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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505172-29-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery.
The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab |
|
| Arm B | Experimental | Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab |
|
| Arm C | Experimental | Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fianlimab | Drug | Administered intravenously (IV) every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) | Up to 3 years | |
| Major pathological response (MPR) by BIPR in post-treatment resected tumor samples | Up to 24 months | |
| MPR by local pathology review in post-treatment resected tumor samples |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont Oncology Center | Clermont | Florida | 34711 | United States | ||
| University of Illinois |
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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| Cemiplimab | Drug | Administered IV Q3W |
|
|
| Pemetrexed | Drug | Administered IV Q3W |
|
|
| Paclitaxel | Drug | Administered IV Q3W |
|
|
| Carboplatin | Drug | Administered IV Q3W |
|
|
| Cisplatin | Drug | Administered IV Q3W |
|
|
| Placebo | Drug | Administered IV Q3W |
|
| Up to 24 months |
| Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment | Up to 24 months |
| Occurrence of Adverse events (AEs) | Up to 5 years |
| Occurrence of Treatment-emergent adverse event (TEAEs) | Up to 5 years |
| Occurrence of Serious adverse events (SAEs) | Up to 5 years |
| Occurrence of Adverse events of special interest (AESIs) | Up to 5 years |
| Occurrence of immune-mediated adverse events (imAEs) | Up to 5 years |
| Occurrence of interruption and discontinuation of study drug(s) due to TEAE | Up to 5 years |
| Occurrence of laboratory abnormalities | Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests | Up to 5 years |
| Occurrence of death due to TEAE | Up to 5 years |
| Concentrations of cemiplimab in serum | Up to 30 months |
| Concentrations of fianlimab in serum | Up to 30 months |
| Anti-drug antibodies (ADA) to fianlimab in serum over time | Up to 30 months |
| ADA to cemiplimab in serum over time | Up to 30 months |
| Percentage of patients with definitive surgery | Up to 24 months |
| Percentage of patients with cancelled surgery | Up to 24 months |
| Percentage of patients with delayed surgery | Up to 24 months |
| Completeness of resection (R0, R1, R2, Rx) | Up to 24 months |
| Length in delay of surgery | Up to 24 months |
| Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other) | Up to 24 months |
| Median length of hospital stay | Up to 24 months |
| Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy) | Up to 24 months |
| Incidence of peri operative AE associated with surgery | Up to 90 days post-surgery |
| Incidence of peri operative SAE associated with surgery | Up to 90 days post-surgery |
| Incidence of post operative AE associated with surgery | Up to 90 days post-surgery |
| Incidence of post operative SAE associated with surgery | Up to 90 days post-surgery |
| Overall change in patient-reported global health status/QoL per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. | Up to 5 years |
| Overall change in patient-reported physical functioning per EORTC QLQ-C30 | Up to 5 years |
| Overall change in patient-reported role functioning per EORTC QLQ-C30 | Up to 5 years |
| Overall change in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome. | Up to 5 years |
| Overall change in patient-reported dyspnea per EORTC QLQ-LC13 | Up to 5 years |
| Overall change in patient-reported cough per EORTC QLQ-LC13 | Up to 5 years |
| Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13 | Up to 5 years |
| Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index | The EQ-5D-5L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale: no problems, slight problems, moderate problems, severe problems and extreme problems | Up to 5 years |
| Change in patient-reported general health status per Visual analogue scale (VAS) scores | The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". | Up to 5 years |
| Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30 | Up to 5 years |
| Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30 | Up to 5 years |
| Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30 | Up to 5 years |
| Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13 | Up to 5 years |
| Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13 | Up to 5 years |
| Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13 | Up to 5 years |
| Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13 | Up to 5 years |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Kansas Cancer Center-Westwood | Westwood | Kansas | 66205 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mercy South | St Louis | Missouri | 63128 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| Virginia Cancer Care Specialist, PC | Fairfax | Virginia | 22031 | United States |
| Eastern Health | Box Hill | Victoria | 3128 | Australia |
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| St John of God Murdoch Hospital | Murdoch | Western Australia | 6150 | Australia |
| Orlandi Oncologia | Providencia | Metropolitan Region | 7500713 | Chile |
| Clinica Santa Maria | Santiago | Providencia | 7520378 | Chile |
| Centro de Oncologia de Precision | Las Condes | Region Metropolitana, Santiago | 7560908 | Chile |
| Oncocentro APYS | Viña del Mar | Valparaiso | 2520598 | Chile |
| Centre de Oncologie de Gentilly | Nancy | Grand Est | 54000 | France |
| Institut de Cancerologie de l'Ouest | Saint-Herblain | Nantes | 44805 | France |
| Centre Hospitalier Universitaire (CHU) Bordeaux | Bordeaux | New Aquitaine | 33076 | France |
| CHU Limoges | Limoges | New Aquitaine | 87042 | France |
| APHP - Hopital Ambroise Pare | Boulogne-Billancourt | 92100 | France |
| CHU Dijon | Dijon | 21000 | France |
| Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec | Nantes | 44093 | France |
| Uneos - Hopital R Schuman | Vantoux | 57070 | France |
| Chi Creteil | Créteil | Île-de-France Region | 94010 | France |
| Hopital Cochin | Paris | Île-de-France Region | 75014 | France |
| Cancer Center of Adjara | Batumi | 6000 | Georgia |
| Israeli Georgian Medical Research Clinic Helsicore | Tbilisi | 0112 | Georgia |
