received whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 weeks) prior to enrolment are eligible if they meet all of the following criteria:
- •Residual neurological symptoms are only of grade ≤2
- •On stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable.
- •History or presence of haematological malignancies. Exception: curatively treated haematological malignancies with no disease evidence in the last 2 years.
- •History of (non-infectious) pneumonitis that required steroids or evidence of ILD/pneumonitis.
- •Active hepatitis B and C and uncontrolled HIV.
- •Uncontrolled blood pressure (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) in spite of an optimised regimen of antihypertensive medication.
- •Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, long QT syndrome (LQTS), unstable angina, myocardial infarction or stroke within 6 months before enrolment, or cardiac arrhythmia requiring medical treatment at screening
- •Bleeding or thrombotic disorders or patients at risk for severe haemorrhage. The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
- •Current or recent (within 10 days of enrolment) use of aspirin (>325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, or clostazol.
- •Electrolyte abnormalities that have not been corrected.
- •Proteinuria on urine dipstick testing >1+, unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is <2 g/24 hours.
- •History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to inclusion.
- •Unresolved toxicities from previous lines of anti-cancer treatment regimens and/or (with the exception of alopecia) complications from major surgery prior to enrolment.
- •Previous treatment with KRAS- and/or VEGF/R inhibitors.
- •Hypersensitivity to sotorasib or lenvatinib.
- •Women who are pregnant or breastfeeding or who are planning to become pregnant or breastfeed.
- •Sexually active men and women of childbearing potential who are not willing to use a highly effective contraceptive method during the trial and for 7 days after the last dose of sotorasib and until 30 days after the last dose of lenvatinib.
- •Judgment 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.
研究组 & 干预措施
Treatment Arm
Experimental
Sotorasib + Lenvatinib
干预措施: Sotorasib (Drug)
Treatment Arm
Experimental
Sotorasib + Lenvatinib
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: From date of enrolment until 18 weeks post-enrolment.
ORR is defined as the rate of patients, among all enrolled patients, achieving a best overall response \[complete response (CR) or partial response (PR)\] according to RECIST v1.1, investigator assessed, by 18 weeks post-enrolment.
次要结局
- Progression-free survival per RECIST v1.1(From the date of enrolment until last tumour assessment (approximately 22 months after the enrolment of the first patient))
- Disease control rate per RECIST v1.1(From date of enrolment until 18 weeks post-enrolment.)
- Overall survival(From the date of enrolment until death from any cause (up to 22 months after the enrolment of the first patient))
- Adverse events according to CTCAE v5.0([Time Frame: From the date of enrolment until last patient last visit (approximately 22 months after enrolment of the first patient)])
- Duration of response(From the date of enrolment until last tumour assessment or death from any cause (approximately 22 months after the enrolment of the first patient))
研究者
研究点 (15)
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