EUCTR2017-003134-85-ES进行中（未招募）1 期
A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT) - KeyImPaCT: Keytruda Immunotherapy Personalized and Combination Treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
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
入选标准
- •1.Have a histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v. 8) NSCLC and study participants should not have had prior systemic therapy for advanced disease.
- •2. Have confirmation that epidermal growth factor receptor– (EGFR-),anaplastic lymphoma kinase– (ALK-), c-ros oncogene 1 (ROS1), or Bisoform of rapidly accelerated fibrosarcoma (B-Raf) directed therapy is not indicated as primary therapy (documentation of absence of tumor activating EGFR or B-Raf mutations AND absence of ALK or ROS1 gene rearrangements). If participant's tumor is known to have a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations will not be required, as this is not part of current diagnostic guidelines.
- •3. Have measurable disease per RECIST 1.1 as assessed by the local site
- •investigator/radiology. Lesions situated in a previously irradiated area
- •are considered measurable if progression has been demonstrated in such lesions.
- •4. Male/female subjects who are at least 18 years of age on the day of
- •signing the informed consent.
- •5. A male participant must agree to use a contraceptive as detailed in the protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- •6. A female participant is eligible to participate if she is not pregnant,
- •not breastfeeding, and at least one of the following conditions applies:
- •a.) Not a woman of childbearing potential (WOCBP)
- •b.) A WOCBP who agrees to follow the contraceptive guidance in the
- •protocol during the treatment period and for at least 120 days after the
- •last dose of study treatment.
- •7. The participant (or legally acceptable representative if applicable)
- •provides written informed consent for the study. The participant may
- •also provide consent for Future Biomedical Research. However, the
- •participant may participate in the main study without participating in
- •Future Biomedical Research.
- •8. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Newly
- •obtained biopsies are preferred to archival tissue. Repeat samples may
- •be required if adequate tissue is not provided.
- •9. Participants must have adequately controlled blood pressure (BP)
- •with or without antihypertensive medications, defined as BP =150/90
- •mm Hg at Screening and no change in antihypertensive medications
- •within 1 week before Cycle 1/Day 1.
- •10. Have an Eastern Cooperative Oncology Group (ECOG) performance
- •status of 0 to 1.
- •11. Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of study treatment.
- •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 96
- •F.1.3 Elderly (>=65 years) yes
排除标准
- •1. Has significant cardiovascular impairment within 12 months of the
- •first dose of study drug: such as history of congestive heart failure
- •greater than NYHA Class II, unstable angina, myocardial infarction or
- •cerebrovascular accident (CVA) stroke, cardiac arrhythmia associated
- •with hemodynamic instability, or a left ventricular ejection fraction
- •(LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram.
- •2. Prolongation of QTc interval to >480 ms.
- •3. Has symptomatic ascites or pleural effusion. A participant who is
- •clinically stable following treatment for these conditions is eligible.
- •4. Has had an allogenic tissue/solid organ transplant.
- •5. A WOCBP who has a positive urine pregnancy test within 72 hours
- •before the first dose of study treatment.
- •6. Subjects with proteinuria >1+ on urine dipstick testing will undergo
- •24-hour urine collection for quantitative assessment of proteinuria.
- •Subjects with urine protein =1 g/24 h will be ineligible.
- •7. Subjects who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
- •8. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any
- •other condition that might affect the absorption of lenvatinib
- •9. Radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage
- •associated with tumor shrinkage/necrosis following lenvatinib therapy.
- •10. Clinically significant hemoptysis or tumor bleeding within 2 weeks
- •prior to the first dose of study drug.
- •11. Has received prior systemic chemotherapy treatment for
- •metastatic/recurrent NSCLC.
- •12. Has current NSCLC disease that can be treated with curative intent
- •with surgical resection, localized radiotherapy, or chemoradiation.
- •13. Is expected to require any other form of systemic or localized
- •antineoplastic therapy while on study.
- •14. Has received prior therapy with an anti–PD-1, anti–PD-L1, or anti–
- •PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T cell receptor (eg, CTLA-4, OX 40, CD137).
- •15. Has received previous treatment with another agent targeting the
- •LAG3 receptor.
- •16. Has received previous treatment with another agent targeting VEGF
- •or the VEGF receptor.
- •17. Has received prior anticancer therapy including investigational
- •agents within 4 weeks prior to randomization.
- •18. Has received prior radiotherapy within 3 weeks of start of study
- •19. Has received a live vaccine within 30 days prior to the first dose of
- •study treatment.
- •20. Is currently participating in or has participated in a study of an
- •investigational agent or has used an investigational device within 4
- •weeks prior to the fi
研究者
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