A randomized, double-blind, parallel-group study to compare efficacy, safety, and immunogenicity of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda(R) in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Hexal AG
- 入组人数
- 720
- 试验地点
- 22
- 主要终点
- To demonstrate efficacy equivalence (BOR as per RECIST 1.1) between GME751 and Keytruda-EU in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status and with no EGFR or ALK mutations) with background platinum-based chemotherapy.
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.
Eligible participants will be randomized in a 1:1 ratio to receive either GME751, or European Union (EU)-authorized pembrolizumab (Keytruda-EU) in combination with chemotherapy. The maximum study duration for a participant will be approximately 56 weeks including screening.
Treatment duration is 52 weeks (17 treatment cycles of study treatment GME751 or Keytruda-EU in combination with chemotherapy, each cycle with a duration of 3 weeks).
Participants will discontinue study participation in case of disease progression, unacceptable toxicity or other reasons.
Participants who are benefiting from treatment with pembrolizumab without signs of progression or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •At least 18 years of age
- •Untreated metastatic NSCLC
- •Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements
- •Measurable disease according to RECIST 1.1
- •Adequate organ function
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
排除标准
- •Squamous cell or mixed histology in NSCLC
- •Known history of hypersensitivity (grade 3) to pembrolizumab, chemotherapy or their excipients
- •Active autoimmune disease that has required chronic systemic treatment in the past 2 years.
- •Received live vaccine more than 30 days before the first study treatment
- •Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer.
结局指标
主要结局
To demonstrate efficacy equivalence (BOR as per RECIST 1.1) between GME751 and Keytruda-EU in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status and with no EGFR or ALK mutations) with background platinum-based chemotherapy.
时间窗: The primary endpoint is the BOR of either CR or PR according to RECIST 1.1 up to 9 months.
次要结局
- Progression free survival - similarity between GME751 & Keytruda-EU(52 weeks)
- Overall survival - similarity between GME751 & Keytruda-EU(52 weeks)
- Duration of response in terms of Progression free survival - similarity between GME751 & Keytruda-EU(52 weeks)
- Safety in terms of TEAEs & SAEs - evaluate & compare between GME751 & Keytruda-EU(52 weeks)
- Pembrolizumab serum concentrations - To evaluate & compare between GME751 & Keytruda-EU.(Compare descriptively Ctrough of GME751 & Keytruda-EU at Week 1, 2, 4, 16 to 49 & 52 weeks)
- Immunogenicity - evaluate & compare between GME751 & Keytruda-EU(Development of binding & neutralizing ADAs up to 52 weeks.)