Clinical trial • Phase III • Oncology

EFTILAGIMOD ALFA for Non-small cell lung cancer (advanced/metastatic)

Phase III trial of EFTILAGIMOD ALFA for Non-small cell lung cancer (advanced/metastatic).

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Non-small cell lung cancer (advanced/metastatic)
Trial Stage: Phase III
Drug Modality: Peptide/protein/enzyme|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date: 11-11-2024
First CTIS Authorization Date: 07-03-2025

Trial design

Randomised, two arms: e+soc arm (eftilagimod alfa + pembrolizumab + histology-based platinum doublet chemotherapy) versus placebo+soc arm (efti-matching placebo + pembrolizumab + histology-based platinum doublet chemotherapy). specific dosing/schedule details are not fully specified in the ctis public data.-controlled, adaptive Phase III trial in Greece, Latvia, Portugal and others.

Randomised: Yes
Comparator: Two arms: E+SoC arm (eftilagimod alfa + pembrolizumab + histology-based platinum doublet chemotherapy) versus Placebo+SoC arm (efti-matching placebo + pembrolizumab + histology-based platinum doublet chemotherapy). Specific dosing/schedule details are not fully specified in the CTIS public data.
Adaptive: True, interim analyses and stopping rules applied: an Independent Data Monitoring Committee (IDMC) performed an interim futility analysis (futility boundary) which led to recommendation to terminate the trial; executive data review committee (EDRC) confirmed results and sponsor implemented urgent safety measures to halt enrollment and dosing.
Target Sample Size: 393
Trial Duration For Participant: 1465

Eligibility

Recruits 393 Participants must be ≥18 and provide written informed consent. Specific vulnerable-population considerations in the protocol include requirements for participants of childbearing potential (pregnancy testing, contraception and breastfeeding restrictions), and guidance for inclusion of persons with controlled HIV, HBV or HCV (specific virologic control and treatment stability requirements). Study information and informed consent forms are provided in multiple local languages (see trial documents) and investigators are instructed to obtain written informed consent prior to any trial procedures; no enrolment of minors is permitted..

Pregnancy Exclusion: A participant of childbearing potential (POCBP) is eligible to participate if not pregnant and a negative pregnancy test before the first dose of trial intervention has been obtained. Additional requirements for pregnancy testing during and after trial intervention are in Contraception Methods. - A POCBP is eligible to participate if not breastfeeding during the trial intervention period and as defined in the protocol. - A POCBP is eligible to participate if a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency is used, or penile-vaginal intercourse abstinence, as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), is adhered to as described in Protocol Section 5.13 during the intervention period and for at least the time needed to eliminate each trial intervention after the last dose of trial intervention. In addition, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction. The length of time required to continue contraception for each trial intervention is defined in the protocol.
Vulnerable Population: Participants must be ≥18 and provide written informed consent. Specific vulnerable-population considerations in the protocol include requirements for participants of childbearing potential (pregnancy testing, contraception and breastfeeding restrictions), and guidance for inclusion of persons with controlled HIV, HBV or HCV (specific virologic control and treatment stability requirements). Study information and informed consent forms are provided in multiple local languages (see trial documents) and investigators are instructed to obtain written informed consent prior to any trial procedures; no enrolment of minors is permitted.

Inclusion criteria

{"criterion_text":"- Willing to give written informed consent and to comply with the protocol.\n- Evidence of measurable disease as defined by RECIST 1.1 as determined by site.\n- 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.\n- 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.\n- 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.\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization.\n- Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as: a. Participants on ART must have a CD4+ T-cell count > 350 cells/mm3 at time of screening. b. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening. c. Participants on ART must have been on stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to cycle 1 day 1. d. It is advised that participants must not have had any acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months. e. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates.\n- Adequate organ function as defined in the protocol. Specimens must be collected within 10 days before randomization.\n- Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) 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 (previous palliative radiotherapy for advanced/metastatic disease acceptable).\n- 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.\n- Availability of PD-L1 biomarker result from central laboratory, using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).\n- Be ≥ 18 years of age on the day of signing the informed consent.\n- If assigned male at birth, the participant agrees to the following during the intervention period and for at least the time needed to eliminate the following interventions after the last dose of the specified trial intervention. The length of time required to continue contraception for trial interventions is: • cisplatin: 100 days • carboplatin: 100 days • pemetrexed: 100 days • paclitaxel: 100 days - Refrains from donating sperm PLUS either: - Abstains from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR - Uses a penile/external condom when having intercourse PLUS partner of childbearing potential who is not currently pregnant should use an additional contraceptive method (refer to Protocol Section 5.13), as a condom may break or leak. - Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. If the contraception requirements in the local label for any of the trial interventions are more stringent than the requirements above, the local label requirements are to be followed.\n- A participant of childbearing potential (POCBP) is eligible to participate if not pregnant and a negative pregnancy test before the first dose of trial intervention has been obtained. Additional requirements for pregnancy testing during and after trial intervention are in Contraception Methods. - A POCBP is eligible to participate if not breastfeeding during the trial intervention period and as defined in the protocol. - A POCBP is eligible to participate if a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency is used, or penile-vaginal intercourse abstinence, as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), is adhered to as described in Protocol Section 5.13 during the intervention period and for at least the time needed to eliminate each trial intervention after the last dose of trial intervention. In addition, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction. The length of time required to continue contraception for each trial intervention is defined in the protocol.\n- An ECOG performance status of 0 to 1 assessed within 7 days before randomization.\n- Expected survival > 3 months."}

