Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)

PHASE3RecruitingINTERVENTIONAL
Enrollment

756

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

September 30, 2029

Conditions
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Interventions
BIOLOGICAL

eftilagimod alfa

30 mg of efti every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total

DRUG

carboplatin plus paclitaxel

For participants with squamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: carboplatin area under the curve (AUC) 5 or 6 in combination with paclitaxel 175 mg/m2 or 200 mg/m2

DRUG

cisplatin or carboplatin + pemetrexed

For participants with nonsquamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: cisplatin 75 mg/m2 or carboplatin AUC 5 or 6 in combination with pemetrexed 500 mg/m2. After the initial 4 cycles, pemetrexed 500 mg/m2 maintenance therapy will be administered every 3 weeks

BIOLOGICAL

pembrolizumab (KEYTRUDA®)

200 mg pembrolizumab (KEYTRUDA®) every 3 weeks i.v. for up to approximately 24 months

OTHER

Placebo

efti-matching placebo every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total

Trial Locations (105)

Unknown

RECRUITING

Lyell McEwin Hospital, Elizabeth Vale

RECRUITING

Greenslopes Private Hospital, Greenslopes

RECRUITING

The Alfred Hospital, Melbourne

RECRUITING

Tasman Oncology Research Ltd, Southport

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St John of God Subiaco Hospital, Subiaco

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Royal Darwin Hospital, Tiwi

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Calvary Mater Newcastle, Waratah

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Cancer Care Wollongong Pty Limited, Wollongong

RECRUITING

Landeskrankenhaus-Universitätsklinikum Graz, KLinische Abteilung für Pulmonologie, Graz

RECRUITING

Vienna General Hospital, Vienna

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Antwerp University Hospital, Antwerp

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Algemeen Ziekenhuis Maria Middelares, Ghent

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Clinique et Maternité Sainte-Elisabeth, Namur

RECRUITING

Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich

RECRUITING

"Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD", Gabrovo

RECRUITING

MHAT Uni Hospital OOD, Panagyurishte

RECRUITING

Complex Oncology Center Ruse, Rousse

RECRUITING

Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia

RECRUITING

Brampton Civic Hospital, Brampton

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McGill University - Jewish General Hospital (JGH) - Lady Davis Institute for Medical Research, Montreal

RECRUITING

Unite de recherche clinique du CISSS des Laurentides, Saint-Jérôme

RECRUITING

Centro de Oncologia de Precision, Las Condes

RECRUITING

Facultad Odontología Unipac, Santiago

RECRUITING

Klinički Bolnički Centar Osijek, Osijek

RECRUITING

Klinicka Bolnica Centar - Sestre Milosrdnice - Klinika Za Tumore (University Hospital for Tumors), Zagreb

RECRUITING

Klinički Bolnički Centar Sestre Milosrdnice, Zagreb

RECRUITING

Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac, Zagreb

RECRUITING

High-tech Hospital Med Center, Batumi

RECRUITING

High Technology Medical Center, University Clinic, Tbilisi

RECRUITING

Institute of Clinical Oncology, Tbilisi

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Mardaleishvili Medical Centre, Tbilisi

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Evangelische Lungenklinik Berlin, Berlin

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Krankenhaus Nordwest, Frankfurt am Main

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Krankenhaus Martha-Maria Halle-Dölau, Halle

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Gemeinschaftspraxis Dr Klemper, Mainz

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Gemeinschaftspraxis für Hämatologie und Onkologie, Münster

RECRUITING

Robert-Bosch-Krankenhaus, Stuttgart

RECRUITING

"General Hospital of Athens Laiko", Athens

RECRUITING

Sotiria Chest Diseases Hospital, Athens

RECRUITING

University of Thessaly- General University Hospital of Larissa, Larissa

RECRUITING

University of Patras - Rio Regional University Hospital, Pátrai

RECRUITING

Metropolitan Hospital, Department of Oncology, Piraeus

RECRUITING

Bioclinic of Thessaloniki, Thessaloniki

RECRUITING

Interbalkan Medical Center of Thessaloniki, Thessaloniki

RECRUITING

St. Luke's Hospital S.A., Thessaloniki

RECRUITING

HCG Cancer Centre - Double Road (Bangalore Institute of Oncology (BIO)), Bangalore

