Een onderzoek naar de veiligheid en werkzaamheid van EIK1001 in combinatie met pembrolizumab en chemotherapie bij deelnemers met stadium 4 niet-kleincellig longkanker. (TeLuRide-008)
Een wereldwijde, multicenter, gerandomiseerde, dubbelblinde, placebo-gecontroleerde, fase 2/3-studie van EIK1001 in combinatie met pembrolizumab en chemotherapie bij deelnemers met stadium 4 niet-kleincellig longcarcinoom (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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Elelta Shiferraw
- Telefoonnummer: 314-209-3659
- E-mail: shiferrawe@eikontx.com
Studie Locaties
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New South Wales
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Frenchs Forest, New South Wales, Australië, 2086
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- Cancer Care Northern Beaches
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Waratah, New South Wales, Australië, 2298
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- Calvary Mater Newcastle Hospital
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Victoria
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Frankston, Victoria, Australië, 3199
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- Peninsula and Southeast Oncology (PASO) Medical
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Saint Albans, Victoria, Australië, 3021
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- Sunshine Hospital - Western Health
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Brussels, België, 1020
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- Centre Hospitalier Universitaire Brugmann
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brazilië, 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, Brazilië, 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, Brazilië, 22250-905
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- Oncoclinicas Rio de Janeiro
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Hamburg, Duitsland, 22087
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- Katholische Marienkrankenhaus gGmbH
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Saxony
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Dresden, Saxony, Duitsland, 01307
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- University Hospital Carl Gustav Carus Dresden
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Athens, Griekenland, 11516
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- Henry Dunant Hospital Center
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Linz, Oostenrijk, 4020
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- Kepler Universitaetsklinikum
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 31-864
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- GCPMED Sp. z o.o., Centrum Medyczne iMed24
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Barcelona, Spanje, 08028
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- Instituto Oncologico Dr. Rosell (IOR)
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Girona, Spanje, 17007
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- Institut Catala D'Oncologia de Girona
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Málaga, Spanje, 29004
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- Hospital Quirónsalud Málaga
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Cadiz
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Jerez de la Frontera, Cadiz, Spanje, 11407
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- Hospital Universitario de Jerez de la Frontera
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Castellón
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Castellon, Castellón, Spanje, 12006
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- Consorci Hospitalari Provincial de Castello
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Malaga
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Málaga, Malaga, Spanje, 29011
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- Hospital Regional Universitario de Malaga
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Alabama
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Daphne, Alabama, Verenigde Staten, 36526
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- Southern Cancer Center, P.C.
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California
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Glendale, California, Verenigde Staten, 91204
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- Los Angeles Cancer Network
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Orange, California, Verenigde Staten, 92868
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- Providence St. Joseph Hospital
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Colorado
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Pueblo, Colorado, Verenigde Staten, 81103
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- Rocky Mountain Cancer Centers, LLP
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Florida
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Doral, Florida, Verenigde Staten, 33172
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- Omnicure Clinical Research
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Plantation, Florida, Verenigde Staten, 33322
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- Florida Clinical Trials Group
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Tamarac, Florida, Verenigde Staten, 33321
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- Florida Clinical Trials Group - Tamarac
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Illinois
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Peoria, Illinois, Verenigde Staten, 61637
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- OSF Saint Francis Medical Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
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- University of New Mexico - Comprehensive Cancer Center
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New York
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Mineola, New York, Verenigde Staten, 11501
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- NYU Langone Hospital Long Island
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New York, New York, Verenigde Staten, 10016
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- NYU Langone Hospital Manhattan
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The Bronx, New York, Verenigde Staten, 10461
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- Jacobi Medical Center - Albert Einstein College of Medicine
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White Plains, New York, Verenigde Staten, 10601
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- White Plains Hospital
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37203
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- Tennessee Oncology
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Texas
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Fort Worth, Texas, Verenigde Staten, 76104
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- The Center for Cancer and Blood Disorders
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Virginia
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Blacksburg, Virginia, Verenigde Staten, 24060
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- Blue Ridge Cancer Center
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Fairfax, Virginia, Verenigde Staten, 22031
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- Virginia Cancer Specialists, PC
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Winchester, Virginia, Verenigde Staten, 22601
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- Shenandoah Oncology P.C.
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Daegu
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Daegu, Daegu, Zuid -Korea, 42415
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- Yeungnam University College of Medicine
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Incheon Gwang'Yeogsi
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Incheon, Incheon Gwang'Yeogsi, Zuid -Korea, 21565
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- Gachon University - Gil Medical Center
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Jeollanam-do
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Hwasun, Jeollanam-do, Zuid -Korea, 58128
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- Chonnam National University Hwasun Hospital (CNUHH)
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Gauteng
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Saxonwold, Gauteng, Zuid-Afrika, 2196
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- The Medical Oncology Centre of Rosebank
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Western Cape
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George, Western Cape, Zuid-Afrika, 6529
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- Task Eden
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: 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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Experimenteel: 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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Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Progression-free survival (PFS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Objective response (OR)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Nishitha Reddy, Eikon Therapeutics
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Carcinoom, niet-kleincellige long
- Aminozuren, peptiden en eiwitten
- Organische chemicaliën
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Anorganische chemicaliën
- Chloorverbindingen
- Stikstofverbindingen
- Coördinatiecomplexen
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamaten
- Aminozuren, zuur
- Aminozuren
- Aminozuren, dicarbonylisch
- Platinumverbindingen
- Pemetrexed
- Carboplatine
- Cisplatine
- pembrolizumab
- 130-nm albumine-gebonden Paclitaxel
- CP -protocol
Andere studie-ID-nummers
- EIK1001-008
- 2025-525013-23-00 (Ctis)
- KEYNOTE-G57 (Andere identificatie: Merck Sharp & Dohme LLC)
- MK-3475-G57 (Andere identificatie: Merck Sharp & Dohme LLC)
- 2025 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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