Exclusion criteria

{"criterion_text":"- 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).\n- 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 (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.\n- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n- 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.\n- 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.\n- 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.\n- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.\n- History of allogenic tissue/solid organ transplant.\n- Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n- Has hypersensitivity to eftilagimod alfa and/or pembrolizumab (≥Grade 3) and/or any of its excipients.\n- Has hypersensitivity to any component of planned platinum-based doublet chemotherapy and/or any of its excipients.\n- Received prior radiotherapy within 2 weeks of start of trial intervention, or has radiation-related toxicities, requiring corticosteroids.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of trial intervention. Administration of killed vaccines is allowed. Refer to Protocol Section 5.10 for information on COVID-19 vaccines.\n- Has a life-threatening illness unrelated to cancer.\n- 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.\n- Participants whose tumor harbors any of the following actionable molecular alterations: a. epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation; b. anaplastic lymphoma kinase (ALK) gene fusion positive (ALK translocation); c. c-ROS oncogene 1 (ROS1) translocation.\n- For any indication has received any of the following therapies: a. 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; b. 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; c. within 6 months prior to cycle 1 day 1 received lung radiation therapy of >30 Gray (Gy).\n- 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.\n- 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., CTLA-4, OX 40, CD137) or lymphocyte activation gene 3 (LAG-3) targeting therapy (e.g., anti-LAG-3 antibodies). Note: 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.\n- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.\n- 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. Note: Participants with available neuroimaging performed as routine clinical management before the Screening imaging may be enrolled using this exception and compared to the imaging conducted at Screening.\n- 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."}

Endpoints

Primary endpoints

{"endpoint_text":"- Overall survival (OS) is defined as the time from randomization to death from any cause.","definition_or_measurement_approach":"OS: time from randomization to death from any cause; measured by investigator/site records and survival status."}
{"endpoint_text":"- PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), defined as the time from randomization to documented disease progression or death from any cause as assessed by the Investigator assessment based on RECIST.","definition_or_measurement_approach":"PFS: assessed per RECIST 1.1 by Investigator assessment; time from randomization to documented disease progression or death from any cause."}

Secondary endpoints

{"endpoint_text":"- ORR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have best overall confirmed response (BOR) of complete response (CR) or partial response (PR).","definition_or_measurement_approach":"ORR: proportion with confirmed CR or PR per RECIST 1.1 by Investigator."}
{"endpoint_text":"- Frequency, severity, and duration of adverse events (AEs), and clinically relevant abnormalities in vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and safety laboratory assessments.","definition_or_measurement_approach":"Safety: captured per NCI CTCAE v5.0, routine vital signs, physical exams, 12-lead ECGs and labs."}
{"endpoint_text":"- DCR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have BOR of confirmed CR or confirmed PR or stable disease (SD) (for ≥ 6 weeks).","definition_or_measurement_approach":"DCR: proportion with confirmed CR, PR or SD (≥6 weeks) per RECIST 1.1 by Investigator."}
{"endpoint_text":"- DOR is defined as the time from the date a response of confirmed CR or confirmed PR was first documented until the date of the first documentation of disease progression.","definition_or_measurement_approach":"DOR: time from first confirmed CR/PR to first documentation of progression."}
{"endpoint_text":"- TTR is defined as the time from the date of first treatment to the date of the first documented confirmed CR or confirmed PR.","definition_or_measurement_approach":"TTR: time from first treatment to first documented confirmed CR or PR."}
{"endpoint_text":"- TTNT defined from the date of randomization to the date of any post-trial procedure or therapy for the same disease.","definition_or_measurement_approach":"TTNT: time from randomization to start of any next-line treatment or procedure for same disease."}
{"endpoint_text":"- Changes from baseline in QoL as assessed by European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30); EORTC QLQ-LC13 and EuroQol 5 Dimension 5 Level (EQ-5D-5L).","definition_or_measurement_approach":"QoL: changes from baseline on EORTC QLQ-C30, QLQ-LC13 and EQ-5D-5L at scheduled timepoints."}
{"endpoint_text":"- PFS2 defined as the time from randomization to disease progression or death from any cause (whichever occurs first) on next-line treatment.","definition_or_measurement_approach":"PFS2: time from randomization to progression or death on next-line therapy."}

