Clinical trial • Phase II • Oncology
REGN7075 for Non-small cell lung cancer
Phase II trial of REGN7075 for Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Bispecific antibody|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 03-07-2024
- First CTIS Authorization Date
- 08-10-2024
Trial design
Randomised, cemiplimab plus chemotherapy versus cemiplimab plus chemotherapy plus other cancer treatments. control/comparator arm: cemiplimab plus chemotherapy (cemiplimab/libtayo with chemotherapy agents listed in auxiliary products such as pemetrexed, cisplatin, carboplatin, paclitaxel). investigational arms: cemiplimab plus chemotherapy plus novel anti-cancer agents (e.g., regn7075 and other investigational agents). doses and schedules not specified in the ctis record. Phase II trial across 28 sites in France, Spain, Germany.
- Randomised
- Yes
- Comparator
- Cemiplimab plus chemotherapy versus cemiplimab plus chemotherapy plus other cancer treatments. Control/comparator arm: cemiplimab plus chemotherapy (cemiplimab/LIBTAYO with chemotherapy agents listed in auxiliary products such as pemetrexed, cisplatin, carboplatin, paclitaxel). Investigational arms: cemiplimab plus chemotherapy plus novel anti-cancer agents (e.g., REGN7075 and other investigational agents). Doses and schedules not specified in the CTIS record.
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population selected. Informed consent will be obtained using Subject Information Sheets and Informed Consent Forms (multiple versions available: Main, EGFR Sub-study, PGx, PP, FBR). Participants provide consent; no paediatric assent procedures are described..
- Vulnerable Population
- Vulnerable population selected. Informed consent will be obtained using Subject Information Sheets and Informed Consent Forms (multiple versions available: Main, EGFR Sub-study, PGx, PP, FBR). Participants provide consent; no paediatric assent procedures are described.
Inclusion criteria
- {"criterion_text":"-Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol"}
- {"criterion_text":"-Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1"}
- {"criterion_text":"-Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol"}
- {"criterion_text":"-Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1"}
- {"criterion_text":"-Adequate organ and bone marrow function, as described in the protocol"}
- {"criterion_text":"-Note: Other protocol-defined Inclusion criteria apply."}
Exclusion criteria
- {"criterion_text":"-Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol"}
- {"criterion_text":"-Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol"}
- {"criterion_text":"-Presence of ≥ grade 2 peripheral neuropathy"}
- {"criterion_text":"-Another malignancy that is progressing or requires active treatment, as described in the protocol Arm"}
- {"criterion_text":"-Investigational arm 1 - Grade ≥3 hypercalcemia, as defined in the protocol"}
- {"criterion_text":"-Investigational arm 1 - Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol"}
- {"criterion_text":"-Investigational arm 1 - Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol"}
- {"criterion_text":"-Note: Other protocol-defined Exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)","definition_or_measurement_approach":"As determined by central blinded independent pathology review (BIPR)"}
Secondary endpoints
- {"endpoint_text":"-Pathologic complete response (pCR) rate as determined by central BIPR","definition_or_measurement_approach":"As determined by central blinded independent pathology review (BIPR)"}
- {"endpoint_text":"-Residual viable tumor (RVT) as determined by central BIPR","definition_or_measurement_approach":"As determined by central blinded independent pathology review (BIPR)"}
- {"endpoint_text":"-Median event-free survival (EFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"-EFS rate","definition_or_measurement_approach":""}
- {"endpoint_text":"-Objective response rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Overall survival (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Severity of TEAEs","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of TEAEs leading to death","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of TEAEs leading to treatment discontinuation","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of serious adverse events (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of adverse events of special interest (AESIs)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of immune-mediated adverse events (imAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of infusion-related reactions (IRRs)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of grade ≥3 laboratory abnormalities","definition_or_measurement_approach":""}
- {"endpoint_text":"-Proportion of delayed surgeries due to TEAEs","definition_or_measurement_approach":""}
- {"endpoint_text":"-Proportion of cancelled surgeries due to TEAEs","definition_or_measurement_approach":""}
- {"endpoint_text":"-Incidence of anti-drug antibodies (ADAs) to cemiplimab over time","definition_or_measurement_approach":"Incidence measured over time (ADA testing schedule not detailed here)"}
- {"endpoint_text":"-Titer of ADAs to cemiplimab over time","definition_or_measurement_approach":"Titer measured over time (specific assay details not provided here)"}
- {"endpoint_text":"-Incidence of ADAs to novel anti-cancer agents over time","definition_or_measurement_approach":"Incidence measured over time (ADA testing schedule not detailed here)"}
- {"endpoint_text":"-Titer of ADAs to novel anti-cancer agents over time","definition_or_measurement_approach":"Titer measured over time (specific assay details not provided here)"}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 40
- Recruitment Window Months
- 67
- Consent Approach
- Informed consent obtained using Subject Information Sheets and Informed Consent Forms (multiple ICF documents listed: Main, EGFR Sub-study, PGx, PP, FBR). Consent is provided by participants (adults). Multiple language and country-specific versions of ICF and information materials are available (documents and protocol synopses in English, Spanish, French, German and country-specific recruitment materials). No paediatric/assent procedures described.
