EUCTR2019-003582-18-SE进行中（未招募）1 期
A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study ofAMG 510 Versus Docetaxel for the Treatment of Previously Treated LocallyAdvanced and Unresectable or Metastatic NSCLC Subjects With MutatedKRAS p.G12C
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen, Inc.
- 入组人数
- 330
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
- •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 have documentation of KRAS p.G12C mutation through 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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Subjects have received prior docetaxel in unresectable or metastatic setting.
- •Mixed small-cell lung cancer or mixed NSCLC histology
- •Previously identified driver mutation (according to local standard of
- •care or guidelines) 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 whole brain radiation therapy ending at least 4 weeks (or stereotactic radiosurgery ending at least 2 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.
- •Subjects 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
- •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.
- •If above antibody/antigen testing is not able to be obtained, positive
- •hepatitis B or C viral load
- •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 bisph
研究者
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