Recruitment

Registry Or Advocacy Recruitment: True - Advocacy outreach materials are provided (specific registry or advocacy group names are not specified in the publicly available documents).
Digital Remote Recruitment: True - Digital/remote elements are indicated by use of electronic study materials and eCOA/electronic systems (vendors such as Clario and Veeva are listed in sponsor third-parties) and a device specification document (Lenovo K10 Spec Sheet) is included among recruitment materials.
Planned Sample Size: 393
Recruitment Window Months: 52
Consent Approach: Written informed consent is required from each participant prior to any study procedures. Participants must be ≥18 and provide written informed consent. Informed consent and subject information sheets are provided in multiple local languages (documents include redacted L1 SIS and ICFs in various languages such as English, Russian, Latvian, Lithuanian, Bulgarian, Greek, Spanish, Italian, Portuguese, Hungarian, etc.). Consent includes specific information and requirements for childbearing potential participants (pregnancy testing, contraception), and separate information/consent materials are provided for pregnancy/partner follow-up where applicable.

Methods

Site-based recruitment via participating hospitals/oncology clinics (site lists and contact persons provided in Part II approvals).
Printed recruitment materials: brochures and flyers (country-specific versions and translations available).
Advocacy outreach: 'Advocacy Outreach' recruitment materials prepared to engage patient advocacy channels.
Patient-facing study overview materials and patient ID cards provided to sites and patients.
Translated recruitment/information materials and ICFs: study materials provided in multiple local languages for country-specific recruitment.

Geography

Total Number Of Sites: 96
Total Number Of Participants: 363

Greece

Earliest CTIS Part Ii Submission Date: 04-12-2024
Latest Decision Or Authorization Date: 10-03-2025
Processing Time Days: 96
Number Of Sites: 8
Number Of Participants: 29

Sites

Site Name: General University Hospital Of Patras
Department Name: Oncology Department
Contact Person Name: Angelos Koutras
Contact Person Email: angkoutr@otenet.gr

Site Name: Athens Medical Center S.A.
Department Name: Oncology Department
Contact Person Name: Ippokratis Korantzis
Contact Person Email: ippokratis.korantzis@gmail.com

Site Name: General University Hospital Of Larissa
Department Name: Department of Medical Oncology
Contact Person Name: Athanasios Kotsakis
Contact Person Email: kotsakisthan@gmail.com

Site Name: Thoracic General Hospital Of Athens I Sotiria
Department Name: 3rd Department of Internal Medicine
Contact Person Name: Konstantinos Syrigos
Contact Person Email: gpp.trials@gmail.com

Site Name: Bioclinic S.A.
Department Name: Oncology Department
Contact Person Name: Ioannis Boukovinas
Contact Person Email: ibouk@otenet.gr

Site Name: St. Luke's Hospital S.A.
Department Name: Deapartment of Medical Oncology
Contact Person Name: Eleni Fountzila
Contact Person Email: elenafou@gmail.com

Site Name: Laiko General Hospital Of Athens
Department Name: 1st Department of Internal Medicine Oncology Department
Contact Person Name: Helen Gogas
Contact Person Email: helgogas@gmail.com

Site Name: Metropolitan Hospital
Department Name: 1st Department of Oncology
Contact Person Name: Dimitrios Bafaloukos
Contact Person Email: dimmp@otenet.gr

Latvia

Earliest CTIS Part Ii Submission Date: 20-02-2025
Latest Decision Or Authorization Date: 20-03-2025
Processing Time Days: 28
Number Of Sites: 2
Number Of Participants: 13

Sites

Site Name: Pauls Stradins Clinical University Hospital
Department Name: Clinic of oncology
Contact Person Name: Aija Gerina
Contact Person Email: aija.gerina@stradini.lv

Site Name: Rigas Austrumu kliniska universitates slimnica SIA
Department Name: Oncology center
Contact Person Name: Alinta Hegmane
Contact Person Email: alinta.hegmane@aslimnica.lv

