NL-OMON52430已完成2 期
A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study) - MS200095-0031
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Merck
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants are eligible to be included in the study only if all the following
- •criteria apply:
- •1. Are >= 18 years of age (or having reached the age of majority according to
- •local laws and regulations, if the age of majority is > 18 years of age [ie, >=
- •20 years of age in Japan]), at the time of signing the informed consent.
- •2. Are participants with the following:
- •a) Locally advanced or metastatic NSCLC histology (confirmed by either
- •histology or cytology) with documented activating EGFR mutation
- •b) Presence of at least 1 independently verified measurable lesion in
- •accordance with RECIST 1.1, that can be accurately assessed at baseline with >=
- •10 mm in the longest diameter (except lymph nodes which must have short axis >=
- •15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), which
- •is suitable for accurate repeated measurements and that preferably was not
- •previously irradiated or biopsied
- •c) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a
- •minimum life expectancy of 12 weeks
- •d) Acquired resistance on previous first-line-osimertinib. Participants must
- •meet both of the following 2 criteria:
- •-Radiological documentation of disease progression first-lineosimertinib.
- •-Objective clinical benefit documented during previous osimertinib therapy,
- •defined by either partial or complete radiological response, or durable stable
- •disease (SD) (SD should last > 6 months) after initiation
- •of osimertinib
- •e) Have received only first line osimertinib as a prior line of therapy in the
- •noncurative advanced or metastatic NSCLC setting
- •f) MET amplification as determined by either FISH testing (central or local) on
- •tumor tissue (TBx) or central blood-based next generation sequencing (LBx).
- •Tumor and blood samples must be collected following progression on prior
- •first-line osimertinib at Prescreening.
- •-Submission of tumor tissue and blood sample obtained after progression on
- •first line osimertinib, is mandatory for all patients for MET amplification
- •-Submission of tumor tissue during Prescreening or Screening is mandatory for
- •patients with tumor tissue tested by local FISH, to confirm MET amplification
- •status. Central testing is not mandated prior to the start of study treatment
- •3. Woman: no woman of childbearing potential (WOCBP) or, use a highly effective
- •contraception. Man: contraception or no intercourse with a WOBCP.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Spinal cord compression or brain metastasis unless asymptomatic, stable or
- •not requiring steroids for at least 2 weeks prior to start of study
- •intervention. Prior radiotherapy or surgery for brain metastases such as
- •stereotactic radiosurgery/gamma knife must have been completed >= 2 weeks, all
- •others >= 4 weeks prior to start of therapy. Participants with leptomeningeal
- •disease are ineligible.
- •2. Any unresolved toxicity Grade 2 or more according to National Cancer
- •Institute-Common Terminology Criteria for Adverse Events Version (NCI-CTCAE)
- •version 5, from previous anticancer therapy with the exception of alopecia.
- •3. Need for transfusion within 14 days prior to the first dose of study
- •intervention.
- •4. Participants who have brain metastasis as the only measurable lesion
- •5. Inadequate hematological function:
- •- Hemoglobin < 8.5 g/dL
- •- Neutrophils < 1.5 × 109/L
- •- Platelets < 100 × 109/L.
- •6. Inadequate liver function:
- •- Total bilirubin > 1.5 × ULN
- •- AST/ALT/ALP > 3 × ULN
- •- For participants with liver metastases:
- •i. Total bilirubin > 1.5 × ULN
- •ii. AST/ALT/ALP > 5 × ULN
- •iii. For participants with bone metastases: ALP > 5 × ULN.
- •7. Inadequate renal function:
- •- Renal impairment as evidenced by serum creatinine >= 1.5 × ULN, or creatinine
- •clearance (CrCl) < 30 mL/min calculated by the Cockcroft- Gault formula
- •(24-hour CrCl might be requested by the Investigator for confirmation, if
- •calculated CrCl is < 50 mL/min. In such case, participants with 24-hour CrCl <
- •30 mL/min should be excluded). CrCl (mL/min) = [(140 - age(year)) × weight(kg)]
- •72 × serum creatinine (mg/dL) {× 0.85 for females}
- •8. History of ILD or interstitial pneumonitis including radiation pneumonitis
- •that required steroid treatment.
- •9. Impaired cardiac function:
- •-Left ventricular ejection fraction < 45% defined by echocardiography
- •- Grade 4 arrhythmia (NCI-CTCAE v5.0)
- •-Serious arrhythmia
- •-Unstable angina pectoris
- •-Congestive Heart Failure New York Heart Association III and IV
- •- Myocardial infarction, stroke, or transient ischemic attack within the last 6
- •months prior to study entry.
- •10. Corrected QT interval by Fredericia (QTcF) > 470 ms for women and
- •> 450 ms for men at screening.Any factors that increase the risk of QTc
- •prolongation or risk of arrhythmic events such as hypokalemia, congenital long
- •QT syndrome, family history of long QT syndrome or unexplained sudden death
- •under 40 years of age in first degree relatives, or any concomitant medication
- •known to prolong the QT interval and cause Torsade de Pointes.
- •11. Hypertension uncontrolled by standard therapies (not stabilized to < 150/90
- •12. Contraindication to the administration of osimertinib.
- •13. Medical history of liver fibrosis/cirrhosis.
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