Clinical trial • Phase II • Oncology
PEMBROLIZUMAB for Non-small cell lung cancer
Phase II trial of PEMBROLIZUMAB for Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Other antibody
Key dates
- Initial CTIS Submission Date
- 22-08-2024
- First CTIS Authorization Date
- 19-09-2024
Trial design
Randomised, open-label, randomized arms include gen1046 (acasunlimab) monotherapy and gen1046 in combination with pembrolizumab (keytruda). doses and schedules are not specified in the ctis record.-controlled Phase II trial in France, Poland, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Randomized arms include GEN1046 (Acasunlimab) monotherapy and GEN1046 in combination with Pembrolizumab (KEYTRUDA). Doses and schedules are not specified in the CTIS record.
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable population selected. All participants must sign a written informed consent form (ICF). CTIS documents include subject information and ICF materials including specific documents for pregnant participants and pregnant partners; minimum age for enrolment is 18 years so no assent for minors is described in the CTIS record..
- Vulnerable Population
- Vulnerable population selected. All participants must sign a written informed consent form (ICF). CTIS documents include subject information and ICF materials including specific documents for pregnant participants and pregnant partners; minimum age for enrolment is 18 years so no assent for minors is described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Subject must sign an informed consent form (ICF)\n- Subject must be at least 18 years of age on the day of signing the ICF\n- Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 -mAb for metastatic disease.\n- Subject must have a tumor PD-L1 expression result available prior to C1D1 demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a sponsor designated central laboratory using the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%), or per site local assessment with the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%) or the VENTANA PD-L1 (SP263) assay (TC ≥1%) adhering to the manufacturer’s instructions. Note: Local PD-L1 result needs to be performed on fresh tumor tissue (obtained within 3 months prior to enrollment and after failure/stop of last prior treatment) or, if not feasible, archival tissue (obtained within 12 months prior to enrollment).\n- Subject must have measurable disease per RECIST v1.1 as assessed by the investigator.\n- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.\n- Subject must have life expectancy of at least 3 months\n- Subject must have adequate organ and bone marrow function as described in the protocol."}
Exclusion criteria
- {"criterion_text":"- Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements, highlevel MET amplification, or METex 14 skipping\n- Subject has been exposed to any of the following prior therapies: •Prior treatment with docetaxel for NSCLC •Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, or autologous cell immunotherapy, •Treatment with an anti-cancer agent within 28 daysrior to GEN1046 administration."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator","definition_or_measurement_approach":"Assessed by investigator according to RECIST v1.1"}
Secondary endpoints
- {"endpoint_text":"- Duration of response (DOR) per RECIST v1.1. -","definition_or_measurement_approach":"According to RECIST v1.1"}
- {"endpoint_text":"- Time to response (TTR) per RECIST v1.1.","definition_or_measurement_approach":"According to RECIST v1.1"}
- {"endpoint_text":"- Progression-free survival (PFS) per RECIST v1.1","definition_or_measurement_approach":"According to RECIST v1.1"}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Measured as overall survival (time to death from any cause)"}
- {"endpoint_text":"- Incidence and severity of adverse events (AEs)","definition_or_measurement_approach":"Incidence and severity collected and reported per protocol (adverse event reporting)"}
- {"endpoint_text":"- Incidence and severity of laboratory abnormalities","definition_or_measurement_approach":"Laboratory abnormalities incidence and severity as defined in protocol"}
Other endpoints
- {"endpoint_text":"- Tolerability, Immunogenicity, Biomarker Analyses, Health-related Quality of life","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 65
- Consent Approach
- Written informed consent required: 'Subject must sign an informed consent form (ICF)'. ICF and subject information (SIS) documents are available in multiple languages (English, French, Spanish, Italian, Polish, Portuguese, Dutch) and include specific ICF/SIS materials for pregnant participants and pregnant partners. Minimum enrolment age is 18 years; no assent procedures for minors are described in the CTIS record.
