NL-OMON56228已完成3 期
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 - 20190009_NSCLC Subjects With KRAS p.G12C
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 56
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
- •Histologically or pathologically documented, locally-advanced and unresectable
- •or metastatic NSCLC.
- •104. 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.
- •105. Subjects will have received and progressed or experienced disease
- •recurrence on or after 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.
- •c) Maintenance therapy following platinum doublet-based chemotherapy is not
- •considered as a separate line of therapy.
- •106. Subjects must have archived tumor tissue samples collected within 5 years
- •or be willing to undergo pre-treatment tumor biopsy for tissue prior to
- •enrollment.
- •107. Measurable disease per RECIST v1.1 criteria. Lesions previously radiated
- •are not considered measurable unless they have progressed after radiation.
- •108. ECOG Performance Status of =< 1
- •109. Adequate hematologic laboratory assessments, defined as the following
- •within 10 days prior to start of study therapy:
- •110. Life expectancy of > 3 months, in the opinion of the investigator
- •Please refer to section 5.1 of the protocol.
排除标准
- •Subjects have received prior docetaxel in unresectable or metastatic setting
- •(including subjects who received prior docetaxel in first line for metastatic
- •disease, but not including subjects who received prior docetaxel neoadjuvantly
- •or adjuvantly and did not progress within 6 months of end of therapy).
- •202. Mixed small-cell lung cancer or mixed NSCLC histology
- •203. 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).
- •204. 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.
- •Active brain metastases are defined as: Untreated brain lesions (new or
- •progressing) and/or symptomatic brain lesions (symptoms as determined by the
- •investigator), present at the time of study entry.
- •205. Leptomeningeal disease.
- •206. 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, Prior/Concomitant Therapy, Prior/Concurrent Clinical
- •Study Experience and Other Exclusions are listed in protocol page 52-55
- •Please refer to section 5.2 of the protocol.
研究者
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