4기 비소세포폐암 환자를 대상으로 EIK1001, 펨브롤리주맙 및 화학요법의 병용 투여에 대한 안전성 및 효능 연구 (TeLuRide-008)
전 세계적, 다기관, 무작위, 이중 맹검, 위약 대조, 펨브롤리주맙 및 화학요법과 병용한 EIK1001의 4기 비소세포폐암 참가자 대상 2/3상 임상시험 (TeLuRide-008).
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Elelta Shiferraw
- 전화번호: 314-209-3659
- 이메일: shiferrawe@eikontx.com
연구 장소
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Athens, 그리스, 11516
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- Henry Dunant Hospital Center
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Gauteng
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Saxonwold, Gauteng, 남아프리카, 2196
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- The Medical Oncology Centre of Rosebank
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Western Cape
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George, Western Cape, 남아프리카, 6529
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- Task Eden
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Daegu
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Daegu, Daegu, 대한민국, 42415
- 모병
- Yeungnam University College of Medicine
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Incheon Gwang'Yeogsi
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Incheon, Incheon Gwang'Yeogsi, 대한민국, 21565
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- Gachon University - Gil Medical Center
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Jeollanam-do
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Hwasun, Jeollanam-do, 대한민국, 58128
- 모병
- Chonnam National University Hwasun Hospital (CNUHH)
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Hamburg, 독일, 22087
- 모병
- Katholische Marienkrankenhaus gGmbH
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Saxony
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Dresden, Saxony, 독일, 01307
- 모병
- University Hospital Carl Gustav Carus Dresden
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Alabama
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Daphne, Alabama, 미국, 36526
- 모병
- Southern Cancer Center, P.C.
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California
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Glendale, California, 미국, 91204
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- Los Angeles Cancer Network
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Orange, California, 미국, 92868
- 모병
- Providence St. Joseph Hospital
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Colorado
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Pueblo, Colorado, 미국, 81103
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- Rocky Mountain Cancer Centers, LLP
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Florida
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Doral, Florida, 미국, 33172
- 모병
- Omnicure Clinical Research
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Plantation, Florida, 미국, 33322
- 모병
- Florida Clinical Trials Group
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Tamarac, Florida, 미국, 33321
- 모병
- Florida Clinical Trials Group - Tamarac
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Illinois
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Peoria, Illinois, 미국, 61637
- 모병
- OSF Saint Francis Medical Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
- 모병
- University of New Mexico - Comprehensive Cancer Center
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New York
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Mineola, New York, 미국, 11501
- 모병
- NYU Langone Hospital Long Island
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New York, New York, 미국, 10016
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- NYU Langone Hospital Manhattan
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The Bronx, New York, 미국, 10461
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- Jacobi Medical Center - Albert Einstein College of Medicine
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White Plains, New York, 미국, 10601
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- White Plains Hospital
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Tennessee
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Nashville, Tennessee, 미국, 37203
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- Tennessee Oncology
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Texas
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Fort Worth, Texas, 미국, 76104
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- The Center for Cancer and Blood Disorders
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Virginia
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Blacksburg, Virginia, 미국, 24060
- 모병
- Blue Ridge Cancer Center
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Fairfax, Virginia, 미국, 22031
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- Virginia Cancer Specialists, PC
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Winchester, Virginia, 미국, 22601
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- Shenandoah Oncology P.C.
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Brussels, 벨기에, 1020
- 모병
- Centre Hospitalier Universitaire Brugmann
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, 브라질, 29308-065
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- Hospital Evangélico de Cachoeiro de Itapemirim
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Estado de Bahia
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Salvador, Estado de Bahia, 브라질, 40170-110
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- Nucleo de Oncologia da Bahia
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, 브라질, 22250-905
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- Oncoclinicas Rio de Janeiro
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Barcelona, 스페인, 08028
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- Instituto Oncologico Dr. Rosell (IOR)
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Girona, 스페인, 17007
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- Institut Catala D'Oncologia de Girona
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Málaga, 스페인, 29004
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- Hospital Quirónsalud Málaga
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Cadiz
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Jerez de la Frontera, Cadiz, 스페인, 11407
- 모병
- Hospital Universitario de Jerez de la Frontera
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Castellón
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Castellon, Castellón, 스페인, 12006
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- Consorci Hospitalari Provincial de Castello
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Malaga
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Málaga, Malaga, 스페인, 29011
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- Hospital Regional Universitario de Malaga
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Linz, 오스트리아, 4020
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- Kepler Universitaetsklinikum
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, 폴란드, 31-864
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- GCPMED Sp. z o.o., Centrum Medyczne iMed24
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New South Wales
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Frenchs Forest, New South Wales, 호주, 2086
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- Cancer Care Northern Beaches
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Waratah, New South Wales, 호주, 2298
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- Calvary Mater Newcastle Hospital
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Victoria
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Frankston, Victoria, 호주, 3199
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- Peninsula and Southeast Oncology (PASO) Medical
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Saint Albans, Victoria, 호주, 3021
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- Sunshine Hospital - Western Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
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Participant must be ≥ 18 years old at the time of signing the informed consent.
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Participant has a life expectancy of at least 3 months.
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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.
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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.
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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.
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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.
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Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
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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).
Key Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Arm 1 (Placebo in Combination with SOC)
Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC). |
Placebo control PD-1 inhibitor SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for non-squamous NSCLC |
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실험적: Arm 2 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC). |
PD-1 inhibitor SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for non-squamous NSCLC EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist |
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실험적: Arm 3 (EIK1001 in Combination with SOC)
Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC). |
PD-1 inhibitor SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for squamous NSCLC SOC Chemotherapy for non-squamous NSCLC EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free survival (PFS)
기간: Through study completion, up to 6 years
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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
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Overall survival (OS)
기간: Through study completion, up to 10 years
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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
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Objective Response (OR)
기간: Through study completion, up to 6 years
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective response (OR)
기간: Up to 6 years
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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
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Duration of response (DOR)
기간: Up to 6 years
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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
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Progression-free survival (PFS) by Investigator
기간: Up to 6 years
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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
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Overall Response Rate (ORR) by Investigator
기간: Up to 6 years
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Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator. |
Up to 6 years
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Duration of Response (DOR) by Investigator
기간: Up to 6 years
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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
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Incidence of Adverse Events (AEs)
기간: Up to 2.5 years
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Adverse Events (AEs) and discontinuation of study treatment due to any AE. |
Up to 2.5 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EIK1001-008
- 2025-525013-23-00 (씨티스)
- KEYNOTE-G57 (기타 식별자: Merck Sharp & Dohme LLC)
- MK-3475-G57 (기타 식별자: Merck Sharp & Dohme LLC)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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