Methods
- Internet banner ads (documents: Banner Ads Layout, internet banner materials) — targeted at potential patient audience / public-facing recruitment
- Basic study website (documents: Basic Website, Basic Website 5 pg) — online information for prospective participants (country/language-specific versions present)
- Patient email layout (documents: Patient Email Layout) — direct email communication templates to patients
- Posters and recruitment leaflets (documents: Poster Layout, Recruitment Leaflet Layout, Study Brochure Layout) — site-based printed materials for patients
- Storyboard / video concept (documents: Neo-Empower Storyboard) — multimedia recruitment content
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 40
France
- Earliest CTIS Part Ii Submission Date
- 25-09-2024
- Latest Decision Or Authorization Date
- 22-09-2025
- Processing Time Days
- 362
- Number Of Sites
- 11
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Medical Pneumology
- Principal Investigator Name
- Sophie Schneider
- Principal Investigator Email
- sschneider@ch-cotebasque.fr
- Contact Person Name
- Sophie Schneider
- Contact Person Email
- sschneider@ch-cotebasque.fr
- Site Name
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
- Department Name
- Oncology Department
- Principal Investigator Name
- Clarisse Audigier-Valette
- Principal Investigator Email
- clarisse.audigier-valette@ch-toulon.fr
- Contact Person Name
- Clarisse Audigier-Valette
- Contact Person Email
- clarisse.audigier-valette@ch-toulon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Thoracic Oncology Unit
- Principal Investigator Name
- Patricia Barre
- Principal Investigator Email
- p-barre@chu-montpellier.fr
- Contact Person Name
- Patricia Barre
- Contact Person Email
- p-barre@chu-montpellier.fr
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Satellite site Pneumology Department
- Principal Investigator Name
- Nicolas Girard
- Principal Investigator Email
- nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Pneumology Department
- Principal Investigator Name
- Herve Lena
- Principal Investigator Email
- herve.lena@chu-rennes.fr
- Contact Person Name
- Herve Lena
- Contact Person Email
- herve.lena@chu-rennes.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Satellite site Oncology Department
- Principal Investigator Name
- Maciej Rotarski
- Principal Investigator Email
- maciej.rotarski@copb.eu
- Contact Person Name
- Maciej Rotarski
- Contact Person Email
- maciej.rotarski@copb.eu
- Site Name
- HIA Sainte Anne
- Department Name
- Satellite site Pneumology Department
- Principal Investigator Name
- Clarisse Audigier-Valette
- Principal Investigator Email
- clarisse.audigier-valette@ch-toulon.fr
- Contact Person Name
- Clarisse Audigier-Valette
- Contact Person Email
- clarisse.audigier-valette@ch-toulon.fr
- Site Name
- Ramsay Generale De Sante
- Department Name
- Oncology Department
- Principal Investigator Name
- Maciej Rotarski
- Principal Investigator Email
- maciej.rotarski@copb.eu
- Contact Person Name
- Maciej Rotarski
- Contact Person Email
- maciej.rotarski@copb.eu
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philippe Rochigneux
- Principal Investigator Email
- rochigneuxp@ipc.unicancer.fr
- Contact Person Name
- Philippe Rochigneux
- Contact Person Email
- rochigneuxp@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Thoracic oncology unit
- Principal Investigator Name
- Denis Moro-Sibilot
- Principal Investigator Email
- Dmoro-Sibilot@chu-grenoble.fr
- Contact Person Name
- Denis Moro-Sibilot
- Contact Person Email
- Dmoro-Sibilot@chu-grenoble.fr
- Site Name
- Institut Curie
- Department Name
- Pneumology Department
- Principal Investigator Name
- Nicolas Girard
- Principal Investigator Email
- nicolas.girard2@curie.fr
- Contact Person Name
- Nicolas Girard
- Contact Person Email
- nicolas.girard2@curie.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 414
- Number Of Sites
- 12
- Number Of Participants
- 20
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology Service
- Principal Investigator Name
- Miguel Fernandez de Sanmamed Gutierrez
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez de Sanmamed Gutierrez
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology Service
- Principal Investigator Name
- Delvys Rodriguez Abreu
- Principal Investigator Email
- Drodabr@gobiernodecanarias.org
- Contact Person Name
- Delvys Rodriguez Abreu
- Contact Person Email
- Drodabr@gobiernodecanarias.org
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology Service
- Principal Investigator Name
- Gema Maria Garcia Ledo
- Principal Investigator Email
- gmgarcialedo@hmhospitales.com
- Contact Person Name
- Gema Maria Garcia Ledo
- Contact Person Email
- gmgarcialedo@hmhospitales.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncology Service