Portugal

Earliest CTIS Part Ii Submission Date: 14-02-2025
Latest Decision Or Authorization Date: 07-03-2025
Processing Time Days: 21
Number Of Sites: 6
Number Of Participants: 15

Sites

Site Name: Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name: Oncologia Médica
Contact Person Name: Cristina Oliveira
Contact Person Email: croliveira@ipoporto.min-saude.pt

Site Name: Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name: Pulmonology
Contact Person Name: Miguel Lopes
Contact Person Email: jmglps@gmail.com

Site Name: Lusiadas S.A.
Department Name: Oncology
Contact Person Name: Ricardo Luz
Contact Person Email: ricardo.martins.luz@lusiadas.pt

Site Name: Hospital Cuf Descobertas S.A.
Department Name: Oncology
Contact Person Name: Li Bei
Contact Person Email: li.bei@cuf.pt

Site Name: Unidade Local De Saude De Loures-Odivelas EPE
Department Name: Oncology
Contact Person Name: Diana Neto Da Silva
Contact Person Email: diana.neto.silva@ulslod.min-saude.pt

Site Name: Unidade Local De Saude De Santa Maria E.P.E.
Department Name: Hospital de dia Pneumologia Oncológica
Contact Person Name: Direndra Hasmucrai
Contact Person Email: direndrahasmucrai@gmail.com

Romania

Earliest CTIS Part Ii Submission Date: 18-02-2025
Latest Decision Or Authorization Date: 24-03-2025
Processing Time Days: 34
Number Of Sites: 6
Number Of Participants: 36

Sites

Site Name: Oncolab S.R.L.
Department Name: Oncology
Contact Person Name: Cristian-Virgil Lungulescu
Contact Person Email: cristilungulescu@yahoo.com

Site Name: Centrul De Oncologie-Euroclinic S.R.L.
Department Name: Oncology
Contact Person Name: Constantin Volovat
Contact Person Email: cvolovat@gmail.com

Site Name: Medicover S.R.L.
Department Name: Oncology
Contact Person Name: Radu Emanuel Berceanu-Ion
Contact Person Email: office@medicover.com

Site Name: Memorial Healthcare International S.R.L.
Department Name: Oncology
Contact Person Name: Ingrid Adriana Iordan
Contact Person Email: ingrid.iordan@memorial.ro

Site Name: Onco Clinic Consult S.A.
Department Name: Oncology
Contact Person Name: Patricia Visan
Contact Person Email: p.visan@oncoclinic.ro

Site Name: Ovidius Clinical Hospital S.R.L.
Department Name: Oncology
Contact Person Name: Laura Mazilu
Contact Person Email: lauragrigorov@gmail.com

Italy

Earliest CTIS Part Ii Submission Date: 04-12-2024
Latest Decision Or Authorization Date: 25-03-2025
Processing Time Days: 111
Number Of Sites: 11
Number Of Participants: 36

Sites

Site Name: Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name: Medical Oncology 1
Contact Person Name: Giuseppe Lo Russo
Contact Person Email: Giuseppe.LoRusso@istitutotumori.mi.it

Site Name: Azienda Ospedaliera Di Perugia
Department Name: S.C. Oncologia medica
Contact Person Name: Giulio Metro
Contact Person Email: giulio.metro@ospedale.perugia.it

Site Name: Azienda Ospedaliera S Maria Di Terni
Department Name: S.C. ONCOLOGIA
Contact Person Name: Cristina Zannori
Contact Person Email: c.zannori@aospterni.it

Site Name: AORN San Giuseppe Moscati Avellino
Department Name: UO Oncologia Medica
Contact Person Name: Cesare Gridelli
Contact Person Email: cgridelli@libero.it

Site Name: IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name: Thoracopulmonary Department
Contact Person Name: Alessandro Morabito
Contact Person Email: a.morabito@istitutotumori.na.it

Site Name: Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name: S.C. Oncologia medica
Contact Person Name: Vanesa Gregorc
Contact Person Email: vanesa.gregorc@ircc.it

Site Name: Azienda Socio Sanitaria Territoriale Ovest Milanese
Department Name: S.C. Oncologia medica
Contact Person Name: Andrea Luciani
Contact Person Email: Andrea.luciani@asst-ovestmi.it

Site Name: Centro Di Riferimento Oncologico Di Aviano
Department Name: Oncologia medica e dei tumori immuno-correlati
Contact Person Name: Alessandra Bearz
Contact Person Email: abearz@cro.it

Site Name: Azienda USL IRCCS Di Reggio Emilia
Department Name: S.C. Oncologia medica
Contact Person Name: Maria Pagano
Contact Person Email: Maria.Pagano@ausl.re.it

