En sikkerheds- og effektivitetsundersøgelse af EIK1001 i kombination med pembrolizumab og kemoterapi hos deltagere med stadie 4 ikke-småcellet lungekræft. (TeLuRide-008)
Et globalt, multicenter, randomiseret, dobbeltblindt, placebokontrolleret, fase 2/3-studie af EIK1001 i kombination med pembrolizumab og kemoterapi hos deltagere med stadium 4 ikke-småcellet lungekræft (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.
Studieoversigt
Status
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Elelta Shiferraw
- Telefonnummer: 314-209-3659
- E-mail: shiferrawe@eikontx.com
Studiesteder
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New South Wales
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Frenchs Forest, New South Wales, Australien, 2086
- Rekruttering
- Cancer Care Northern Beaches
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Waratah, New South Wales, Australien, 2298
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- Calvary Mater Newcastle Hospital
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Victoria
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Frankston, Victoria, Australien, 3199
- Rekruttering
- Peninsula and Southeast Oncology (PASO) Medical
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Saint Albans, Victoria, Australien, 3021
- Rekruttering
- Sunshine Hospital - Western Health
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Brussels, Belgien, 1020
- Rekruttering
- Centre Hospitalier Universitaire Brugmann
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasilien, 29308-065
- Rekruttering
- Hospital Evangélico de Cachoeiro de Itapemirim
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 40170-110
- Rekruttering
- Nucleo de Oncologia da Bahia
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasilien, 22250-905
- Rekruttering
- Oncoclinicas Rio de Janeiro
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Alabama
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Daphne, Alabama, Forenede Stater, 36526
- Rekruttering
- Southern Cancer Center, P.C.
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California
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Glendale, California, Forenede Stater, 91204
- Rekruttering
- Los Angeles Cancer Network
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Orange, California, Forenede Stater, 92868
- Rekruttering
- Providence St. Joseph Hospital
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Colorado
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Pueblo, Colorado, Forenede Stater, 81103
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Florida
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Doral, Florida, Forenede Stater, 33172
- Rekruttering
- Omnicure Clinical Research
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Plantation, Florida, Forenede Stater, 33322
- Rekruttering
- Florida Clinical Trials Group
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Tamarac, Florida, Forenede Stater, 33321
- Rekruttering
- Florida Clinical Trials Group - Tamarac
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Illinois
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Peoria, Illinois, Forenede Stater, 61637
- Rekruttering
- OSF Saint Francis Medical Center
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- Rekruttering
- University of New Mexico - Comprehensive Cancer Center
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New York
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Mineola, New York, Forenede Stater, 11501
- Rekruttering
- NYU Langone Hospital Long Island
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Langone Hospital Manhattan
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The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Jacobi Medical Center - Albert Einstein College of Medicine
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White Plains, New York, Forenede Stater, 10601
- Rekruttering
- White Plains Hospital
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
- Rekruttering
- The Center for Cancer and Blood Disorders
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Virginia
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Blacksburg, Virginia, Forenede Stater, 24060
- Rekruttering
- Blue Ridge Cancer Center
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists, PC
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Winchester, Virginia, Forenede Stater, 22601
- Rekruttering
- Shenandoah Oncology P.C.
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Athens, Grækenland, 11516
- Rekruttering
- Henry Dunant Hospital Center
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 31-864
- Rekruttering
- GCPMED Sp. z o.o., Centrum Medyczne iMed24
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Barcelona, Spanien, 08028
- Rekruttering
- Instituto Oncologico Dr. Rosell (IOR)
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Girona, Spanien, 17007
- Rekruttering
- Institut Catala D'Oncologia de Girona
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Málaga, Spanien, 29004
- Rekruttering
- Hospital Quirónsalud Málaga
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Cadiz
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Jerez de la Frontera, Cadiz, Spanien, 11407
- Rekruttering
- Hospital Universitario de Jerez de la Frontera
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Castellón
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Castellon, Castellón, Spanien, 12006
- Rekruttering
- Consorci Hospitalari Provincial de Castello
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Malaga
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Málaga, Malaga, Spanien, 29011
- Rekruttering
- Hospital Regional Universitario de Malaga
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Gauteng
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Saxonwold, Gauteng, Sydafrika, 2196
- Rekruttering
- The Medical Oncology Centre of Rosebank
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Western Cape
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George, Western Cape, Sydafrika, 6529
- Rekruttering
- Task Eden
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Daegu
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Daegu, Daegu, Sydkorea, 42415
- Rekruttering
- Yeungnam University College of Medicine
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Incheon Gwang'Yeogsi
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Incheon, Incheon Gwang'Yeogsi, Sydkorea, 21565
- Rekruttering
- Gachon University - Gil Medical Center
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Jeollanam-do
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Hwasun, Jeollanam-do, Sydkorea, 58128
- Rekruttering
- Chonnam National University Hwasun Hospital (CNUHH)
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Hamburg, Tyskland, 22087
- Rekruttering
- Katholische Marienkrankenhaus gGmbH
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Rekruttering
- University Hospital Carl Gustav Carus Dresden
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Linz, Østrig, 4020
- Rekruttering
- Kepler Universitaetsklinikum
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: 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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Eksperimentel: 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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Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progression-free survival (PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objective response (OR)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Nishitha Reddy, Eikon Therapeutics
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Karcinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinationskomplekser
- Guanine
- Hypoxanthines
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sur
- Aminosyrer
- Aminosyrer, dicarboxylic
- Platinforbindelser
- Pemetrexed
- Carboplatin
- Cisplatin
- pembrolizumab
- 130-nm albuminbundet paclitaxel
- CP -protokol
Andre undersøgelses-id-numre
- EIK1001-008
- 2025-525013-23-00 (Ctis)
- KEYNOTE-G57 (Anden identifikator: Merck Sharp & Dohme LLC)
- MK-3475-G57 (Anden identifikator: Merck Sharp & Dohme LLC)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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