Studio di sicurezza ed efficacia di EIK1001 in combinazione con pembrolizumab e chemioterapia in partecipanti con carcinoma polmonare non a piccole cellule in stadio 4. (TeLuRide-008)
Studio globale, multicentrico, randomizzato, in doppio cieco, controllato con placebo, di Fase 2/3 su EIK1001 in combinazione con Pembrolizumab e chemioterapia in partecipanti con carcinoma polmonare non a piccole cellule in stadio 4 (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.
Panoramica dello studio
Stato
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Elelta Shiferraw
- Numero di telefono: 314-209-3659
- Email: shiferrawe@eikontx.com
Luoghi di studio
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New South Wales
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Frenchs Forest, New South Wales, Australia, 2086
- Reclutamento
- Cancer Care Northern Beaches
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Waratah, New South Wales, Australia, 2298
- Reclutamento
- Calvary Mater Newcastle Hospital
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Victoria
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Frankston, Victoria, Australia, 3199
- Reclutamento
- Peninsula and Southeast Oncology (PASO) Medical
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Saint Albans, Victoria, Australia, 3021
- Reclutamento
- Sunshine Hospital - Western Health
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Linz, Austria, 4020
- Reclutamento
- Kepler Universitaetsklinikum
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Brussels, Belgio, 1020
- Reclutamento
- Centre Hospitalier Universitaire Brugmann
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Espírito Santo
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Cachoeiro de Itapemirim, Espírito Santo, Brasile, 29308-065
- Reclutamento
- Hospital Evangélico de Cachoeiro de Itapemirim
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Estado de Bahia
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Salvador, Estado de Bahia, Brasile, 40170-110
- Reclutamento
- Nucleo de Oncologia da Bahia
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasile, 22250-905
- Reclutamento
- Oncoclinicas Rio de Janeiro
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Daegu
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Daegu, Daegu, Corea del Sud, 42415
- Reclutamento
- Yeungnam University College of Medicine
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Incheon Gwang'Yeogsi
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Incheon, Incheon Gwang'Yeogsi, Corea del Sud, 21565
- Reclutamento
- Gachon University - Gil Medical Center
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Jeollanam-do
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Hwasun, Jeollanam-do, Corea del Sud, 58128
- Reclutamento
- Chonnam National University Hwasun Hospital (CNUHH)
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Hamburg, Germania, 22087
- Reclutamento
- Katholische Marienkrankenhaus gGmbH
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Saxony
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Dresden, Saxony, Germania, 01307
- Reclutamento
- University Hospital Carl Gustav Carus Dresden
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Athens, Grecia, 11516
- Reclutamento
- Henry Dunant Hospital Center
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 31-864
- Reclutamento
- GCPMED Sp. z o.o., Centrum Medyczne iMed24
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Barcelona, Spagna, 08028
- Reclutamento
- Instituto Oncologico Dr. Rosell (IOR)
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Girona, Spagna, 17007
- Reclutamento
- Institut Catala D'Oncologia de Girona
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Málaga, Spagna, 29004
- Reclutamento
- Hospital Quirónsalud Málaga
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Cadiz
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Jerez de la Frontera, Cadiz, Spagna, 11407
- Reclutamento
- Hospital Universitario de Jerez de la Frontera
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Castellón
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Castellon, Castellón, Spagna, 12006
- Reclutamento
- Consorci Hospitalari Provincial de Castello
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Malaga
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Málaga, Malaga, Spagna, 29011
- Reclutamento
- Hospital Regional Universitario de Malaga
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Alabama
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Daphne, Alabama, Stati Uniti, 36526
- Reclutamento
- Southern Cancer Center, P.C.
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California
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Glendale, California, Stati Uniti, 91204
- Reclutamento
- Los Angeles Cancer Network
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Orange, California, Stati Uniti, 92868
- Reclutamento
- Providence St. Joseph Hospital
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Colorado
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Pueblo, Colorado, Stati Uniti, 81103
- Reclutamento
- Rocky Mountain Cancer Centers, LLP
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Florida
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Doral, Florida, Stati Uniti, 33172
- Reclutamento
- Omnicure Clinical Research
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Plantation, Florida, Stati Uniti, 33322
- Reclutamento
- Florida Clinical Trials Group
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Tamarac, Florida, Stati Uniti, 33321
- Reclutamento
- Florida Clinical Trials Group - Tamarac
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Illinois
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Peoria, Illinois, Stati Uniti, 61637
- Reclutamento
- OSF Saint Francis Medical Center
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Reclutamento
- University of New Mexico - Comprehensive Cancer Center
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New York
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Mineola, New York, Stati Uniti, 11501
- Reclutamento
- NYU Langone Hospital Long Island
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New York, New York, Stati Uniti, 10016
- Reclutamento
- NYU Langone Hospital Manhattan
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The Bronx, New York, Stati Uniti, 10461
- Reclutamento
- Jacobi Medical Center - Albert Einstein College of Medicine
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White Plains, New York, Stati Uniti, 10601
- Reclutamento
- White Plains Hospital
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Tennessee Oncology
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Texas
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Fort Worth, Texas, Stati Uniti, 76104
- Reclutamento
- The Center for Cancer and Blood Disorders
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Virginia
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Blacksburg, Virginia, Stati Uniti, 24060
- Reclutamento
- Blue Ridge Cancer Center
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Fairfax, Virginia, Stati Uniti, 22031
- Reclutamento
- Virginia Cancer Specialists, PC
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Winchester, Virginia, Stati Uniti, 22601
- Reclutamento
- Shenandoah Oncology P.C.
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Gauteng
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Saxonwold, Gauteng, Sud Africa, 2196
- Reclutamento
- The Medical Oncology Centre of Rosebank
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Western Cape
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George, Western Cape, Sud Africa, 6529
- Reclutamento
- Task Eden
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: 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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Sperimentale: 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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Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression-free survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Objective response (OR)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Nishitha Reddy, Eikon Therapeutics
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie delle vie respiratorie
- Malattie polmonari
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Neoplasie polmonari
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Carcinoma, polmone non a piccole cellule
- Aminoacidi, peptidi e proteine
- Prodotti chimici organici
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Prodotti chimici inorganici
- Composti di cloro
- Composti di azoto
- Complessi di coordinamento
- Guanina
- Ipossantine
- Purinoni
- Purine
- Glutammati
- Aminoacidi, acido
- Aminoacidi
- Aminoacidi, dicarbossilico
- Composti di platino
- Pemetrexed
- Carboplatino
- Cisplatino
- pembrolizumab
- Paclitaxel diretto da 130 nm su albumina
- Protocollo CP
Altri numeri di identificazione dello studio
- EIK1001-008
- 2025-525013-23-00 (Ctis)
- KEYNOTE-G57 (Altro identificatore: Merck Sharp & Dohme LLC)
- MK-3475-G57 (Altro identificatore: Merck Sharp & Dohme LLC)
- 2025 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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