Site Name: Istituto Nazionale Tumori (other listed sites)
Department Name: Various oncology departments

Site Name: Other Italian participating site

Croatia

Earliest CTIS Part Ii Submission Date: 21-02-2025
Latest Decision Or Authorization Date: 24-03-2025
Processing Time Days: 31
Number Of Sites: 4
Number Of Participants: 18

Sites

Site Name: Klinicki Bolnicki Centar Osijek
Department Name: Oncology department
Contact Person Name: Ivana Canjko
Contact Person Email: Ivana.canjko@kbco.hr

Site Name: Klinicki bolnicki centar Sestre milosrdnice (Ilica 197)
Department Name: Department of Medical Oncology
Contact Person Name: Ljubica Vazdar
Contact Person Email: ljubica.vazdar@kbcsm.hr

Site Name: Klinicki bolnicki centar Sestre milosrdnice (Vinogradska Cesta 29)
Department Name: Clinic for Oncology and Nuclear Medicine
Contact Person Name: Jasmina Marić-Brozić
Contact Person Email: jasmina.maric.brozic@kbcsm.hr

Site Name: KBC Zagreb
Department Name: Clinic for Pulmonary Diseases, Department of Lung and Mediastinal Tumors
Contact Person Name: Miroslav Samaržija
Contact Person Email: miroslav.samarzija@kbc-zagreb.hr

Germany

Earliest CTIS Part Ii Submission Date: 17-02-2025
Latest Decision Or Authorization Date: 10-03-2025
Processing Time Days: 21
Number Of Sites: 16
Number Of Participants: 52

Sites

Site Name: Goethe University Frankfurt
Department Name: Medizinische Klinik II
Contact Person Name: Martin Sebastian
Contact Person Email: sebastian@med.uni-frankfurt.de

Site Name: Medical Center - University Of Freiburg
Department Name: Klinik für Innere Medizin I – Hämotologie, Onkologie und Stammzelltransplantation
Contact Person Name: Cornelius Waller
Contact Person Email: cornelius.waller@uniklinik-freiburg.de

Site Name: Robert Bosch Krankenhaus GmbH
Department Name: Hämatologie, Onkologie und Palliativmedizin
Contact Person Name: Hans-Georg Kopp
Contact Person Email: hans-georg.kopp@rbk.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Medizinische Klinik III - Pneumologie
Contact Person Name: Sabine Bohnet
Contact Person Email: studienzentrum.pneumologie-infektiologie@uksh.de

Site Name: Krankenhaus Nordwest GmbH
Department Name: Institute of Clinical Cancer Research (IKF)
Contact Person Name: Thorsten Goetze
Contact Person Email: goetze.thorsten@khnw.de

Site Name: Asklepios Klinik Gauting GmbH
Department Name: Zentrum für Pneumologie und Thoraxchirurgie; Thorakale Onkologie
Contact Person Name: Niels Reinmuth
Contact Person Email: n.reinmuth@asklepios.com

Site Name: Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name: Center for Pneumology and Thorac Sugery, Department of Pneumology
Contact Person Name: Karsten Schulmann
Contact Person Email: karsten.schulmann@lkhemer.de

Site Name: Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name: Klinik für Pneumologie
Contact Person Name: Christian Grohé
Contact Person Email: christian.grohe@jsd.de

Site Name: Klinikum St Marien Amberg
Department Name: Studienzentrum
Contact Person Name: Ludwig Fischer von Weikersthal
Contact Person Email: weikersthal.ludwig@klinikum-amberg.de

Site Name: Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name: Medical Clinic 1
Contact Person Name: Silvan Becker
Contact Person Email: silvan.becker@agaplesion.de

Site Name: Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name: Clinic for Internal Medicine II
Contact Person Name: Miriam Möller
Contact Person Email: miriam.moeller@martha-maria.de

Site Name: Universitaetsklinikum Augsburg
Department Name: II Deparment of internal medicine, Hematology/ Oncology
Contact Person Name: Bjoern Hackanson
Contact Person Email: bjoern.hackanson@uk-augsburg.de

Site Name: University Hospital Cologne AöR
Department Name: Klinik I für Innere Meidzin/LCGC
Contact Person Name: Richard Riedel
Contact Person Email: richard.riedel@uk-koeln.de

Site Name: Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
Contact Person Name: Janna-Lisa Velthaus-Rusik
Contact Person Email: velthaus@hope-hamburg.de

