A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Amgen Inc.0 个研究点目标入组 650 人开始时间: 2020年3月6日最近更新: 2020年11月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 650

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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

•Subject or subject’s legally acceptable representative has provided informed consent prior to initiation of any study specific activities/procedures.
•Age = 18 years of age
•Have documentation of KRAS p.G12C mutation confirmed by central testing through the current protocol or Amgen Study 20190294 prior to enrollment.
•Subjects will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. Prior treatment must include a platinum-based doublet chemotherapy and checkpoint inhibitor for advanced or metastatic disease, either given as one line of therapy or as individual lines of therapy unless the subject has a medical contraindication to one of the required therapies. If the subject has a medical contraindication to a required therapy, the subject may be enrolled only after the investigator discusses and obtains approval from the Amgen medical monitor.
•a) Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
•b) In locally advanced and unresectable NSCLC, disease progression on or within 6 months of end of prior curatively intended multimodal therapy will count as a line of therapy. If chemoradiation is followed by planned systemic therapy without documented progression between chemoradiation and systemic therapy, the entire treatment course counts as one line of therapy.
•Subjects must have archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample [FFPE of excisional, core needle, or fine needle aspirates] collected within 5 years) or be willing to undergo pre-treatment tumor biopsy (excisional, core needle, or fine needle aspirates) prior to enrollment.
•Measurable disease per RECIST v1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation.
•ECOG Performance Status of = 1
•Adequate hematologic laboratory assessments
•Life expectancy of > 3 months, in the opinion of the investigator
•Adequate liver function
•International normalized ratio (INR) and activated partial thromboplastin time = 1.5 x ULN
•Serum creatinine = 1.5 x ULN OR creatinine clearance = 60 mL/min. Cockcroft-Gault formula will be used for creatinine clearance calculation. Twenty-four hour urine collection is not required but is allowed.
•QTc = 470 msec in females and = 450 msec in males
•Ability to take oral medications and willing to record daily adherence to investigational product
•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 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

排除标准

•Subjects have received prior docetaxel in unresectable or metastatic setting.
•Mixed small-cell lung cancer and NSCLC histology
•Previously identified driver mutation other than KRAS p.G12C for which an approved therapy is available (including EGFR, ALK, etc).
•Active brain metastases. Subjects who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade = 2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up MRI performed within 30 days prior to enrollment shows no progression or new lesions appearing.
•Leptomeningeal disease.
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Patients with PleurX catheters in place may be considered for the study with Medical Monitor approval.
•Other Medical Conditions
•Known history of Human Immunodeficiency Virus (HIV) infection
•Exclusion of hepatitis infection based on the following results and/or criteria:
•a) Positive hepatitis B surface antigen (HepBsAg)
•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).
•c) Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase chain reaction is necessary. Detectable Hepatitis C virus RNA renders the subject ineligible.
•Malignancy other than NSCLC within 3 years prior to randomization, with the exception of those with a negligible risk of metastases or death and treated with expected curative outcome.
•Major surgery within 28 days of study day 1
•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 study day 1, unstable arrhythmias or unstable angina.
•Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia.
•Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization. Prophylactic antibiotics are allowed with Amgen medical monitor approval.
•Current CTCAE version 5.0 grade = 2 peripheral neuropathy
•Prior/Concomitant Therapy
•Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (any grade allowed) or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for > 6 months), endocrine adverse events that are stably maintained on appropriate replacement therapy.
•Anti-tumor therapy within 4 weeks of study day 1; Please note that bisphosphonates or anti-Receptor Activator of Nuclear Factor Kappa Beta Ligand (anti RANKL) antibody therapy is allowed if needed for management of hypercalcemia or for prevention of skeletal events.
•Therapeutic o

研究者

发起方

Amgen Inc.

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