EUCTR2017-001455-32-ES进行中（未招募）1 期
A proof of concept study to explore safety and efficacy of tri-therapy approach in advanced/metastatic NSCLC and retrospectively assess the ability of integrated genomics and transcriptomics to match patients to the combination - SPRING
Worldwide Innovative Network Association0 个研究点目标入组 130 人开始时间: 2018年1月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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
- •1.Age: Men and women aged >18 years,
- •2.Signed written informed consent,
- •3.Any histologic type of locally advanced or metastatic NSCLC,
- •4.Life expectancy of = 12 weeks,
- •5.Measurable or evaluable (cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST 1.1 criteria for measurable disease) lesions according to RECIST v1.1 criteria for phase 1 portion. For phase 2, all patients must have RECIST 1.1 measurable disease,
- •6.Physiologic function:
- •-Hematologic: Absolute neutrophil count (ANC) = 1.5 × 109/L, platelet count = 100 × 109/L, and hemoglobin = 9 g/dL (may have been transfused),
- •-Hepatic: Total bilirubin level = 1.5 × the upper limit of normal (ULN) range and AST and ALT levels = 2.5 × ULN,
- •-Renal: Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- •7.Pregnancy and contraception:
- •-Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential,
- •-Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after avelumab treatment administration if the risk of conception exists.
- •8.Ability to comply with protocol requirements,
- •9.Willingness to consent and ability to undergo a trucut biopsy to obtain tumor tissue from metastasis or primary tumor in case no adequate tumor tissue is available, and to undergo a bronchoscopy in order to obtain normal bronchial mucosa,
- •10.No serious or medically uncontrolled concomitant conditions that are likely to make the patient unfit for SPRING combination therapy, as per investigator assessment,
- •11.ECOG performance status of 0 to 1.
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •-Patients with documented oncogenic aberrations at enrollment: EGFR, ALK, ROS1 when available, MET exon 14 skipping when available.
- •Note: For Phase 1 portion, all patients with adenocarcinoma histology must have documentation of results for druggable oncogenic aberrations (EGFR mutations, ALK rearrangements, and ROS1 when available) prior to enrollment on the study.
- •-For Phase 1 portion, >2 lines of prior therapy in the metastatic setting.
- •-For the dose escalation phase of the study or until the MTD for the combination regimen has been determined, patients with moderate hepatic impairment defined as AST, ALT, ALP >5 times ULN, which would be grade 3 or higher. However patients with liver metastases with AST/ALT = 5 x ULN can be included in the study.
- •-For Phase 2 portion, any prior therapy in the metastatic setting.
- •Clinical exclusion criteria for Phase 1 and Phase 2 studies:
- •1.Documented untreated central nervous system metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease in the prior four weeks),
- •2.Participants with a history of myocardial infarction within the last 2 years or with significant cardiac arrhythmias uncontrolled by medication or pacemaker,
- •3.Participants with any history of interstitial lung disease,
- •4.Prior clinically significant toxicities from anticancer agents or radiotherapy which have not regressed to Grade = 1 severity (NCI-CTCAE version 4.03) apart from peripheral neuropathy and alopecia,
- •5.History of any second malignancy in the last two years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least two years,
- •6.Autoimmune condition requiring medical intervention,
- •7.Uncontrolled concomitant illness, active infection requiring i.v. antibiotics,
- •8.Participants who are at risk for, or who have a history of arterial thromboembolic events within the past 12 months and/or venous thromboembolic events within the past 6 months, or have had any recent active gastrointestinal bleeding,
- •9.Prior > G3 hemoptysis, major blood vessel involvement, and/or central cavitations,
- •10.Known or suspected drug hypersensitivity to any drug used in the combination,
- •11.Difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the oral drugs,
- •12.Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator may affect the patient’s ability to sign the informed consent and undergo study procedures,
- •13.Taking another experimental drugs within 28 days prior to day 1 of the protocol medications in this study,
- •14.Pregnant or breast-feeding women,
- •15.Both male and female patients of reproductive potential must agree to use a reliable method of birth control, during the study and for 3 months following the last dose of study drug,
- •16.Patients currently taking strong CYP3A4 inducers and inhibitors.
- •17.Patients currently taking proton pump inhibitors due to their impact on the disposition of palbociclib during the dose escalation phase,
- •18.Other anticancer agents and anticoagulants are excluded (except for low doses of anticoagulants used for access lines),
- •19.A time period of at least three weeks or five drug half-lives, whichever is
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