A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 plus Chemotherapy versus Keytruda® plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants with Stage IV Non-squamous Non-small Cell Lung Cancer.
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 676
- 试验地点
- 16
- 主要终点
- 1. To compare the pairwise PK similarities between BAT3306 and EU-Keytruda®, BAT3306 and US-Keytruda®, and between EU-Keytruda® and US-Keytruda® in participants with nsNSCLC
概览
简要总结
This is a multi-center, double-blind, randomized Phase I/III study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.
Randomization will occur after the presence of at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 is confirmed. All participants will receive investigational medicinal product (IMP) (BAT3306, EU-Keytruda®, or US-Keytruda®), pemetrexed and carboplatin every 3 weeks up to 4 cycles, followed for those with non-progressive disease with maintenance therapy comprising IMP plus pemetrexed until a maximum of 12 months.
Participants still benefitting by the therapy at 12 months will have the option to receive treatment in the long-term extension period.
All participants will receive study treatment until there is an Investigator-assessed disease
progression, lack of clinical benefit, unacceptable adverse events, participant withdrawn from the study based on Investigator’s judgment, withdrawal of consent, lost to follow-up, death, start of a new anti-cancer therapy, study termination by the Sponsor, or for a maximum month of treatment (end of study), whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria are met:
- •Male or female, age ≥18 years on the day of signing informed consent.
- •Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
- •Life expectancy ≥3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC.
- •Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.
排除标准
- •Participant must be excluded from participating in the study if the participant: Medical Conditions
- •Is pregnant or a nursing female.
- •Has predominantly squamous cell histology NSCLC.
- •Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
- •Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.
结局指标
主要结局
1. To compare the pairwise PK similarities between BAT3306 and EU-Keytruda®, BAT3306 and US-Keytruda®, and between EU-Keytruda® and US-Keytruda® in participants with nsNSCLC
时间窗: 1. PK parameters at Cycle 6, 1st cycle at Cycle 1 | 2. Confirmed best overall tumor response rate up to Week 24
2. To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLC
时间窗: 1. PK parameters at Cycle 6, 1st cycle at Cycle 1 | 2. Confirmed best overall tumor response rate up to Week 24
次要结局
- 1. To evaluate the PK characteristics of BAT3306, EU-Keytruda®, & US-Keytruda® in participants with nsNSCLC(1. PK parameters at Cycle 1 & Cycle 6)
- 2. To evaluate the immunogenicity of BAT3306 & pooled EU-Keytruda® & US-Keytruda® in participants with nsNSCLC(2. Immunogenicity evaluation at Week 2, Week 4, Week 12, Week 18, Week 24, Week 36, Week 54 & EOT)
- 3. To further evaluate the efficacy of BAT3306 & pooled EU-Keytruda® & US Keytruda® given with chemotherapy(At Week 6, Week 12, Week 18, & Week 24)