AzTrials
AzTrials

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT06726265

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)

A Phase 3 study testing eftilagimod alfa, carboplatin plus paclitaxel and cisplatin or carboplatin + pemetrexed in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Immutep S.A.S. at 147 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
eftilagimod alfa, carboplatin plus paclitaxel and cisplatin or carboplatin + pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
756 participants
Where
147 sitesin 27 countries
Study dates
21 Mar 2025to Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Participants assigned male at birth 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 participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease.
  • Adequate organ function.

Who cannot join

  • Participants are to be excluded from the trial at the time of screening for any of the following reasons:
  • Is expected to require any other form of systemic or localized antineoplastic therapy (other than the trial treatment) while on trial (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection).
  • Received prior radiotherapy within 2 weeks of start of trial intervention, or has radiation-related toxicities, requiring corticosteroids.
  • Participants whose tumor harbors any of the following actionable molecular alterations:
  • Epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation
  • Anaplastic lymphoma kinase (ALK) gene fusion positive (ALK translocation)
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  • c-ROS oncogene 1 (ROS1) translocation
  • For any indication has received any of the following therapies
  • within 3 weeks prior to cycle 1 day 1: systemic cytotoxic chemotherapy, targeted small molecule therapy (e.g. kinase inhibitors), biological therapy, any other systemic cancer therapy or had major surgery;
  • within 4 weeks prior to cycle 1 day 1 has been treated with an investigational agent or has used an investigational device, or is still a participant in the active phase of an investigational trial;
  • within 6 months prior to cycle1 day 1 received lung radiation therapy of >30 Gray (Gy).
  • Has received any treatment as part of adjuvant, neoadjuvant therapy or definitive chemoradiation for the treatment of NSCLC within 12 months prior to the diagnosis of advanced/metastatic disease.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX40, CD137) or Lymphocyte Activation Gene 3 (LAG-3) targeting therapy (e.g., anti-LAG-3 antibodies). Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent for nonmetastatic resectable NSCLC (e.g. in the neoadjuvant or adjuvant setting) or following definitive chemoradiation, is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
  • Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during trial screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of trial intervention.
  • Active infection requiring parenteral systemic therapy within 4 weeks prior to cycle 1 day 1 and/or significant acute or chronic infection in screening and/or on cycle 1 day 1.
  • Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥ 2, atrial fibrillation > Grade 2 not controlled by a pacemaker, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association (NYHA) III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial intervention.
  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
  • HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • History of allogenic tissue/solid organ transplant.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has hypersensitivity to eftilagimod alfa and/or pembrolizumab (≥Grade 3) and/or any of its excipients.
  • Has hypersensitivity to any component of planned platinum-based doublet chemotherapy and/or any of its excipients.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of trial intervention. Administration of killed vaccines is allowed
  • Has a life-threatening illness unrelated to cancer.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.

Trial locations and contacts

147 sites in 27 countries.

147 sites in 27 countries

Spain14 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • Instituto Oncologico Dr. Rosell - Hospital Universitari Quiron Dexeus Location

    Barcelona

  • Hospital Universitario Reina Sofía

    Córdoba

  • HM Universitario Sanchinarro

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga

  • Hospital Universitario Central de Asturias

    Oviedo

  • Parc Tauli Hospital Universitari

    Sabadell

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Clinico Universitario de Valencia

    Valencia

  • Hospital Clínico Universitario "Lozano Blesa"

    Zaragoza

Other trials in Spain

Germany13 sites

  • Klinikum St. Marien

    Amberg

  • Klinikum Augsburg

    Augsburg

  • HELIOS Klinikum Bad Saarow

    Bad Saarow

  • Evangelische Lungenklinik Berlin

    Berlin

  • Universitätsklinikum Köln

    Cologne

  • Agaplesion Medizinisches Versorgungszentrum - Frankfurt gGmbH

    Frankfurt

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Krankenhaus Nordwest

    Frankfurt am Main

  • Asklepios Fachkliniken München-Gauting

    Gauting

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle

  • Facharztzentrum Eppendorf

    Hamburg

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster

  • Robert-Bosch-Krankenhaus

    Stuttgart

Other trials in Germany

Turkey (Türkiye)11 sites

  • Adana Medical Park Seyhan Hospital

    Adana

  • Adana Sehir Training and Research Hospital

    Adana

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    Ankara

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara

  • Hacettepe Universitesi Kanser Enstitusu (Hacettepe University Cancer Institute)

    Ankara

  • Uludağ Üniversitesi Tıp Fakültesi

    Bursa

  • Istanbul Oncology Hospital

    Cevizli

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane

    Edirne

  • Bahcelievler Memorial Hospital

    Istanbul

  • T.C. S.B. Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul

  • Sakarya Universitesi Tıp Fakultesi Dekanligi

    Sakarya

Other trials in Turkey (Türkiye)

India9 sites

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

    Bangalore

  • All India Institute of Medical Sciences (AIIMS) - Bhubaneswar

    Bhubaneswar

  • Geri Care Hospital T.Nagar

    Chennai

  • Voluntary Health Services Hospital

    Chennai

  • Chittaranjan National Cancer Institute

    Kolkata

  • Maulana Azad Medical College

    New Delhi

  • Sunact Cancer Institute Pvt. Ltd.

