En sikkerhets- og effektstudie av EIK1001 i kombinasjon med pembrolizumab og kjemoterapi hos deltakere med stadium 4 ikke-småcellet lungekreft. (TeLuRide-008)
En global, multikenter, randomisert, dobbeltblind, placebokontrollert, fase 2/3-studie av EIK1001 i kombinasjon med pembrolizumab og kjemoterapi hos deltakere med stadium 4 ikke-småcellet lungekreft (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.
Studieoversikt
Status
Detaljert 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).
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Elelta Shiferraw
- Telefonnummer: 314-209-3659
- E-post: shiferrawe@eikontx.com
Studiesteder
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New South Wales
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Frenchs Forest, New South Wales, Australia, 2086
- Rekruttering
- Cancer Care Northern Beaches
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Waratah, New South Wales, Australia, 2298
- Rekruttering
- Calvary Mater Newcastle Hospital
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Victoria
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Frankston, Victoria, Australia, 3199
- Rekruttering
- Peninsula and Southeast Oncology (PASO) Medical
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Saint Albans, Victoria, Australia, 3021
- Rekruttering
- Sunshine Hospital - Western Health
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Brussels, Belgia, 1020
- Rekruttering
- Centre Hospitalier Universitaire Brugmann
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasil, 29308-065
- Rekruttering
- Hospital Evangélico de Cachoeiro de Itapemirim
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 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, Brasil, 22250-905
- Rekruttering
- Oncoclinicas Rio de Janeiro
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Alabama
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Daphne, Alabama, Forente stater, 36526
- Rekruttering
- Southern Cancer Center, P.C.
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California
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Glendale, California, Forente stater, 91204
- Rekruttering
- Los Angeles Cancer Network
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Orange, California, Forente stater, 92868
- Rekruttering
- Providence St. Joseph Hospital
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Colorado
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Pueblo, Colorado, Forente stater, 81103
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Florida
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Doral, Florida, Forente stater, 33172
- Rekruttering
- Omnicure Clinical Research
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Plantation, Florida, Forente stater, 33322
- Rekruttering
- Florida Clinical Trials Group
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Tamarac, Florida, Forente stater, 33321
- Rekruttering
- Florida Clinical Trials Group - Tamarac
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Illinois
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Peoria, Illinois, Forente stater, 61637
- Rekruttering
- OSF Saint Francis Medical Center
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87102
- Rekruttering
- University of New Mexico - Comprehensive Cancer Center
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New York
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Mineola, New York, Forente stater, 11501
- Rekruttering
- NYU Langone Hospital Long Island
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New York, New York, Forente stater, 10016
- Rekruttering
- NYU Langone Hospital Manhattan
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The Bronx, New York, Forente stater, 10461
- Rekruttering
- Jacobi Medical Center - Albert Einstein College of Medicine
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White Plains, New York, Forente stater, 10601
- Rekruttering
- White Plains Hospital
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology
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Texas
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Fort Worth, Texas, Forente stater, 76104
- Rekruttering
- The Center for Cancer and Blood Disorders
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Virginia
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Blacksburg, Virginia, Forente stater, 24060
- Rekruttering
- Blue Ridge Cancer Center
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Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists, PC
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Winchester, Virginia, Forente stater, 22601
- Rekruttering
- Shenandoah Oncology P.C.
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Athens, Hellas, 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, Spania, 08028
- Rekruttering
- Instituto Oncologico Dr. Rosell (IOR)
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Girona, Spania, 17007
- Rekruttering
- Institut Catala D'Oncologia de Girona
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Málaga, Spania, 29004
- Rekruttering
- Hospital Quirónsalud Málaga
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Cadiz
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Jerez de la Frontera, Cadiz, Spania, 11407
- Rekruttering
- Hospital Universitario de Jerez de la Frontera
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Castellón
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Castellon, Castellón, Spania, 12006
- Rekruttering
- Consorci Hospitalari Provincial de Castello
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Malaga
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Málaga, Malaga, Spania, 29011
- Rekruttering
- Hospital Regional Universitario de Malaga
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Daegu
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Daegu, Daegu, Sør -Korea, 42415
- Rekruttering
- Yeungnam University College of Medicine
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Incheon Gwang'Yeogsi
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Incheon, Incheon Gwang'Yeogsi, Sør -Korea, 21565
- Rekruttering
- Gachon University - Gil Medical Center
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Jeollanam-do
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Hwasun, Jeollanam-do, Sør -Korea, 58128
- Rekruttering
- Chonnam National University Hwasun Hospital (CNUHH)
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Gauteng
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Saxonwold, Gauteng, Sør-Afrika, 2196
- Rekruttering
- The Medical Oncology Centre of Rosebank
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Western Cape
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George, Western Cape, Sør-Afrika, 6529
- Rekruttering
- Task Eden
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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, Østerrike, 4020
- Rekruttering
- Kepler Universitaetsklinikum
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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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Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Nishitha Reddy, Eikon Therapeutics
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sure
- Aminosyrer
- Aminosyrer, dikarboksyl
- Platinumforbindelser
- Pemetrexed
- Karboplatin
- Cisplatin
- pembrolizumab
- 130-nm albuminbundet paclitaxel
- CP -protokoll
Andre studie-ID-numre
- EIK1001-008
- 2025-525013-23-00 (Ctis)
- KEYNOTE-G57 (Annen identifikator: Merck Sharp & Dohme LLC)
- MK-3475-G57 (Annen identifikator: Merck Sharp & Dohme LLC)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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