A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

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:

• What side effects may happen from taking the study drugs
• How much of each study drug is in the blood at different times
• Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
• How administering the study drugs might affect quality of life

Study Overview

• Status: Active, not recruiting
• Conditions: Resectable Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo; Drug: Fianlimab

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • St John of God Murdoch Hospital
• Chile
  • Metropolitan Region
    • Providencia, Metropolitan Region, Chile, 7500713
      • Orlandi Oncologia
  • Providencia
    • Santiago, Providencia, Chile, 7520378
      • Clinica Santa Maria
  • Region Metropolitana, Santiago
    • Las Condes, Region Metropolitana, Santiago, Chile, 7560908
      • Centro de Oncología de Precisión
  • Valparaiso
    • Viña del Mar, Valparaiso, Chile, 2520598
      • Oncocentro APYS
• France
  • Boulogne-Billancourt, France, 92100
    • APHP - Hopital Ambroise Pare
  • Dijon, France, 21000
    • CHU Dijon
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec
  • Vantoux, France, 57070
    • Uneos - Hopital R Schuman
  • Grand Est
    • Nancy, Grand Est, France, 54000
      • Centre de Oncologie de Gentilly
  • Nantes
    • Saint-Herblain, Nantes, France, 44805
      • Institut de Cancérologie de l'Ouest
  • New Aquitaine
    • Bordeaux, New Aquitaine, France, 33076
      • Centre Hospitalier Universitaire (CHU) Bordeaux
    • Limoges, New Aquitaine, France, 87042
      • CHU Limoges
  • Île-de-France Region
    • Créteil, Île-de-France Region, France, 94010
      • Chi Creteil
    • Paris, Île-de-France Region, France, 75014
      • Hopital Cochin
• Georgia
  • Batumi, Georgia, 6000
    • Cancer Center of Adjara
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla
  • Tbilisi, Georgia, 0159
    • JSC K. Eristavi National Center of Experimental and Clinical Surgery
  • Tbilisi, Georgia, 0114
    • LTD New Hospitals
  • Tbilisi, Georgia, 0159
    • Institute of Clinical Oncology
  • Tbilisi, Georgia, 0112
    • Llc Todua Clinic
  • Tbilisi, Georgia, 0112
    • Israeli Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 0160
    • TIM - Tbilisi Institute of Medicine
  • Tbilisi, Georgia, 0144
    • High Technology Medical Center, University Clinic Tbilisi
• Germany
  • Esslingen am Neckar, Germany, 73730
    • Klinikum Esslingen
  • Giessen, Germany, 35392
    • Universitatsklinium Giesse
  • Hamburg, Germany, 21075
    • Asklepios Klinikum Harburg
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Neuss, Germany, 41462
    • MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
  • Hesse
    • Immenhausen, Hesse, Germany, 34376
      • Lki Lungenfachklinik Immenhausen
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45136
      • Evang. Kliniken Essen-Mitte
  • Schleswig-Holstein
    • Großhansdorf, Schleswig-Holstein, Germany, 22927
      • LungenClinic
• Italy
  • Bari, Italy, 70124
    • Istituto Tumori Giovanni Paolo II (Istituto di Ricovero e Cura a Carattere Scientifico Bari)
  • Cremona, Italy, 26100
    • ASST Cremona
  • Milan, Italy, 20162
    • Niguarda Cancer Center
  • Novara, Italy, 28100
    • Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-medico
  • Rome, Italy, 00144
    • Instituto Fisioterapici Ospitalieri (IFO) Istituto Regina Elena
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia
  • Campania
    • Naples, Campania, Italy, 80131
      • UOC Oncoematologia AOU Vanvitelli
    • Naples, Campania, Italy, 80131
      • Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy, 44124
      • Azienda Ospedaliero-Universitaria Ferrara (AOU Ferrara)
    • Piacenza, Emilia-Romagna, Italy, 29121
      • AUSL Piacenza
  • Firenze
    • Florence, Firenze, Italy, 50134
      • Careggi University Hospital
  • Livorno
    • Livorno, Livorno, Italy, 57124
      • UOC Oncologia Medica Ospedale Civile di Livorno Azienda Usl Toscana Nord Ovest
  • Lombardy
    • Bergamo, Lombardy, Italy, 24127
      • ASST Ospedale Papa Giovanni XXIII
  • Milano
    • Milan, Milano, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Pesaro And Urbino
    • Pesaro, Pesaro And Urbino, Italy, 61121
      • Azienda Sanitaria Territoriale di Pesaro e Urbino
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico (CRO) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
  • Turin
    • Candiolo, Turin, Italy, 10060
      • FPO- IRCCS, Istituto di Candiolo
  • Tuscany
    • Pisa, Tuscany, Italy, 56124
      • Azienda Ospedaliera Universitaria Pisana
• Malaysia
  • Kuching, Malaysia, 93586
    • Hospital Umum Sarawak
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur
  • Negeri / Wilayah Persekutuan
    • Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia, 50603
      • University of Malaya Medical Centre
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10990
      • Hospital Pulau Pinang
• South Korea
  • Incheon, South Korea, 22332
    • Inha University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 8308
    • Korea University Guro Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hospital
  • Gyeonggi-do
    • Gyeonggi-do, Gyeonggi-do, South Korea, 10408
      • National Cancer Center
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
    • Suwon, Gyeonggi-do, South Korea, 16247
      • The Catholic University of Korea St Vincents Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, South Korea, 58128
      • Chonnam National University Hwasun Hospital
  • Namdong-Gu
    • Incheon, Namdong-Gu, South Korea, 21565
      • Gachon University Gil Medical Center
• Spain
  • Barcelona, Spain, 8243
    • Althaia - Xarxa Assistencial Universitaria de Manresa - Orde Hospitalaria de Sant Joan de Deu
  • Girona, Spain, 17007
    • Catalan Institute of Oncology
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28020
    • Fundacion Jimenez Diaz
  • Seville, Spain, 41001
    • Hospital De Valme
  • Valencia, Spain, 46009
    • Fundacion IVO
  • Valencia, Spain, 46026
    • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clinico Universitario Santiago de Compostela
  • Alicante
    • Elche, Alicante, Spain, 3203
      • Hospital General Universitario Elche
  • Andalusia
    • Granada, Andalusia, Spain, 18015
      • Hospital Universitario Virgen de Las Nieves
  • Balearic Islands
    • Palma, Balearic Islands, Spain, 07120
      • Son Espases
  • Catalonia
    • Barcelona, Catalonia, Spain, 08023
      • IOB Institute of Oncology Quiron
    • Barcelona, Catalonia, Spain, 08028
      • Instituto Oncologico Dr Rosell
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Hospital Universitario Virgen de la Arrixaca
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Hospital Universitario de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Álvaro Cunqueiro Hospital
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
• Taiwan
  • Hualien City, Taiwan, 97002
    • Hualien Tzu Chi Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 114202
    • Tri-Service General Hospital
  • Taipei, Taiwan, 110301
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 116
    • Taipei Municipal Wan Fang Hospital
  • Changhua County
    • Changhua, Changhua County, Taiwan, 50006
      • Changhua Christian Hospital
  • Sanmin
    • Kaohsiung City, Sanmin, Taiwan, 807
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 0906520
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Cancer Institute
  • Ankara, Turkey (Türkiye), 6620
    • Ankara University Faculty of Medicine
  • Istanbul, Turkey (Türkiye), 34010
    • Koc University
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Vakif University
  • Istanbul, Turkey (Türkiye), 34870
    • Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital
  • Adana
    • Adana, Adana, Turkey (Türkiye), 1330
      • Acibadem Adana Hastanesi
  • Marmara
    • Kocaeli, Marmara, Turkey (Türkiye), 41380
      • Kocaeli University Hospital
    • Sakarya, Marmara, Turkey (Türkiye), 54290
      • Faculty of Medicine of Sakarya University
  • Meram
    • Konya, Meram, Turkey (Türkiye), 42080
      • Necmettin Erbakan University Meram Faculty of Medicine
  • Samsun
    • Kurupelit, Samsun, Turkey (Türkiye), 55139
      • Ondokuz Mayıs University
  • Sehitkamil
    • Gaziantep, Sehitkamil, Turkey (Türkiye), 27584
      • Medical Point Gaziantep Hastanesi
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06200
      • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Yuregir
    • Adana, Yuregir, Turkey (Türkiye), 01230
      • Baskent University Adana Turgut Noyan Hospital
    • Adana, Yuregir, Turkey (Türkiye), 1060
      • Adana City Education and Research Hospital
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Ege University Faculty of Medicine
• United States
  • Florida
    • Clermont, Florida, United States, 34711
      • Clermont Oncology Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center-Westwood
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Mercy South
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Northwest
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Care Specialist, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
3. All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate bone marrow, hepatic and kidney function as defined in the protocol

