임상 레이더 AI | ||
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임상시험 NCT07365319 (TeLuRide-008)은(는) Non Small Cell Lung Cancer (Squamous or Non Squamous), Stage 4 NSCLC에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer. (TeLuRide-008) 2상, 3상 750
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).
- TeLuRide-008
- EIK1001-008
- 2025-525013-23-00 (EU 시험 (CTIS) 번호)
- KEYNOTE-G57 (기타 식별자) (Merck Sharp & Dohme LLC)
- MK-3475-G57 (기타 식별자) (Merck Sharp & Dohme LLC)
3상
EIK1001
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
위약 대조군Arm 1 (Placebo in Combination with SOC) Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC). | Pembrolizumab (KEYTRUDA®) PD-1 inhibitor 위약 Placebo control Paclitaxel + Carboplatin SOC Chemotherapy for squamous NSCLC Nab-paclitaxel + Carboplatin SOC Chemotherapy for squamous NSCLC Pemetrexed + Cisplatin /Carboplatin SOC Chemotherapy for non-squamous NSCLC |
실험적Arm 2 (EIK1001 in Combination with SOC) Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC). | EIK1001 EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist Pembrolizumab (KEYTRUDA®) PD-1 inhibitor Paclitaxel + Carboplatin SOC Chemotherapy for squamous NSCLC Nab-paclitaxel + Carboplatin SOC Chemotherapy for squamous NSCLC Pemetrexed + Cisplatin /Carboplatin SOC Chemotherapy for non-squamous NSCLC |
실험적Arm 3 (EIK1001 in Combination with SOC) Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC). | EIK1001 EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist Pembrolizumab (KEYTRUDA®) PD-1 inhibitor Paclitaxel + Carboplatin SOC Chemotherapy for squamous NSCLC Nab-paclitaxel + Carboplatin SOC Chemotherapy for squamous NSCLC Pemetrexed + Cisplatin /Carboplatin SOC Chemotherapy for non-squamous NSCLC |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Progression-free survival (PFS) | 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 | Through study completion, up to 6 years |
Overall survival (OS) | OS defined as the time from the first dose of study medication to death due to any cause | Through study completion, up to 10 years |
Objective Response (OR) | 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). | Through study completion, up to 6 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Objective response (OR) | Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR | Up to 6 years |
Duration of response (DOR) | DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR. | Up to 6 years |
Progression-free survival (PFS) by Investigator | 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 Investigator, or death due to any cause, whichever occurs first. | Up to 6 years |
Overall Response Rate (ORR) by Investigator | Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator. | Up to 6 years |
Duration of Response (DOR) by Investigator | DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by Investigator. | Up to 6 years |
Incidence of Adverse Events (AEs) | Adverse Events (AEs) and discontinuation of study treatment due to any AE. | Up to 2.5 years |
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).
- 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.
Eikon Therapeutics머크