A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 398
- 主要终点
- Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1
研究概览
简要总结
This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.
Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75 years old.
- •Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.
- •At least 1 measurable lesion per RECIST Version 1.1
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Adequate organ and hematologic function
排除标准
- •Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
- •Central nervous system metastasis with associated symptom and signs.
- •Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
- •History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy
- •As judged by the investigator, unsuitable for attending the study.
研究组 & 干预措施
JMT101 combined with Osimertinib
干预措施: JMT101 Injection (Drug)
JMT101 combined with Osimertinib
干预措施: Osimertinib tablet (Drug)
Cisplatin combined with pemetrexed
Participants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg/m^2 + cisplatin 75mg/m^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
干预措施: Cisplatin injection (Drug)
Cisplatin combined with pemetrexed
Participants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg/m^2 + cisplatin 75mg/m^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.
干预措施: Pemetrexed injection (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1
时间窗: Up to approximately 35 months after the first participant is randomized
次要结局
- PFS by investigator per RECIST 1.1(Up to approximately 35 months after the first participant is randomized)
- DoR by investigator per RECIST 1.1(Up to approximately 35 months after the first participant is randomized)
- Overall Survival (OS)(Up to approximately 35 months after the first participant is randomized)
- Overall Response Rate (ORR) by IRC per RECIST 1.1(Up to approximately 35 months after the first participant is randomized)
- ORR by investigator per RECIST 1.1(Up to approximately 35 months after the first participant is randomized)
- Duration of Response (DoR) by IRC per RECIST 1.1(Up to approximately 35 months after the first participant is randomized)