Site Name: HELIOS Klinikum Bad Saarow GmbH
Department Name: Klinik für Onkologie und Palliativmedizin
Contact Person Name: Daniel Pink
Contact Person Email: daniel.pink@helios-gesundheit.de

Site Name: Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie (GEHO)
Department Name: n.a.
Contact Person Name: Rüdiger Liersch
Contact Person Email: liersch@onkologie-muenster.de

Poland

Earliest CTIS Part Ii Submission Date: 07-02-2025
Latest Decision Or Authorization Date: 24-03-2025
Processing Time Days: 45
Number Of Sites: 7
Number Of Participants: 26

Sites

Site Name: Przychodnia Lekarska "KOMED" Roman Karaszewski
Contact Person Name: Bogusława Karaszewska
Contact Person Email: komed.badania@gmail.com

Site Name: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name: Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name: Sylwia Tabor
Contact Person Email: sylwia.tabor@nio.gov.pl

Site Name: Instytut Msf Sp. z o.o.
Contact Person Name: Ewa Kalinka
Contact Person Email: ewakalinka@wp.pl

Site Name: Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name: Oddział Dzienny Chemioterapii
Contact Person Name: Mariusz Kwiatkowski
Contact Person Email: mariusz.kwiatkowski@swk.med.pl

Site Name: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie (Gliwice)
Department Name: II Klinika Radioterapii i Chemioterapii
Contact Person Name: Barbara Ziółkowska
Contact Person Email: barbara.ziolkowska@gliwice.nio.gov.pl

Site Name: Ip Clinic Sp. z o.o.
Contact Person Name: Małgorzata Ułańska
Contact Person Email: malgorzata.ulanska@ipclinic.pl

Site Name: Szpitale Pomorskie Sp. z o.o.
Department Name: Oddział Onkologii Klinicznej
Contact Person Name: Iwona Danielewicz
Contact Person Email: idanielewicz@szpitalepomorskie.eu

Austria

Earliest CTIS Part Ii Submission Date: 21-02-2025
Latest Decision Or Authorization Date: 21-03-2025
Processing Time Days: 28
Number Of Sites: 2
Number Of Participants: 16

Sites

Site Name: Medical University Of Graz
Department Name: Klinische Abteilung für Pulmonologie
Contact Person Name: Robert Wurm
Contact Person Email: robert.wurm@uniklinikum.kages.at

Site Name: Medical University Of Vienna
Department Name: Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onkologie
Contact Person Name: Thorsten Füreder
Contact Person Email: thorsten.fuereder@meduniwien.ac.at

Spain

Earliest CTIS Part Ii Submission Date: 17-02-2025
Latest Decision Or Authorization Date: 07-03-2025
Processing Time Days: 18
Number Of Sites: 16
Number Of Participants: 48

Sites

Site Name: Instituto Oncologico Dr. Rosell S.L.
Department Name: Oncology
Contact Person Name: Roxana Reyes
Contact Person Email: rreyes@oncorosell.com

Site Name: Hospital Universitario Regional De Malaga
Department Name: Oncology
Contact Person Name: Manuel Cobo Dols
Contact Person Email: manuelcobodols@yahoo.es

Site Name: Institut Catala D'oncologia
Department Name: Oncology
Contact Person Name: Enric Carcereny Costa
Contact Person Email: ecarcereny@iconcologia.net

Site Name: Hospital De La Santa Creu I Sant Pau
Department Name: Oncology
Contact Person Name: Margarita Majem Tarruella
Contact Person Email: mmajem@santpau.cat

Site Name: Hospital Universitario Central De Asturias
Department Name: Oncology
Contact Person Name: Emilio Esteban Gonzalez
Contact Person Email: eestebang@seom.org

Site Name: Parc Tauli Hospital Universitari
Department Name: Oncology
Contact Person Name: Laia Vila Martinez
Contact Person Email: lvila@tauli.cat

Site Name: Hospital Universitario Hm Sanchinarro
Department Name: Oncology
Contact Person Name: Gema Garcia Ledo
Contact Person Email: gmgarcialedo@hmhospitales.com

Site Name: Hospital Universitario Fundacion Jimenez Diaz
Department Name: Oncology
Contact Person Name: Manuel Dómine Gómez
Contact Person Email: mdomine@fjd.es

Site Name: Hospital Universitario Ramon Y Cajal
Department Name: Oncology
Contact Person Name: Pilar Garrido Lopez
Contact Person Email: pgarrido.hrc@salud.madrid.org

Site Name: Hospital Universitario Reina Sofia
Department Name: Oncology
Contact Person Name: Isidoro Carlos Barneto Aranda
Contact Person Email: isidoroc.barneto.sspa@juntadeandalucia.es

