TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination With Pembrolizumab (PD-1 Antagonist) and Chemotherapy.

Status: Recruiting
Location: See all (90) locations...
Intervention Type: Biological, Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC). Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ Participants may be enrolled if they meet all of the following criteria at screening:

• Willing to give written informed consent and to comply with the protocol.

• Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) non-small cell lung cancer (NSCLC) not amenable to curative treatment or locally available oncogenic driver mutation-based first-line therapy, treatment naïve for systemic therapy given for advanced/metastatic disease.

• Archival tumor tissue sample or newly obtained core, or excisional biopsy of a tumor lesion not previously irradiated has been provided. Details pertaining to tumor tissue submission can be found in the Laboratory Manual.

• Availability of programmed death-ligand 1 (PD-L1) biomarker result from central laboratory, using the Food and Drug Administration (FDA) approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).

• Be ≥ 18 years of age on the day of signing the informed consent.

• Participants capable of producing sperm must follow specific contraception guidelines during and after the trial intervention period. The required contraception duration varies by drug. Participants must refrain from donating sperm and either remain abstinent or use condoms with an additional contraceptive method during intercourse with a nonpregnant partner. Contraceptive measures must adhere to local regulations, with stricter local label requirements taking precedence over the trial's guidelines.

• A participant of childbearing potential (POCBP) is eligible if they are not pregnant, confirmed by a negative pregnancy test before the first trial dose. They must not breastfeed during the trial or for a defined duration after the last dose of each drug. POCBPs must use highly effective contraception, with low user dependency or long-term abstinence during and after the trial intervention, and refrain from egg donation or storage. The required contraception duration varies by drug. Local contraception regulations must be followed.

• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.

• Expected survival \> 3 months.

⁃ Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by site.

⁃ Participants must have recovered from all AEs due to previous anticancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 ≤ Grade 1 or baseline. Participants with CTCAE ≤ Grade 2 neuropathy, alopecia, and elevated transaminases in case of liver metastases may be eligible.

⁃ Participants who received major surgery prior to trial start must have recovered adequately from the toxicity and/or complications from the intervention prior to starting trial treatment.

⁃ Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.

⁃ Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening and have completed curative antiviral therapy at least 4 weeks prior to randomization.

⁃ Human immunodeficiency virus (HIV) infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease.

⁃ Adequate organ function.

