A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 23
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
详细描述
This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years old at the time of signing the informed consent.
- •Participant has a life expectancy of at least 3 months.
- •Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
- •Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
- •Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
- •Participant has not received prior systemic therapy for advanced/metastatic NSCLC.
- •Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.
- •Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
- •Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is < 3yrs old).
排除标准
- •has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
- •is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
- •has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
- •has received a live-virus vaccination within 30 days of the start of study intervention initiation.
- •has received radiation therapy within 7 days of the first dose of study intervention administration.
- •has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
研究组 & 干预措施
Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
干预措施: Nab-paclitaxel + Carboplatin (Drug)
Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
干预措施: Pemetrexed + Cisplatin /Carboplatin (Drug)
Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
干预措施: Nab-paclitaxel + Carboplatin (Drug)
Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
干预措施: Pembrolizumab (KEYTRUDA®) (Drug)
Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
干预措施: Paclitaxel + Carboplatin (Drug)
Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
干预措施: Pemetrexed + Cisplatin /Carboplatin (Drug)
Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
干预措施: Pemetrexed + Cisplatin /Carboplatin (Drug)
Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
干预措施: EIK1001 (Drug)
Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
干预措施: Paclitaxel + Carboplatin (Drug)
Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
干预措施: Paclitaxel + Carboplatin (Drug)
Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
干预措施: Placebo (Drug)
Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
干预措施: Nab-paclitaxel + Carboplatin (Drug)
Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).
干预措施: EIK1001 (Drug)
Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).
干预措施: Pembrolizumab (KEYTRUDA®) (Drug)
Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).
干预措施: Pembrolizumab (KEYTRUDA®) (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Through study completion, up to 6 years
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
Overall survival (OS)
时间窗: Through study completion, up to 10 years
OS defined as the time from the first dose of study medication to death due to any cause
Objective Response (OR)
时间窗: Through study completion, up to 6 years
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
次要结局
- Objective response (OR)(Up to 6 years)
- Duration of response (DOR)(Up to 6 years)
- Progression-free survival (PFS) by Investigator(Up to 6 years)
- Overall Response Rate (ORR) by Investigator(Up to 6 years)
- Duration of Response (DOR) by Investigator(Up to 6 years)
- Incidence of Adverse Events (AEs)(Up to 2.5 years)