| Llc Todua Clinic | Tbilisi | 0112 | Georgia |
| LTD New Hospitals | Tbilisi | 0114 | Georgia |
| High Technology Medical Center, University Clinic Tbilisi | Tbilisi | 0144 | Georgia |
| Institute of Clinical Oncology | Tbilisi | 0159 | Georgia |
| JSC K. Eristavi National Center of Experimental and Clinical Surgery | Tbilisi | 0159 | Georgia |
| TIM - Tbilisi Institute of Medicine | Tbilisi | 0160 | Georgia |
| Multiprofile Clinic Consilium Medulla | Tbilisi | 0186 | Georgia |
| LKI LUngenfachklinik Immenhausen | Immenhausen | Hesse | 34376 | Germany |
| Evang. Kliniken Essen-Mitte | Essen | North Rhine-Westphalia | 45136 | Germany |
| LungenClinic | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Universitatsklinium Giesse | Giessen | 35392 | Germany |
| Asklepios Klinikum Harburg | Hamburg | 21075 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH | Neuss | 41462 | Germany |
| Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale | Naples | Campania | 80131 | Italy |
| UOC Oncoematologia AOU Vanvitelli | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero-Universitaria Ferrara (AOU Ferrara) | Ferrara | Emilia-Romagna | 44124 | Italy |
| AUSL Piacenza | Piacenza | Emilia-Romagna | 29121 | Italy |
| Careggi University Hospital | Florence | Firenze | 50134 | Italy |
| UOC Oncologia Medica Ospedale Civile di Livorno Azienda Usl Toscana Nord Ovest | Livorno | Livorno | 57124 | Italy |
| ASST Ospedale Papa Giovanni XXIII | Bergamo | Lombardy | 24127 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Milano | 20122 | Italy |
| Azienda Sanitaria Territoriale di Pesaro e Urbino | Pesaro | Pesaro And Urbino | 61121 | Italy |
| Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo | Alessandria | Piedmont | 15121 | Italy |
| Centro di Riferimento Oncologico (CRO) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) | Aviano | Pordenone | 33081 | Italy |
| FPO- IRCCS, Istituto di Candiolo | Candiolo | Turin | 10060 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | Tuscany | 56124 | Italy |
| Istituto Tumori Giovanni Paolo II (Istituto di Ricovero e Cura a Carattere Scientifico Bari) | Bari | 70124 | Italy |
| ASST Cremona | Cremona | 26100 | Italy |
| Niguarda Cancer Center | Milan | 20162 | Italy |
| Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology | Novara | 28100 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico | Roma | 00128 | Italy |
| Instituto Fisioterapici Ospitalieri (IFO) Istituto Regina Elena | Rome | 00144 | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia | Udine | 33100 | Italy |
| Hospital Kuala Lumpur | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| University of Malaya Medical Centre | Kuala Lumpur | Negeri / Wilayah Persekutuan | 50603 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10990 | Malaysia |
| Hospital Umum Sarawak | Kuching | 93586 | Malaysia |
| National Cancer Center | Gyeonggi-do | Gyeonggi-do | 10408 | South Korea |
| The Catholic University of Korea St Vincents Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | 58128 | South Korea |
| Gachon University Gil Medical Center | Incheon | Namdong-Gu | 21565 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Korea University Guro Hospital | Seoul | 8308 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital General Universitario Elche | Elche | Alicante | 3203 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Andalusia | 18015 | Spain |
| Son Espases | Palma | Balearic Islands | 07120 | Spain |
| IOB Institute of Oncology Quiron | Barcelona | Catalonia | 08023 | Spain |
| Instituto Oncologico Dr Rosell | Barcelona | Catalonia | 08028 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Universitario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Alvaro Cunqueiro Hospital | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Althaia - Xarxa Assistencial Universitaria de Manresa - Orde Hospitalaria de Sant Joan de Deu | Barcelona | 8243 | Spain |
| Catalan Institute of Oncology | Girona | 17007 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28020 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital De Valme | Seville | 41001 | Spain |
| Fundacion IVO | Valencia | 46009 | Spain |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) | Valencia | 46026 | Spain |
| Changhua Christian Hospital | Changhua | Changhua County | 50006 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Sanmin | 807 | Taiwan |
| Hualien Tzu Chi Hospital | Hualien City | 97002 | Taiwan |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Chung Shan Medical University | Taichung | 40201 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110301 | Taiwan |
| Tri-Service General Hospital | Taipei | 114202 | Taiwan |
| Taipei Municipal Wan Fang Hospital | Taipei | 116 | Taiwan |
| Acibadem Adana Hastanesi | Adana | Adana | 1330 | Turkey (Türkiye) |
| Ege University Faculty of Medicine | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Kocaeli University Hospital | Kocaeli | Marmara | 41380 | Turkey (Türkiye) |
| Faculty of Medicine of Sakarya University | Sakarya | Marmara | 54290 | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Faculty of Medicine | Konya | Meram | 42080 | Turkey (Türkiye) |
| Ondokuz Mayıs University | Kurupelit | Samsun | 55139 | Turkey (Türkiye) |
| Medical Point Gaziantep Hastanesi | Gaziantep | Sehitkamil | 27584 | Turkey (Türkiye) |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital | Ankara | Yenimahalle | 06200 | Turkey (Türkiye) |
| Baskent University Adana Turgut Noyan Hospital | Adana | Yuregir | 01230 | Turkey (Türkiye) |
| Adana City Education and Research Hospital | Adana | Yuregir | 1060 | Turkey (Türkiye) |
| Gulhane Training and Research Hospital | Ankara | 06010 | Turkey (Türkiye) |
| Liv Hospital Ankara | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe University Cancer Institute | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hospital | Ankara | 0906520 | Turkey (Türkiye) |
| Ankara University Faculty of Medicine | Ankara | 6620 | Turkey (Türkiye) |
| Koc University | Istanbul | 34010 | Turkey (Türkiye) |
| Bezmialem Vakif University | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital | Istanbul | 34870 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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