CTRI/2022/01/039158进行中（未招募）3 期
A Phase 3 Open-Label Randomized Study of Amivantamab and Lazertinib inCombination with Platinum Based Chemotherapy Compared with Platinum Based Chemotherapy in Patients with EGFR Mutated Locally Advanced orMetastatic Non Small Cell Lung Cancer After Osimertinib Failure
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to assess the efficacy of lazertinib, amivantamab, carboplatin, and pemetrexed (LACP) compared with carboplatin and pemetrexed (CP), in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant must have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST version 1 point 1 that has not been previously irradiated Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer NSCLC, characterized at or after the tine of locally advanced metastatic disease diagnosis by either epidermal growth factor receptor EGFR Exon 19del or Exon 21 L858R mutation A participant with definitively locally treated brain metastases must be clinically stable and asymptomatic, with or without low-dose corticosteroid treatment less than or equal to 10 milligrams mg prednisone or equivalent, for at least 14 days prior to randomization Participant must have Eastern Cooperative Oncology Group ECOG status of 0 or 1 Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE Version 5 point 0 Grade 1 or baseline level except for alopecia any grade, Grade less than or equal to 2 peripheral neuropathy, or Grade less than or equal to two hypothyroidism stable on hormone replacement A woman of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second line setting after prior treatment with first or second generation EGFR tyrosine kinase inhibitor TKI.
- •Participants who received either neoadjuvant and/or adjuvant treatment are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting.
- •Treatment with osimertinib must be discontinued at least 8 days 4 half lives prior to randomization that is last dose no later than Day 8.
排除标准
- •Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization Participant has active brain metastases not definitively treated with local therapy Participant has leptomeningeal disease or participant has spinal cord compression not definitively treated with surgery or radiation Participant has known small cell transformation Participant has a medical history of interstitial lung disease ILD including drug induced ILD or radiation pneumonitis.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Upto 17 months
According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central
时间窗: Upto 17 months
Review (BICR)
时间窗: Upto 17 months
次要结局
- Overall Survival (OS)(Up to 48 months)
- Duration of Response (DoR)(Up to 17 months)
- Number of Participants with Adverse Events AEs
- Time to Symptomatic Progression(Upto 17 months)
- Time to Subsequent Therapy (TTST)(Up to 17 months)
- Objective Response as Assessed by BICR(Up to 17 months)
- Progression-Free Survival After First Subsequent Therapy (PFS2)
- Intracranial PFS(Up to 17 months)
- Number of Participants with Clinical Laboratory Abnormalities
- Serum Concentration of Amivantamab(Up to 17 months)
- European Organization of Research and Treatment of Cancer Quality of Life(Questionnaire Core 30)
- Patient Reported Outcomes(Measurement Information System Physical Function)
- Plasma Concentration of Lazertinib(Up to 17 months)
- Number of Participants with AntiAmivantamab Antibodies(Upto 17 months)
- Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire(Up to 17 months)
研究者
研究点 (9)
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