- Principal Investigator Name
- Paloma Martin Martorell
- Principal Investigator Email
- paloma_martin@comv.es
- Contact Person Name
- Paloma Martin Martorell
- Contact Person Email
- paloma_martin@comv.es
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Oncology Service
- Principal Investigator Name
- Paula Espinosa Olarte
- Principal Investigator Email
- paula.espinosa.olarte@gmail.com
- Contact Person Name
- Paula Espinosa Olarte
- Contact Person Email
- paula.espinosa.olarte@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology Service
- Principal Investigator Name
- Marta Lopez-Brea Piqueras
- Principal Investigator Email
- mlopez@humv.es
- Contact Person Name
- Marta Lopez-Brea Piqueras
- Contact Person Email
- mlopez@humv.es
- Site Name
- MD Anderson Cancer Center
- Department Name
- Oncology Service
- 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
- Hospital Universitario La Paz
- Department Name
- Oncology Service
- Principal Investigator Name
- Francisco Javier De Castro Carpeño
- Principal Investigator Email
- javier.decastro@salud.madrid.org
- Contact Person Name
- Francisco Javier De Castro Carpeño
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology Service
- Principal Investigator Name
- Carlos Aguado De La Rosa
- Principal Investigator Email
- carlos.aguadodela@salud.madrid.org
- Contact Person Name
- Carlos Aguado De La Rosa
- Contact Person Email
- carlos.aguadodela@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology Service
- Principal Investigator Name
- Reyes Bernabe Caro
- Principal Investigator Email
- mariar.bernabe.sspa@juntadeandalucia.es
- Contact Person Name
- Reyes Bernabe Caro
- Contact Person Email
- mariar.bernabe.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Oncology Service
- Principal Investigator Name
- Maria Dolores Isla Casado
- Principal Investigator Email
- ihuercanos@iisaragon.es
- Contact Person Name
- Maria Dolores Isla Casado
- Contact Person Email
- ihuercanos@iisaragon.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology Service
- Principal Investigator Name
- Enric Carcereny Costa
- Principal Investigator Email
- ecarcereny@iconcologia.net
- Contact Person Name
- Enric Carcereny Costa
- Contact Person Email
- ecarcereny@iconcologia.net
Germany
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 421
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Department of Hematology and Medical Oncology
- Principal Investigator Name
- Tobias Overbeck
- Principal Investigator Email
- tobias.overbeck@med.uni-goettingen.de
- Contact Person Name
- Tobias Overbeck
- Contact Person Email
- tobias.overbeck@med.uni-goettingen.de
- Site Name
- Klinikum Kassel GmbH
- Department Name
- Klinik für Hämatologie, Onkologie und Immunologie
- Principal Investigator Name
- Daniela Dörfel
- Principal Investigator Email
- daniela.doerfel@gnh.net
- Contact Person Name
- Daniela Dörfel
- Contact Person Email
- daniela.doerfel@gnh.net
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Department of Hematology, Hemostaseology and Stem Cell Transplantation
- Principal Investigator Name
- Martin Kirschner
- Principal Investigator Email
- mkirschner@ukaachen.de
- Contact Person Name
- Martin Kirschner
- Contact Person Email
- mkirschner@ukaachen.de
- Site Name
- Universitaet Leipzig
- Department Name
- Respiratory Medicine
- Principal Investigator Name
- Hubert Wirtz
- Principal Investigator Email
- hubert.wirtz@medizin.uni-leipzig.de
- Contact Person Name
- Hubert Wirtz
- Contact Person Email
- hubert.wirtz@medizin.uni-leipzig.de
- Site Name
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
- Department Name
- Department of Pneumology
- Principal Investigator Name
- Karsten Schulmann
- Principal Investigator Email
- Karsten.schulmann@lkhemer.de
- Contact Person Name
- Karsten Schulmann
- Contact Person Email
- Karsten.schulmann@lkhemer.de
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- CRO
Third parties
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Recruitment materials","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Logistics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"IDMC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Rad Md LLC","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"Central Lab","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- REGN7075
- Active Substance
- REGN7075
- Modality
- Bispecific antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Investigational (no marketing authorisation listed)
- Investigational Product Name
- LIBTAYO 350 mg concentrate for solution for infusion.
- Active Substance
- CEMIPLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Marketing authorisation present (EU)
- Combination Treatment
- Yes
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