    Thane

  • Regional Cancer Centre Thiruvananthapuram

    Thiruvananthapuram

  • Tata Memorial Centre - Mahamana Pandit Madan Mohan Malaviya Cancer Centre

    Varanasi

Other trials in India

Australia8 sites

  • Lyell McEwin Hospital

    Elizabeth Vale

  • Greenslopes Private Hospital

    Greenslopes

  • The Alfred Hospital

    Melbourne

  • Tasman Oncology Research Ltd

    Southport

  • St John of God Subiaco Hospital

    Subiaco

  • Royal Darwin Hospital

    Tiwi

  • Calvary Mater Newcastle

    Waratah

  • Cancer Care Wollongong Pty Limited

    Wollongong

Other trials in Australia

Brazil8 sites

  • Universidade de Caxias do Sul

    Caxias do Sul

  • Centro Integrado de Oncologia de Curitiba - CIONC

    Curitiba

  • Cetus Oncologia Hospital Dia - Belo Horizonte

    Horizonte

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí

  • Hospital Nossa Senhora da Conceicao (HNSC)

    Porto Alegre

  • Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre

  • Hospital Beneficencia Portuguesa - Mirante

    São Paulo

  • Hospital Santa Rita - Vitoria

    Vitória

Other trials in Brazil

Greece8 sites

  • General Hospital of Athens "Laiko"

    Athens

  • Sotiria Chest Diseases Hospital

    Athens

  • University of Thessaly- General University Hospital of Larissa

    Larissa

  • University of Patras - Rio Regional University Hospital

    Pátrai

  • Metropolitan Hospital, Department of Oncology

    Piraeus

  • Bioclinic of Thessaloniki

    Thessaloniki

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki

  • St. Luke's Hospital S.A.

    Thessaloniki

Other trials in Greece

Italy8 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino

  • Centro di Riferimento Oncologico (CRO)

    Aviano

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

    Candiolo

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

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

    Naples

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Perugia

  • Arcispedale Santa Maria Nuova

    Reggio Emilia

  • Azienda Ospedaliera Santa Maria di Terni

    Terni

Other trials in Italy

Portugal6 sites

  • Hospital Garcia de Orta, EPE

    Almada

  • Hospital CUF Descobertas

    Lisbon

  • Hospital Lusíadas Lisboa

    Lisbon

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

    Lisbon

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

    Loures

  • Instituto Português Oncologia do Porto Francisco Gentil, EPE

    Porto

Other trials in Portugal

Romania6 sites

  • Centrul Medical Medicover Victoria

    Bucharest

  • Spitalul Memorial Healthcare International

    Bucharest

  • Onco Clinic Consult SA

    Craiova

  • OncoLab

    Craiova

  • Victoria Hospital - Centrul de Oncologie Euroclinic SRL

    Iași

  • Ovidius Clinical Hospital S.R.L.

    Ovidiu

Other trials in Romania

Argentina5 sites

  • Centro de Endocrinologia y Diabetes Dr. Raul A. Gutman SRL

    Buenos Aires

  • Fundacion Respirar

    Buenos Aires

  • Hospital Británico de Buenos Aires

    Buenos Aires

  • Sanatorio Parque - Rosario

    Rosario

  • Clinica Viedma

    Viedma

Other trials in Argentina

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment - Dobrich AD

    Dobrich

  • Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD

    Gabrovo

  • MHAT Uni Hospital OOD

    Panagyurishte

  • Complex Oncology Center Ruse

    Rousse

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia

Other trials in Bulgaria

Poland5 sites

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

    Gdynia

  • Przychodnia Lekarska "KOMED"

    Konin

  • Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi

    Lodz

  • IP Clinic Sp. z o.o.

    Lodz

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    Warsaw

Other trials in Poland

Croatia4 sites

  • Klinički Bolnički Centar Osijek

    Osijek

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

    Zagreb

  • Klinički Bolnički Centar Sestre Milosrdnice

    Zagreb

  • Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

    Zagreb

Other trials in Croatia

Georgia4 sites

  • High-tech Hospital Med Center

    Batumi

  • High Technology Medical Center, University Clinic

    Tbilisi

  • Institute of Clinical Oncology

    Tbilisi

  • Mardaleishvili Medical Centre

    Tbilisi

Other trials in Georgia

Ireland4 sites

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • Tallaght University Hospital

    Dublin

Other trials in Ireland

Malaysia4 sites

  • Hospital Tengku Ampuan Afzan

    Kuantan

  • Hospital Umum Sarawak - Clinical Research Centre

    Kuching

  • Gleneagles Medical Centre - Penang

    Pulau Pinang

  • Hospital Pulau Pinang

    Pulau Pinang

Other trials in Malaysia

United States3 sites

  • New Mexico Oncology Hematology Consultants, Ltd.