Key Exclusion Criteria:

1. Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
4. Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
5. Patients with a history of myocarditis

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab	Drug: Cemiplimab; Administered IV Q3W; Other Names: REGN2810; Libtayo; Drug: Pemetrexed; Administered IV Q3W; Other Names: Alimta; Drug: Paclitaxel; Administered IV Q3W; Other Names: Taxol; Drug: Carboplatin; Administered IV Q3W; Other Names: Paraplatin; Drug: Cisplatin; Administered IV Q3W; Other Names: Platinol; Drug: Placebo; Administered IV Q3W
Experimental: Arm B; Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab	Drug: Cemiplimab; Administered IV Q3W; Other Names: REGN2810; Libtayo; Drug: Pemetrexed; Administered IV Q3W; Other Names: Alimta; Drug: Paclitaxel; Administered IV Q3W; Other Names: Taxol; Drug: Carboplatin; Administered IV Q3W; Other Names: Paraplatin; Drug: Cisplatin; Administered IV Q3W; Other Names: Platinol; Drug: Fianlimab; Administered intravenously (IV) every 3 weeks (Q3W); Other Names: REGN3767
Experimental: Arm C; Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab	Drug: Cemiplimab; Administered IV Q3W; Other Names: REGN2810; Libtayo; Drug: Pemetrexed; Administered IV Q3W; Other Names: Alimta; Drug: Paclitaxel; Administered IV Q3W; Other Names: Taxol; Drug: Carboplatin; Administered IV Q3W; Other Names: Paraplatin; Drug: Cisplatin; Administered IV Q3W; Other Names: Platinol; Drug: Fianlimab; Administered intravenously (IV) every 3 weeks (Q3W); Other Names: REGN3767

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples	Up to 24 months

Secondary Outcome Measures

Outcome Measure	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		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
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
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): April 20, 2026
• Study Completion (Estimated): November 4, 2029

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Neoadjuvant therapy; Stage II to IIIB (N2); Subsequent adjuvant therapy; PeriOperative
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; cemiplimab
• Other Study ID Numbers: R3767-ONC-2266; 2023-505172-29-00 (Ctis: EU CTR Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy.

• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No