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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509806-31-00 | Registry Identifier | EU CT Number |
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This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned.
The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
The study is also looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy+Cemiplimab | Active Comparator | Control treatment |
|
| Arm 1: Chemotherapy+Cemiplimab+REGN7075 | Experimental | Investigational Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemiplimab | Drug | Intravenous (IV) infusion administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR) | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (pCR) rate as determined by central BIPR | Up to 12 weeks | |
| Residual viable tumor (RVT) as determined by central BIPR | Up to 12 weeks | |
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General Key Inclusion Criteria:
General Key Exclusion Criteria:
Arm Specific Exclusion Criteria:
Arm 1:
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Recruiting | Orange | California | 92868 | United States | |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Platinum-based chemotherapy | Drug | IV infusion |
|
| REGN7075 | Drug | IV infusion |
|
|
| Median event-free survival (EFS) |
| Up to 5 years |
| EFS rate | Up to 5 years |
| Objective response rate (ORR) | Up to 9 weeks |
| Overall survival (OS) | Up to 5 years |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 76 weeks |
| Severity of TEAEs | Up to 76 weeks |
| Incidence of TEAEs leading to death | Up to 76 weeks |
| Incidence of TEAEs leading to treatment discontinuation | Up to 76 weeks |
| Incidence of serious adverse events (SAEs) | Up to 76 weeks |
| Incidence of adverse events of special interest (AESIs) | Up to 76 weeks |
| Incidence of immune-mediated adverse events (imAEs) | Up to 76 weeks |
| Incidence of infusion-related reactions (IRRs) | Up to 76 weeks |
| Incidence of grade ≥3 laboratory abnormalities | As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) | Up to 76 weeks |
| Proportion of delayed surgeries due to TEAEs | Up to 76 weeks |
| Proportion of cancelled surgeries due to TEAEs | Up to 76 weeks |
| Incidence of anti-drug antibodies (ADAs) to cemiplimab over time | Up to 67 weeks |
| Titer of ADAs to cemiplimab over time | Up to 67 weeks |
| Incidence of ADAs to novel anti-cancer agents over time | Up to 67 weeks |
| Titer of ADAs to novel anti-cancer agents over time | Up to 67 weeks |
| Orchard Healthcare Research Inc. |
| Recruiting |
| Skokie |
| Illinois |
| 60077 |
| United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| Detroit Clinical Research Center | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| Morristown Medical Center | Recruiting | Morristown | New Jersey | 07960 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Oncology Hematology Care Clinical Trials LLC | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
| University Of Nebraska Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
| Lifespan Cancer Institute | Recruiting | Providence | Rhode Island | 02903 | United States |
| Prairie Lakes Healthcare System | Recruiting | Watertown | South Dakota | 57201 | United States |
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Sarah Cannon Research Institute (SCRI) Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
| BRCC/Oncology & Hematology Associates of SW Virginia | Recruiting | Blacksburg | Virginia | 24060 | United States |
| Oncology Clinical Research Center | Recruiting | Cachoeiro de Itapemirim | Espírito Santo | 29306014 | Brazil |
| Instituto Mario Penna | Recruiting | Belo Horizonte | Minas Gerais | 30380-472 | Brazil |
| Instituto Sul Mineiro De Oncologia LTDA | Recruiting | Pouso Alegre | Minas Gerais | 37554-238 | Brazil |
| Instituto de Medicina Integral Professor Fernando Figueira | Recruiting | Recife | Pernambuco | 50070-902 | Brazil |
| Liga Norte Riograndense Contra o Cancer | Recruiting | Natal | Rio Grande do Norte | 59060-195 | Brazil |
| Hospital Mae de Deus Integrated Oncology Center | Recruiting | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Hospital Sao Lucas da PUCRS | Recruiting | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Ynova Pesquisa Clinica | Recruiting | Florianópolis | Santa Catarina | 88020-210 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Unimed Sorocaba | Recruiting | Sorocaba | São Paulo | 18065-100 | Brazil |
| Hospital Alemao Oswaldo Cruz | Recruiting | São Paulo | 01323-903 | Brazil |
| CHU Rennes | Recruiting | Rennes | Brittany Region | 35033 | France |
| Centre Hospitalier Intercommunal Toulon - CHITS | Recruiting | Toulon | Var | 83055 | France |
| Centre Hospitalier de la Cote Basque | Recruiting | Bayonne | 64100 | France |
| Clinique Belharra | Recruiting | Bayonne | 64100 | France |
| CHU Grenoble Alpes | Recruiting | Grenoble | 38330 | France |
| Montpellier Academic Hospital | Recruiting | Montpellier | 34295 | France |
| Institut Curie | Recruiting | Paris | Île-de-France Region | 75005 | France |
| Klinikum Kassel GmbH, Hauttumorzentrum | Recruiting | Kassel | Hesse | 34125 | Germany |
| University Medicine Gottingen | Recruiting | Göttingen | Lower Saxony | 37083 | Germany |
| University of Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
| University Hospital RWTH Aachen | Recruiting | Aachen | 52074 | Germany |
| Catalan Instituye of Oncology Badalona | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Hospital Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Insular de Gran Canaria | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| MD Anderson Cancer Center | Recruiting | Madrid | 28033 | Spain |
| Hospital Universitario Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| Hospital Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Clinico Universitario Valencia | Recruiting | Valencia | 46010 | Spain |
| Consorci Hospital General Universitario de Valencia | Recruiting | Valencia | 46014 | Spain |
| Hospital Clinico Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| Florya Medical Park Hospital | Recruiting | Istanbul | 34295 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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