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 100
France
- Latest Decision Or Authorization Date
- 07-10-2024
- Number Of Sites
- 7
- Number Of Participants
- 23
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Institut de Cancérologie et d hematology
- Principal Investigator Name
- Gilles QUERE
- Principal Investigator Email
- gilles.quere@chu-brest.fr
- Contact Person Name
- Gilles QUERE
- Contact Person Email
- gilles.quere@chu-brest.fr
- Site Name
- Unite De Recherche Clinique HIA Begin
- Department Name
- Unite de Recherche Clinique
- Principal Investigator Name
- Hugo PICCHI
- Principal Investigator Email
- picchi.hugo90@gmail.com
- Contact Person Name
- Hugo PICCHI
- Contact Person Email
- picchi.hugo90@gmail.com
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Principal Investigator Name
- Roland SCHOTT
- Principal Investigator Email
- r.schott@icans.eu
- Contact Person Name
- Roland SCHOTT
- Contact Person Email
- r.schott@icans.eu
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Florian GUISIER
- Principal Investigator Email
- florian.guisier@chu-rouen.fr
- Contact Person Name
- Florian GUISIER
- Contact Person Email
- florian.guisier@chu-rouen.fr
- Site Name
- Institut Bergonie
- Department Name
- Departement de Medecine Oncologique
- Principal Investigator Name
- Sophie COUSIN
- Principal Investigator Email
- s.cousin@bordeaux.unicancer.fr
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement de Medecine Oncologique
- Principal Investigator Name
- Benjamin BESSE
- Principal Investigator Email
- benjamin.besse@gustaveroussy.fr
- Contact Person Name
- Benjamin BESSE
- Contact Person Email
- benjamin.besse@gustaveroussy.fr
- Site Name
- Hospital Foch
- Department Name
- Departement d’Oncologie
- Principal Investigator Name
- Anne-Cecile METIVIER
- Principal Investigator Email
- ac.metivier@hopital-foch.com
- Contact Person Name
- Anne-Cecile METIVIER
- Contact Person Email
- ac.metivier@hopital-foch.com
Poland
- Latest Decision Or Authorization Date
- 28-10-2024
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Szpital Specjalistyczny W Prabutach Sp. z o.o.
- Department Name
- Oddział Pulmonologii
- Principal Investigator Name
- Anna Lowczak
- Principal Investigator Email
- onkoania@gazeta.pl
- Contact Person Name
- Anna Lowczak
- Contact Person Email
- onkoania@gazeta.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Principal Investigator Name
- Dariusz Kowalski
- Principal Investigator Email
- dariusz.kowalski@pib-nio.pl
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- dariusz.kowalski@pib-nio.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Principal Investigator Name
- Andrzej Kazarnowicz
- Principal Investigator Email
- andrzej_kazarnowicz@wp.pl
- Contact Person Name
- Andrzej Kazarnowicz
- Contact Person Email
- andrzej_kazarnowicz@wp.pl
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
Spain
- Latest Decision Or Authorization Date
- 19-09-2024
- Number Of Sites
- 9
- Number Of Participants
- 26
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Luis Paz-Ares Rodríguez
- Principal Investigator Email
- lpazares@hotmail.com
- Contact Person Name
- Luis Paz-Ares Rodríguez
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Immunology and Immunotherapy
- Principal Investigator Name
- Miguel Fernández de Sanmamed Gutiérrez
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernández de Sanmamed Gutiérrez
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology Department
- Principal Investigator Name
- Enriqueta Felip
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jose Carlos Benitez-Montanez
- Principal Investigator Email
- jcbenitez.huvv@gmail.com
- Contact Person Name
- Jose Carlos Benitez-Montanez
- Contact Person Email
- jcbenitez.huvv@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sergio Sandiego
- Principal Investigator Email
- ssandiego@fivo.org
- Contact Person Name
- Sergio Sandiego
- Contact Person Email
- ssandiego@fivo.org
- Site Name
- MD Anderson Cancer Center
- Department Name
- Medical Oncology
- Principal Investigator Name
- Fernando Fabio Franco Perez
- Principal Investigator Email
- ffranco@fundacionmdanderson.es
- Contact Person Name
- Fernando Fabio Franco Perez
- Contact Person Email
- ffranco@fundacionmdanderson.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Immunology and Immunotherapy
- Principal Investigator Name
- Miguel Fernández de Sanmamed Gutiérrez
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernández de Sanmamed Gutiérrez
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Manuel Domine Gomez
- Principal Investigator Email
- manueldomine@gmail.com
- Contact Person Name
- Manuel Domine Gomez
- Contact Person Email
- manueldomine@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Amelia Insa Molla
- Principal Investigator Email
- amelia.insa@ono.com
- Contact Person Name
- Amelia Insa Molla
- Contact Person Email
- amelia.insa@ono.com
Germany
- Latest Decision Or Authorization Date
- 25-09-2024
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik fuer Pneumologie – Pneumo-Onkologie
- Principal Investigator Name
- Heiko Golpon
- Principal Investigator Email
- Golpon.Heiko@mh-hannover.de
- Contact Person Name
- Heiko Golpon
- Contact Person Email
- Golpon.Heiko@mh-hannover.de
- Site Name
- Lungenfachklinik Immenhausen
- Principal Investigator Name
- Achim Rittmeyer
- Principal Investigator Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Medizinische Klinik IV, Organonkologie (OON)
- Principal Investigator Name
- Thomas Wehler
- Principal Investigator Email
- thomas.wehler@innere.med.uni-giessen.de
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- thomas.wehler@innere.med.uni-giessen.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Pneumologie
