Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo aims to extend life in advanced lung cancer

NCT ID NCT06726265

Disease control Sponsor: Immutep S.A.S. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding eftilagimod alfa to standard immunotherapy (pembrolizumab) and chemotherapy helps people with advanced non-small cell lung cancer live longer or keep their cancer from growing. About 756 adults who have not had prior treatment for their advanced disease will receive either the new combination or a placebo plus standard care. The study is active but no longer recruiting new participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 756 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Participants may be enrolled if they meet all of the following criteria at screening: 1. Willing to give written informed consent and to comply with the protocol. 2. 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. 3. 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. 4. 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). 5. Be ≥ 18 years of age on the day of signing the informed consent. 6. 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. 7. 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. 8. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization. 9. Expected survival \> 3 months. 10. Evidence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by site. 11. 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. 12. 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. 13. 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. 14. 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. 15. Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease. 16. Adequate organ function. Exclusion Criteria Participants are to be excluded from the trial at the time of screening for any of the following reasons: 1. 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). 2. Received prior radiotherapy within 2 weeks of start of trial intervention, or has radiation-related toxicities, requiring corticosteroids. 3. Participants whose tumor harbors any of the following actionable molecular alterations: 1. Epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation 2. Anaplastic lymphoma kinase (ALK) gene fusion positive (ALK translocation) 3. c-ROS oncogene 1 (ROS1) translocation 4. For any indication has received any of the following therapies 1. 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; 2. 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; 3. within 6 months prior to cycle1 day 1 received lung radiation therapy of \>30 Gray (Gy). 5. 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. 6. 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. 7. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 8. 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. 9. 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. 10. 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. 11. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 12. 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. 13. 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. 14. 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. 15. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. 16. History of allogenic tissue/solid organ transplant. 17. Known additional malignancy that is progressing or has required active treatment within the past 3 years. 18. Has hypersensitivity to eftilagimod alfa and/or pembrolizumab (≥Grade 3) and/or any of its excipients. 19. Has hypersensitivity to any component of planned platinum-based doublet chemotherapy and/or any of its excipients. 20. Received a live or live-attenuated vaccine within 30 days before the first dose of trial intervention. Administration of killed vaccines is allowed 21. Has a life-threatening illness unrelated to cancer. 22. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced/metastatic non-small cell lung cancer (NSCLC) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced/metastatic non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • Adana Medical Park Seyhan Hospital

    Adana, Turkey (Türkiye)

  • Adana Sehir Training and Research Hospital

    Adana, Turkey (Türkiye)

  • Agaplesion Medizinisches Versorgungszentrum - Frankfurt gGmbH

    Frankfurt, Germany

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Belgium

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

    Bhubaneswar, India

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    Ankara, Turkey (Türkiye)

  • Antwerp University Hospital

    Antwerp, Belgium

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Italy

  • Ascension Seton Infusion Center

    Austin, Texas, 78712, United States

  • Asklepios Fachkliniken München-Gauting

    Gauting, Germany

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Italy

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, Italy

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della Misericordia

    Perugia, Italy

  • Bahcelievler Memorial Hospital

    Istanbul, Turkey (Türkiye)

  • Beaumont Hospital

    Dublin, Ireland

  • Bioclinic of Thessaloniki

    Thessaloniki, Greece

  • Brampton Civic Hospital

    Brampton, Canada

  • Calvary Mater Newcastle

    Waratah, Australia

  • Cancer Care Wollongong Pty Limited

    Wollongong, Australia

  • Centro Integrado de Oncologia de Curitiba - CIONC

    Curitiba, Brazil

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

    Buenos Aires, Argentina

  • Centro de Oncologia de Precision

    Las Condes, Chile

  • Centro di Riferimento Oncologico (CRO)

    Aviano, Italy

  • Centrul Medical Medicover Victoria

    Bucharest, Romania

  • Cetus Oncologia Hospital Dia - Belo Horizonte

    Horizonte, Brazil

  • Chittaranjan National Cancer Institute

    Kolkata, India

  • Clinica Viedma

    Viedma, Argentina

  • Clinique et Maternité Sainte-Elisabeth

    Namur, Belgium

  • Complex Oncology Center Ruse

    Rousse, Bulgaria

  • Cork University Hospital

    Cork, Ireland

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hungary

  • Evangelische Lungenklinik Berlin

    Berlin, Germany

  • Facharztzentrum Eppendorf

    Hamburg, Germany

  • Facultad Odontología Unipac

    Santiago, Chile

  • Faculty of Medicine Vajira Hospital

    Dusit, Thailand

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Fundacion Respirar

    Buenos Aires, Argentina

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, Germany

  • General Hospital of Athens "Laiko"

    Athens, Greece

  • Geri Care Hospital T.Nagar

    Chennai, India

  • Gleneagles Medical Centre - Penang

    Pulau Pinang, Malaysia

  • Greenslopes Private Hospital

    Greenslopes, Australia

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, Turkey (Türkiye)

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

    Bangalore, India

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, Germany

  • HM Universitario Sanchinarro

    Madrid, Spain

  • Hacettepe Universitesi Kanser Enstitusu (Hacettepe University Cancer Institute)

    Ankara, Turkey (Türkiye)

  • High Technology Medical Center, University Clinic

    Tbilisi, Georgia

  • High-tech Hospital Med Center

    Batumi, Georgia

  • Hospital Beneficencia Portuguesa - Mirante

    São Paulo, Brazil

  • Hospital Británico de Buenos Aires

    Buenos Aires, Argentina

  • Hospital CUF Descobertas

    Lisbon, Portugal

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Clínico Universitario "Lozano Blesa"

    Zaragoza, Spain

  • Hospital Garcia de Orta, EPE

    Almada, Portugal

  • Hospital Lusíadas Lisboa

    Lisbon, Portugal

  • Hospital Nossa Senhora da Conceicao (HNSC)

    Porto Alegre, Brazil

  • Hospital Pulau Pinang

    Pulau Pinang, Malaysia

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, Spain

  • Hospital Santa Rita - Vitoria

    Vitória, Brazil

  • Hospital Tengku Ampuan Afzan

    Kuantan, Malaysia

  • Hospital Umum Sarawak - Clinical Research Centre

    Kuching, Malaysia

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, Lithuania

  • IP Clinic Sp. z o.o.

