NL-OMON54268招募中3 期
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer - MARIPOSA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15
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
- •1. Participant must be >=18 years of age
- •2. Criterion modified per Amendment 1
- •2.1 Participant must have newly diagnosed, histologically or cytologically
- •confirmed, locally advanced or metastatic NSCLC that is treatment naïve and not
- •amenable to curative therapy including surgical resection or chemoradiation.
- •3. Criterion modified per Amendment 1.
- •3.1 The tumor (meeting criteria described in Inclusion Criterion no. 2) harbors
- •Exon 19del or Exon 21 L858R substitution, as detected by an FDA-approved or
- •other validated test in a CLIA certified laboratory (sites in the US) or an
- •accredited local laboratory (sites outside of the US) in accordance with site
- •standard of care. (Note: A copy of the test report documenting the EGFR
- •mutation must be included in the participant records and must
- •lso be submitted to the sponsor.)
- •4. Criterion modified per Amendment 1.
- •4.1 Mandatory submission of unstained tissue from tumor meeting criteria
- •described in Inclusion Criterion no. 2 (in a quantity sufficient to allow for
- •central analysis of EGFR mutation status) and blood (for ctDNA, digital droplet
- •polymerase chain reaction [ddPCR], and pharmacogenomic analysis). See Section
- •5. Any toxicities from prior anticancer therapy must have resolved to Common
- •Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline level.
- •6. at least 1 measurable lesion, according to RECIST v1.1 that has not been
- •previously irradiated.
- •Full details of inclusion criteria can be found in section 5.1 of the study
排除标准
- •1. Criterion modified per Amendment 2.
- •1.1 Participant has received any prior systemic treatment at any time for
- •locally advanced stage III or metastatic stage IV disease (adjuvant or
- •neoadjuvant therapy for stage I or II disease is allowed, if administered more
- •than 12 months prior to the development of locally advanced or metastatic
- •2. Criterion modified per Amendment 1.
- •2.1 Participant has symptomatic brain metastases. A participant with
- •asymptomatic or previously treated and stable brain metastases may participate
- •in this study.
- •3. Participant has an active or past medical history of leptomeningeal disease.
- •4. Criterion modified per Amendment 1.
- •4.1 Participant with untreated spinal cord compression. A participant that has
- •been definitively treated with surgery or radiation and has a stable
- •neurological status for at least 2 weeks prior to randomization is eligible
- •provided they are off corticosteroid treatment or receiving low-dose
- •corticosteroid treatment <=10 mg/day prednisone or equivalent.
- •6. Participant has an active or past medical history of
- •ILD/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
- •10. Participant has known allergy, hypersensitivity, or intolerance to the
- •excipients used in formulation of amivantamab, lazertinib, or osimertinib, or
- •any contraindication to the use of osimertinib
- •Full details of exclusion criteria can be found in section 5.2 of the study
研究者
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