Site Name: Hospital Universitari Vall D Hebron
Department Name: Oncology
Contact Person Name: Enriqueta Felip Font
Contact Person Email: efelip@vhio.net

Site Name: Hospital Clinico Universitario Lozano Blesa
Department Name: Oncology
Contact Person Name: Maria Dolores Isla Casado
Contact Person Email: lola.isla@gmail.com

Site Name: Hospital Universitario Virgen De La Macarena
Department Name: Oncology
Contact Person Name: Teresa Garcia Manrique
Contact Person Email: tgarciamanrique.onco@gmail.com

Site Name: Hospital Clinico Universitario De Valencia
Department Name: Oncology
Contact Person Name: Paloma Martin Martorell
Contact Person Email: paloma_martin@comv.es

Site Name: Hospital De La Santa Creu I Sant Pau (additional site entry)

Site Name: Other Spanish participating site

Hungary

Earliest CTIS Part Ii Submission Date: 18-02-2025
Latest Decision Or Authorization Date: 19-03-2025
Processing Time Days: 29
Number Of Sites: 3
Number Of Participants: 17

Sites

Site Name: Tolna Varmegyei Balassa Janos Korhaz
Department Name: Oncology
Contact Person Name: Yousuf Al-Farhat
Contact Person Email: yalfarhat@gmail.com

Site Name: University Of Debrecen
Department Name: Pulmonology
Contact Person Name: Ildikó Horváth
Contact Person Email: horvath.ildiko@med.unideb.hu

Site Name: Orszagos Koranyi Pulmonologiai Intezet
Contact Person Name: Gyula Ostoros
Contact Person Email: drostorosgyula@gmail.com

Lithuania

Earliest CTIS Part Ii Submission Date: 18-02-2025
Latest Decision Or Authorization Date: 13-03-2025
Processing Time Days: 23
Number Of Sites: 2
Number Of Participants: 13

Sites

Site Name: Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name: Department of Pulmonolgy
Contact Person Name: Marius Zemaitis
Contact Person Email: marius.zemaitis@kaunoklinikos.lt

Site Name: Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Department Name: Medical oncology department
Contact Person Name: Vaida Gedvilaite
Contact Person Email: ieva.kasiliauskaite@nvc.santa.lt

Ireland

Earliest CTIS Part Ii Submission Date: 11-02-2025
Latest Decision Or Authorization Date: 17-04-2025
Processing Time Days: 65
Number Of Sites: 4
Number Of Participants: 11

Sites

Site Name: Beaumont Hospital
Department Name: Oncology
Contact Person Name: Jarushka Naidoo
Contact Person Email: jarushkanaidoo@beaumont.ie

Site Name: Tallaght University Hospital
Department Name: Oncology
Contact Person Name: Sebastian Trainor
Contact Person Email: sebastian.trainor@tuh.ie

Site Name: Cork University Hospital
Department Name: Oncology
Contact Person Name: Hazel O'Sullivan
Contact Person Email: hazel.osullivan@hse.ie

Site Name: Mater Misericordiae University Hospital
Department Name: Oncology
Contact Person Name: Deirdre Kelly
Contact Person Email: deirdrekelly@mater.ie

Bulgaria

Earliest CTIS Part Ii Submission Date: 19-02-2025
Latest Decision Or Authorization Date: 17-03-2025
Processing Time Days: 26
Number Of Sites: 6
Number Of Participants: 24

Sites

Site Name: Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name: Department of Medical Oncology
Contact Person Name: Rossitza Krasteva
Contact Person Email: rossitza.krasteva@unihospitalbg.bg

Site Name: Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
Department Name: Department of Medical Oncology
Contact Person Name: Bonka Popova
Contact Person Email: dr.bonka.popova@gmail.com

Site Name: Multiprofile Hospital For Active Treatment Dobrich AD
Department Name: Department of Medical Oncology
Contact Person Name: Zyuhal Kasimova
Contact Person Email: dr.zyuhal.kasimova@gmail.com

Site Name: University Hospital St Marina Varna
Department Name: Clinic of Medical Oncology
Contact Person Name: Eleonora Dimitrova - Gospodinova
Contact Person Email: edimitrova_doc@avb.bg

Site Name: MBAL Serdika Ltd.
Department Name: Second Department of Medical Oncology
Contact Person Name: Krassimir Koynov
Contact Person Email: kdkoynov@yahoo.co.uk

Site Name: Complex Oncology Center Ruse EOOD
Department Name: Department of Medical Oncology
Contact Person Name: Valeriy Yordanov
Contact Person Email: dr_vjordanov@abv.bg