RECRUITING

Geri Care Hospital T.Nagar, Chennai

RECRUITING

Voluntary Health Services Hospital, Chennai

RECRUITING

Chittaranjan National Cancer Institute, Kolkata

RECRUITING

Maulana Azad Medical College, New Delhi

RECRUITING

Sunact Cancer Institute Pvt. Ltd., Thāne

RECRUITING

Regional Cancer Centre Thiruvananthapuram, Thiruvananthapuram

RECRUITING

Tata Memorial Centre - Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi

RECRUITING

Beaumont Hospital, Dublin

RECRUITING

Mater Misericordiae University Hospital, Dublin

RECRUITING

Tallaght University Hospital, Dublin

RECRUITING

Azienda Ospedaliera San Giuseppe Moscati, Avellino

RECRUITING

Centro di Riferimento Oncologico (CRO), Aviano

RECRUITING

Istituto per la Ricerca e la Cura del Cancro (IRCC) - Istituto di Candiolo, Candiolo

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

RECRUITING

"Istituto Nazionale Tumori (INT) Fondazione G. Pascale di Napoli", Napoli

RECRUITING

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia, Perugia

RECRUITING

Azienda Ospedaliera Santa Maria di Terni, Terni

RECRUITING

Latvian Oncology Center, Riga

RECRUITING

Paula Stradiņa Klīniskā Universitātes Slimnīca, Riga

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas

RECRUITING

Nacionalinis Vezio Institutas, Vilnius

RECRUITING

Hospital Tengku Ampuan Afzan, Kuantan

RECRUITING

Hospital Umum Sarawak - Clinical Research Centre, Kuching

RECRUITING

Gleneagles Medical Centre - Penang, Pulau Pinang

RECRUITING

Hospital Pulau Pinang, Pulau Pinang

RECRUITING

Szpital Morski im. PCK (Maritime Hospital) (Gdynskie Centrum Onkologii), Gdynia

RECRUITING

"Przychodnia Lekarska KOMED", Konin

RECRUITING

Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi, Lodz

RECRUITING

IP Clinic Sp. z o.o., Lodz

RECRUITING

Hospital Garcia de Orta, EPE, Almada

RECRUITING

Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente, Lisbon

RECRUITING

Unidade Local de Saude de Loures - Odivelas, E. P. E., Loures

RECRUITING

Centrul Medical Medicover Victoria, Bucharest

RECRUITING

Spitalul Memorial Healthcare International, Bucharest

RECRUITING

Onco Clinic Consult SA, Craiova

RECRUITING

OncoLab, Craiova

RECRUITING

Victoria Hospital - Centrul de Oncologie Euroclinic SRL, Iași

RECRUITING

Ovidius Clinical Hospital S.R.L., Ovidiu

RECRUITING

Hospital Universitari Germans Trias i Pujol, Badalona

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

RECRUITING

Instituto Oncologico Dr. Rosell - Hospital Universitari Quiron Dexeus Location, Barcelona

RECRUITING

Hospital Universitario Reina Sofía, Córdoba

RECRUITING

HM Universitario Sanchinarro, Madrid

RECRUITING

Hospital Regional Universitario de Málaga - Hospital General, Málaga

RECRUITING

Hospital Universitario Central de Asturias, Oviedo

RECRUITING

Parc Tauli Hospital Universitari, Sabadell

RECRUITING

Hospital Universitario Virgen Macarena, Seville

RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

RECRUITING

"Hospital Clínico Universitario Lozano Blesa", Zaragoza

RECRUITING

Gulhane Egitim ve Arastirma Hastanesi, Ankara

RECRUITING

Hacettepe Universitesi Kanser Enstitusu (Hacettepe University Cancer Institute), Ankara

RECRUITING

Istanbul Oncology Hospital, Cevizli

RECRUITING

Bahcelievler Memorial Hospital, Istanbul

RECRUITING

T.C. S.B. Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

RECRUITING

Sakarya Universitesi Tıp Fakultesi Dekanligi, Sakarya

RECRUITING

University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham, Birmingham

RECRUITING

The Royal Surrey County Hospital NHS Foundation Trust, Guildford

RECRUITING

The Christie NHS Foundation Trust - Christie Hospital, Manchester

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Immutep S.A.S.

INDUSTRY