    Albuquerque, New Mexico, 87109

  • Ascension Seton Infusion Center

    Austin, Texas, 78712

  • Norton Cancer Institute - Audubon

    Louisville, Kentucky, 40217

Other trials in United States

Belgium3 sites

  • Antwerp University Hospital

    Antwerp

  • Algemeen Ziekenhuis Maria Middelares

    Ghent

  • Clinique et Maternité Sainte-Elisabeth

    Namur

Other trials in Belgium

Canada3 sites

  • Brampton Civic Hospital

    Brampton

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

    Montreal

  • Unite de recherche clinique du CISSS des Laurentides

    Saint-Jérôme

Other trials in Canada

Thailand3 sites

  • Phramongkutklao Hospital

    Bangkok

  • Faculty of Medicine Vajira Hospital

    Dusit

  • Prince of Songkhla University

    Hat Yai

Other trials in Thailand

United Kingdom3 sites

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

    Birmingham

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester

Other trials in United Kingdom

Austria2 sites

  • Landeskrankenhaus-Universitätsklinikum Graz, KLinische Abteilung für Pulmonologie

    Graz

  • Vienna General Hospital

    Vienna

Other trials in Austria

Chile2 sites

  • Centro de Oncologia de Precision

    Las Condes

  • Facultad Odontología Unipac

    Santiago

Other trials in Chile

Hungary2 sites

  • Debreceni Egyetem Klinikai Központ

    Debrecen

  • Tolna Vármegyei Balassa János Kórház

    Szekszárd

Other trials in Hungary

Latvia2 sites

  • Latvian Oncology Center

    Riga

  • Paula Stradiņa Klīniskā Universitātes Slimnīca

    Riga

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas

  • Nacionalinis Vezio Institutas

    Vilnius

Other trials in Lithuania

About this study

Official title: 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.

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.

Read the detailed description

TACTI-004 is a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (major histocompatibility complex (MHC) class II agonist) in combination with pembrolizumab (programmed cell death protein 1 (PD-1) antagonist) and chemotherapy.

The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (SoC, pembrolizumab and histology-based chemotherapy) compared to placebo combined with SoC in programmed death-ligand 1 (PD-L1) unselected population as assessed by:

  • Overall survival [OS]
  • Progression-free survival [PFS] per RECIST 1.1

The trial is planned to be conducted in countries in Asia, Australia, Europe and North and South America in approximately 175 experienced clinical sites.

Being tested
eftilagimod alfa, carboplatin plus paclitaxel, cisplatin or carboplatin + pemetrexed, pembrolizumab (KEYTRUDA®), Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eftilagimod alfaBiological

    Also called IMP321, LAG-3Ig, efti, eftilagimod alpha

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

  • carboplatin plus paclitaxelDrug

    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

  • cisplatin or carboplatin + pemetrexedDrug

    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

  • pembrolizumab (KEYTRUDA®)Biological

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

  • PlaceboOther

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

Study groups in NCT06726265
Study groupRoleWhat they receive
efti + Standard of Care armExperimentalCombination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Receives: Biological: eftilagimod alfa; Drug: carboplatin plus paclitaxel; Drug: cisplatin or carboplatin + pemetrexed; Biological: pembrolizumab (KEYTRUDA®)
Placebo + Standard of Care armPlacebo comparatorCombination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Receives: Drug: carboplatin plus paclitaxel; Drug: cisplatin or carboplatin + pemetrexed; Biological: pembrolizumab (KEYTRUDA®); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of Overall survival (OS)

    Measured: Up to approximately 54 months

  2. Determination of Progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Measured: Up to approximately 54 months

Secondary outcomes (6)

  1. Determination of Objective response rate (ORR) per RECIST 1.1

    Measured: Up to approximately 54 months

  2. Frequency of adverse events (AEs)

    Measured: Up to approximately 27 months

  3. Severity of adverse events (AEs) according to the United States National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0

    Measured: Up to approximately 27 months

  4. Determination of Time to Response (TTR) by RECIST 1.1.

    Measured: Up to approximately 54 months

  5. Determination of Duration of Response (DOR) by RECIST 1.1.

    Measured: Up to approximately 54 months

  6. Determination of PFS on next line therapy (PFS2)

    Measured: Up to approximately 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start21 Mar 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
756 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726265
Sponsor's protocol ID
TACTI-004
Other IDs
2024-513621-23-00, KEYNOTE-F91, MK-3475-F91, IMP321-P026
Status last verified
Nov 2025
First submitted
3 Dec 2024
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • O'Byrne K, Esteban E, Lee CL, Hegmane A, Volovat C, Lo Russo G, Ziogas D, Atmaca A, Sebastian M, Majem M. A phase III placebo-controlled study of eftilagimod alfa plus pembrolizumab and chemotherapy in metastatic non-small cell lung cancer. Future Oncol. 2025 Dec;21(30):3885-3890. doi: 10.1080/14796694.2025.2597404. Epub 2025 Dec 12.

    PubMed 41383151

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing eftilagimod alfa, carboplatin plus paclitaxel and cisplatin or carboplatin + pemetrexed in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Immutep S.A.S. at 147 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in Spain, Germany, Turkey (Türkiye), India, Australia and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of Overall survival (OS) (time frame: Up to approximately 54 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06726265, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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