Belgium

Earliest CTIS Part Ii Submission Date: 18-02-2025
Latest Decision Or Authorization Date: 30-04-2025
Processing Time Days: 71
Number Of Sites: 3
Number Of Participants: 9

Sites

Site Name: Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name: Medical Oncology
Contact Person Name: Jean-Charles Goeminne
Contact Person Email: jean-charles.goeminne@chuuclnamur.uclouvain.be

Site Name: Universitair Ziekenhuis Antwerpen
Department Name: Thoracic Oncology
Contact Person Name: Reinier Wener
Contact Person Email: reinier.wener@uza.be

Site Name: Az Maria Middelares Gent
Department Name: Pulmonary Medicine
Contact Person Name: Paul Germonpré
Contact Person Email: Paul.Germonpre@mijnziekenhuis.be

Sponsor

Primary sponsor

Full Name: Immutep
Organisation Type: Pharmaceutical company
Country Of Registered Address: France

Contract research organisations

Name: Fortrea Inc.
Responsibilities: Operational CRO functions including site contracts, site payments, 24/7 medical coverage and multiple study operational roles (as listed in sponsor duties).

Name: Labcorp (Early Development Laboratories / Central Laboratory Services)
Responsibilities: Central laboratory and tissue analysis services.

Name: Clario
Responsibilities: eCOA provider.

Name: Charles River Laboratories Evreux
Responsibilities: Non-clinical/operational support (as listed in sponsor third-party duties).

Third parties

{"country":"Serbia","full_name":"Allucent d.o.o. Beograd","duties_or_roles":"Safety database","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"Patients' reimbursement, Investigator meetings","organisation_type":"Non-Pharmaceutical company"}
{"country":"France","full_name":"Charles River Laboratories Evreux","duties_or_roles":"Non-specified (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Multiple operational roles including site contracts, site payments, 24/7 medical coverage (sponsor duties listed including codes 1,2,3,4,5,8,9 and explicit value: 'Site contracts, Site payments, 24/7 Medical coverage')","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"Laboratory services (code 4)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory services (code 4)","organisation_type":"Pharmaceutical company"}
{"country":"Greece","full_name":"Fortrea Development Ltd. Branch Of Foreign Company","duties_or_roles":"Local clinical trial activities in Greece as applicable; operational support","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumour tissue analysis and laboratory services","organisation_type":"Pharmaceutical company"}
{"country":"Switzerland","full_name":"Clario","duties_or_roles":"eCOA","organisation_type":"Health care"}
{"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Electronic data systems (code 7)","organisation_type":"Non-Pharmaceutical company"}
{"country":"Romania","full_name":"Fortrea Development Limited Maidenhead Sucursala Bucuresti","duties_or_roles":"Local clinical trial activities in Romania as applicable","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"BioKryo GmbH","duties_or_roles":"Samples storage","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging review","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Data management / other (code 3)","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Pharmaspecific","duties_or_roles":"Patients' reimbursement","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: IMP321
Active Substance: EFTILAGIMOD ALFA
Modality: Peptide/protein/enzyme
Routes Of Administration: SUBCUTANEOUS USE
Route: Subcutaneous
Authorisation Status: Investigational / prodAuthStatus 1
Maximum Dose: 30 mg (maxDailyDoseAmount: 30 mg)

Investigational Product Name: KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance: PEMBROLIZUMAB
Modality: Monoclonal antibody
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation present, prodAuthStatus 2)
Maximum Dose: 200 mg (maxDailyDoseAmount: 200 mg)

Investigational Product Name: PACLITAXEL
Active Substance: PACLITAXEL
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (prodAuthStatus 2)
Maximum Dose: 200 mg/m2 (maxDailyDoseAmount: 200 mg/m2)

Investigational Product Name: CISPLATIN
Active Substance: CISPLATIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (prodAuthStatus 2)
Maximum Dose: 75 mg/m2 (maxDailyDoseAmount: 75 mg/m2)

Investigational Product Name: CARBOPLATIN
Active Substance: CARBOPLATIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (prodAuthStatus 2)
Maximum Dose: 870 mg (maxDailyDoseAmount: 870 mg)

Investigational Product Name: Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
Active Substance: PEMETREXED
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised (prodAuthStatus 2)
Maximum Dose: 500 mg/m2 (maxDailyDoseAmount: 500 mg/m2)

Investigational Product Name: Efti-matching placebo (placebo is matching the appearance and injection characteristics of efti but does not contain active substance).
Modality: Other

Combination Treatment: Yes

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