    Lodz, Poland

  • Institute of Clinical Oncology

    Tbilisi, Georgia

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

    Barcelona, Spain

  • Instituto Português Oncologia do Porto Francisco Gentil, EPE

    Porto, Portugal

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

    Lodz, Poland

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, Greece

  • Istanbul Oncology Hospital

    Cevizli, Turkey (Türkiye)

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

    Naples, Italy

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

    Candiolo, Italy

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

    Zagreb, Croatia

  • Klinikum Augsburg

    Augsburg, Germany

  • Klinikum St. Marien

    Amberg, Germany

  • Klinički Bolnički Centar Osijek

    Osijek, Croatia

  • Klinički Bolnički Centar Sestre Milosrdnice

    Zagreb, Croatia

  • Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

    Zagreb, Croatia

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, Germany

  • Krankenhaus Nordwest

    Frankfurt am Main, Germany

  • Landeskrankenhaus-Universitätsklinikum Graz, KLinische Abteilung für Pulmonologie

    Graz, Austria

  • Latvian Oncology Center

    Riga, Latvia

  • Lyell McEwin Hospital

    Elizabeth Vale, Australia

  • MHAT Uni Hospital OOD

    Panagyurishte, Bulgaria

  • Mardaleishvili Medical Centre

    Tbilisi, Georgia

  • Mater Misericordiae University Hospital

    Dublin, Ireland

  • Maulana Azad Medical College

    New Delhi, India

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

    Montreal, Canada

  • Metropolitan Hospital, Department of Oncology

    Piraeus, Greece

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

    Gabrovo, Bulgaria

  • Multiprofile Hospital for Active Treatment - Dobrich AD

    Dobrich, Bulgaria

  • Multiprofile Hospital for Active Treatment Serdika EOOD

    Sofia, Bulgaria

  • Nacionalinis Vezio Institutas

    Vilnius, Lithuania

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    Warsaw, Poland

  • New Mexico Oncology Hematology Consultants, Ltd.

    Albuquerque, New Mexico, 87109, United States

  • Norton Cancer Institute - Audubon

    Louisville, Kentucky, 40217, United States

  • Onco Clinic Consult SA

    Craiova, Romania

  • OncoLab

    Craiova, Romania

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Brazil

  • Ovidius Clinical Hospital S.R.L.

    Ovidiu, Romania

  • Parc Tauli Hospital Universitari

    Sabadell, Spain

  • Paula Stradiņa Klīniskā Universitātes Slimnīca

    Riga, Latvia

  • Phramongkutklao Hospital

    Bangkok, Thailand

  • Prince of Songkhla University

    Hat Yai, Thailand

  • Przychodnia Lekarska "KOMED"

    Konin, Poland

  • Regional Cancer Centre Thiruvananthapuram

    Thiruvananthapuram, India

  • Robert-Bosch-Krankenhaus

    Stuttgart, Germany

  • Royal Darwin Hospital

    Tiwi, Australia

  • Sakarya Universitesi Tıp Fakultesi Dekanligi

    Sakarya, Turkey (Türkiye)

  • Sanatorio Parque - Rosario

    Rosario, Argentina

  • Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Brazil

  • Sotiria Chest Diseases Hospital

    Athens, Greece

  • Spitalul Memorial Healthcare International

    Bucharest, Romania

  • St John of God Subiaco Hospital

    Subiaco, Australia

  • St. Luke's Hospital S.A.

    Thessaloniki, Greece

  • Sunact Cancer Institute Pvt. Ltd.

    Thane, India

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

    Gdynia, Poland

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

    Istanbul, Turkey (Türkiye)

  • Tallaght University Hospital

    Dublin, Ireland

  • Tasman Oncology Research Ltd

    Southport, Australia

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

    Varanasi, India

  • The Alfred Hospital

    Melbourne, Australia

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester, United Kingdom

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford, United Kingdom

  • Tolna Vármegyei Balassa János Kórház

    Szekszárd, Hungary

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Hastane

    Edirne, Turkey (Türkiye)

  • Uludağ Üniversitesi Tıp Fakültesi

    Bursa, Turkey (Türkiye)

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

    Loures, Portugal

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

    Lisbon, Portugal

  • Unite de recherche clinique du CISSS des Laurentides

    Saint-Jérôme, Canada

  • Universidade de Caxias do Sul

    Caxias do Sul, Brazil

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

    Birmingham, United Kingdom

  • University of Patras - Rio Regional University Hospital

    Pátrai, Greece

  • University of Thessaly- General University Hospital of Larissa

    Larissa, Greece

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Köln

    Cologne, Germany

  • Victoria Hospital - Centrul de Oncologie Euroclinic SRL

    Iași, Romania

  • Vienna General Hospital

    Vienna, Austria

  • Voluntary Health Services Hospital

    Chennai, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.