Locations
Other Locations
Australia
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Greenslopes Private Hospital
RECRUITING
Greenslopes
The Alfred Hospital
RECRUITING
Melbourne
Tasman Oncology Research Ltd
RECRUITING
Southport
St John of God Subiaco Hospital
RECRUITING
Subiaco
Calvary Mater Newcastle
RECRUITING
Waratah
Cancer Care Wollongong Pty Limited
RECRUITING
Wollongong
Austria
Vienna General Hospital
RECRUITING
Vienna
Belgium
Antwerp University Hospital
RECRUITING
Antwerp
Algemeen Ziekenhuis Maria Middelares
RECRUITING
Ghent
Clinique et Maternité Sainte-Elisabeth
RECRUITING
Namur
Bulgaria
Multiprofile Hospital for Active Treatment - Dobrich AD
RECRUITING
Dobrich
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
RECRUITING
Gabrovo
MHAT Uni Hospital OOD
RECRUITING
Panagyurishte
Complex Oncology Center Ruse
RECRUITING
Rousse
Multiprofile Hospital for Active Treatment Serdika EOOD
RECRUITING
Sofia
Canada
Brampton Civic Hospital
RECRUITING
Brampton
McGill University - Jewish General Hospital (JGH) - Lady Davis Institute for Medical Research
RECRUITING
Montreal
Unite de recherche clinique du CISSS des Laurentides
RECRUITING
Saint-jérôme
Chile
Facultad Odontología Unipac
RECRUITING
Santiago
Croatia
Klinički Bolnički Centar Osijek
RECRUITING
Osijek
Klinicka Bolnica Centar - Sestre Milosrdnice - Klinika Za Tumore (University Hospital for Tumors)
RECRUITING
Zagreb
Klinički Bolnički Centar Sestre Milosrdnice
RECRUITING
Zagreb
Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac
RECRUITING
Zagreb
Georgia
High-tech Hospital Med Center
RECRUITING
Batumi
High Technology Medical Center, University Clinic
RECRUITING
Tbilisi
Institute of Clinical Oncology
RECRUITING
Tbilisi
Mardaleishvili Medical Centre
RECRUITING
Tbilisi
Germany
Krankenhaus Nordwest
RECRUITING
Frankfurt Am Main
Krankenhaus Martha-Maria Halle-Dölau
RECRUITING
Halle
Gemeinschaftspraxis Dr Klemper
RECRUITING
Mainz
Gemeinschaftspraxis für Hämatologie und Onkologie
RECRUITING
Münster
Robert-Bosch-Krankenhaus
RECRUITING
Stuttgart
Greece
General Hospital of Athens Laiko
RECRUITING
Athens
Sotiria Chest Diseases Hospital
RECRUITING
Athens
University of Thessaly- General University Hospital of Larissa
RECRUITING
Larissa
University of Patras - Rio Regional University Hospital
RECRUITING
Pátrai
Metropolitan Hospital, Department of Oncology
RECRUITING
Piraeus
Bioclinic of Thessaloniki
RECRUITING
Thessaloniki
Interbalkan Medical Center of Thessaloniki
RECRUITING
Thessaloniki
St. Luke's Hospital S.A.
RECRUITING
Thessaloniki
India
HCG Cancer Centre - Double Road (Bangalore Institute of Oncology (BIO))
RECRUITING
Bangalore
Geri Care Hospital T.Nagar
RECRUITING
Chennai
Chittaranjan National Cancer Institute
RECRUITING
Kolkata
Maulana Azad Medical College
RECRUITING
New Delhi
Sunact Cancer Institute Pvt. Ltd.
RECRUITING
Thāne
Regional Cancer Centre Thiruvananthapuram
RECRUITING
Thiruvananthapuram
Tata Memorial Centre - Mahamana Pandit Madan Mohan Malaviya Cancer Centre
RECRUITING
Varanasi
Ireland
Beaumont Hospital
RECRUITING
Dublin
Mater Misericordiae University Hospital
RECRUITING
Dublin
Tallaght University Hospital
RECRUITING
Dublin
Italy
Azienda Ospedaliera San Giuseppe Moscati
RECRUITING
Avellino
Centro di Riferimento Oncologico (CRO)
RECRUITING
Aviano
Istituto per la Ricerca e la Cura del Cancro (IRCC) - Istituto di Candiolo
RECRUITING
Candiolo
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Istituto Nazionale Tumori (INT) Fondazione G. Pascale di Napoli
RECRUITING
Napoli
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia
RECRUITING
Perugia
Azienda Ospedaliera Santa Maria di Terni
RECRUITING
Terni
Latvia
Latvian Oncology Center
RECRUITING
Riga
Paula Stradiņa Klīniskā Universitātes Slimnīca
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
RECRUITING
Kaunas
Nacionalinis Vezio Institutas
RECRUITING
Vilnius
Malaysia
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Hospital Umum Sarawak - Clinical Research Centre
RECRUITING
Kuching
Gleneagles Medical Centre - Penang
RECRUITING
Pulau Pinang
Hospital Pulau Pinang
RECRUITING
Pulau Pinang
Poland
Szpital Morski im. PCK (Maritime Hospital) (Gdynskie Centrum Onkologii)
RECRUITING
Gdynia
Przychodnia Lekarska KOMED
RECRUITING
Konin
Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi
RECRUITING
Lodz
IP Clinic Sp. z o.o.
RECRUITING
Lodz
Portugal
Hospital Garcia de Orta, EPE
RECRUITING
Almada
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
RECRUITING
Lisbon
Unidade Local de Saude de Loures - Odivelas, E. P. E.
RECRUITING
Loures
Romania
Centrul Medical Medicover Victoria
RECRUITING
Bucharest
Spitalul Memorial Healthcare International
RECRUITING
Bucharest
Onco Clinic Consult SA
RECRUITING
Craiova
OncoLab
RECRUITING
Craiova
Victoria Hospital - Centrul de Oncologie Euroclinic SRL
RECRUITING
Iași
Ovidius Clinical Hospital S.R.L.
RECRUITING
Ovidiu
Spain
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Instituto Oncologico Dr. Rosell - Hospital Universitari Quiron Dexeus Location
RECRUITING
Barcelona
Hospital Universitario Reina Sofía
RECRUITING
Córdoba
HM Universitario Sanchinarro
RECRUITING
Madrid
Hospital Regional Universitario de Málaga - Hospital General
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Parc Tauli Hospital Universitari
RECRUITING
Sabadell
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
Chief Scientific Officer
enquiries@immutep.com
+49 30 88716843
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2029-09
Participants
Target number of participants: 756
Treatments
Experimental: efti + Standard of Care arm
Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Placebo_comparator: Placebo + Standard of Care arm
Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Immutep S.A.S.

This content was sourced from clinicaltrials.gov

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