- Principal Investigator Name
- Christian Schulz
- Principal Investigator Email
- christian.schulz@klinik.uni-regensburg.de
- Contact Person Name
- Christian Schulz
- Contact Person Email
- christian.schulz@klinik.uni-regensburg.de
Netherlands
- Latest Decision Or Authorization Date
- 19-09-2024
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Pulmonary department
- Principal Investigator Name
- Sayed Hashemi
- Principal Investigator Email
- s.hashemi@amsterdamumc.nl
- Contact Person Name
- Sayed Hashemi
- Contact Person Email
- s.hashemi@amsterdamumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmonary department
- Principal Investigator Name
- Joachim Aerts
- Principal Investigator Email
- j.aerts@erasmusmc.nl
- Contact Person Name
- Joachim Aerts
- Contact Person Email
- j.aerts@erasmusmc.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Egbert Smit
- Principal Investigator Email
- e.f.smit@LUMC.nl
- Contact Person Name
- Egbert Smit
- Contact Person Email
- e.f.smit@LUMC.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Pulmonary department
- Principal Investigator Name
- Willemijn Theelen
- Principal Investigator Email
- w.theelen@nki.nl
- Contact Person Name
- Willemijn Theelen
- Contact Person Email
- w.theelen@nki.nl
Italy
- Latest Decision Or Authorization Date
- 04-11-2024
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Oncology-Hematology Department
- Principal Investigator Name
- Manolo D’Arcangelo
- Principal Investigator Email
- manolo.darcangelo@auslromagna.it
- Contact Person Name
- Manolo D’Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Division of Medical Oncology 2
- Principal Investigator Name
- Federico Cappuzzo
- Principal Investigator Email
- federico.cappuzzo@ifo.gov.it
- Contact Person Name
- Federico Cappuzzo
- Contact Person Email
- federico.cappuzzo@ifo.gov.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hector Soto Parra
- Principal Investigator Email
- hsotoparra@policlinico.unict.it
- Contact Person Name
- Hector Soto Parra
- Contact Person Email
- hsotoparra@policlinico.unict.it
- Site Name
- La Maddalena S.p.A.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Carmelo Carlo Arcara
- Principal Investigator Email
- carloarcara75@gmail.com
- Contact Person Name
- Carmelo Carlo Arcara
- Contact Person Email
- carloarcara75@gmail.com
- Site Name
- Azienda Sociosanitaria 3
- Department Name
- Medical Oncology
- Principal Investigator Name
- Paola Adriana Taveggia
- Principal Investigator Email
- Taveggia.Paola@asl3.liguria.it
- Contact Person Name
- Paola Adriana Taveggia
- Contact Person Email
- Taveggia.Paola@asl3.liguria.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Division of Medical Oncology and Hematology
- Principal Investigator Name
- Fortunato Ciardiello
- Principal Investigator Email
- fortunato.ciardiello@unicampania.it
- Contact Person Name
- Fortunato Ciardiello
- Contact Person Email
- fortunato.ciardiello@unicampania.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Thoracic Oncology Division
- Principal Investigator Name
- Filippo De Marinis
- Principal Investigator Email
- filippo.demarinis@ieo.it
- Contact Person Name
- Filippo De Marinis
- Contact Person Email
- filippo.demarinis@ieo.it
Portugal
- Latest Decision Or Authorization Date
- 24-09-2024
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- António Ferreira-Araújo
- Principal Investigator Email
- antonio.araujo@chporto.min-saude.pt
- Contact Person Name
- António Ferreira-Araújo
- Contact Person Email
- antonio.araujo@chporto.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Pneumology
- Principal Investigator Name
- Lurdes Ferreira
- Principal Investigator Email
- maria.lurdes.ferreira@hb.min-saude.pt
- Contact Person Name
- Lurdes Ferreira
- Contact Person Email
- maria.lurdes.ferreira@hb.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Pneumology
- Principal Investigator Name
- Teresa Almodovar
- Principal Investigator Email
- talmodovar@ipolisboa.min-saude.pt
- Contact Person Name
- Teresa Almodovar
- Contact Person Email
- talmodovar@ipolisboa.min-saude.pt
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Lung Unit
- Principal Investigator Name
- Nuno Gil
- Principal Investigator Email
- nuno.gil@fundacaochampalimaud.pt
- Contact Person Name
- Nuno Gil
- Contact Person Email
- nuno.gil@fundacaochampalimaud.pt
Sponsor
Primary sponsor
- Full Name
- Genmab A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Syneos Health Netherlands B.V.
- Name
- Clinipace Inc.
- Name
- Almac Clinical Services LLC
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Imaging, eCOA
- Name
- Celerion Inc.
- Responsibilities
- PK and ADA analysis
Third parties
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Analysis of TMB/ctDNA Samples","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"PK and ADA analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"T-cell receptor (TCR) profiling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Tumor biopsy (PD-L1 expression)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Imaging, eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"DNA/RNA sequencing","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Licensed/Marketing authorisation (EU/1/15/1024/002)
- Maximum Dose
- 400 mg (max daily dose amount per CTIS record)
- Investigational Product Name
- Acasunlimab
- Active Substance
- ACASUNLIMAB
- Modality
- Other antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Investigational product (no marketing authorisation indicated in CTIS record)
- Maximum Dose
- 500 mg (max daily dose amount per CTIS record)
- Combination Treatment
- Yes
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