A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC).

The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself.

The study is looking at several other research questions, including:

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: fianlimab; Drug: cemiplimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2113
      • Macquarie University Health Science Center (MQ Health)
    • Wagga Wagga, New South Wales, Australia, 2650
      • Riverina Cancer Care Centre (RCCC)
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Centre
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Regional Integrated Cancer Centre (BRICC)
    • Bendigo, Victoria, Australia, 3550
      • Bendigo Hospital
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • British Columbia Cancer Center-Kelowna
• Georgia
  • Tbilisi, Georgia, 0112
    • Research Institute of Clinical Medicine
  • Tbilisi, Georgia, 0112
    • Israeli Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia, 0160
    • TIM - Tbilisi Institute of Medicine
  • Tbilisi, Georgia, 0144
    • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
  • Tbilisi, Georgia, 0159
    • NNLE New Vision University Hospital
  • Tbilisi, Georgia, 0159
    • The Institute of Clinical Oncology
  • Tbilisi, Georgia, 0179
    • JSC Evex Hospitals - Caraps Medline
  • Adjara
    • Batumi, Adjara, Georgia, 6000
      • Cancer Center of Adjara
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
  • Tel Aviv, Israel, 6971028
    • Assuta Medical Centers
  • Southern District
    • Beersheba, Southern District, Israel, 84101
      • Soroka University Medical Center
• Malaysia
  • Pulau Pinang, Malaysia, 10990
    • Hospital Pulau Pinang
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Hospital Kuala Lumpur
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Hospital Tengku Ampuan Afzan (HTTA)
  • Putrajaya
    • Putrajaya, Putrajaya, Malaysia, 62250
      • National Cancer Institute
• South Korea
  • Daejeon, South Korea, 35015
    • Chungnam national university hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hospital
  • Gyeonggi-do
    • Incheon, Gyeonggi-do, South Korea, 21565
      • Gachon University Gil Medical Center
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
    • Suwon, Gyeonggi-do, South Korea, 16247
      • St. Vincents Hospital - The Catholic University of Korea
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Barcelona Hospital Campus
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Seville, Spain, 41001
    • Hospital De Valme
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clinico Universitario Santiago de Compostela
  • Balearic Islands
    • Palma, Balearic Islands, Spain, 07120
      • Son Espases
  • Catalonia
    • Barcelona, Catalonia, Spain, 08028
      • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Chung-Ho Memorial Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University - Shuang Ho Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taipei, Taiwan, 110301
    • Taipei Medical University Hospital
  • Chia-Yi
    • Dalin, Chia-Yi, Taiwan, 622
      • Dalin Tzu Chi Hospital
  • Hualien
    • Hualien City, Hualien, Taiwan, 970
      • Buddhist Tzu Chi General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University
  • Bangkok
    • Dusit, Bangkok, Thailand, 10300
      • Navamindradhiraj University
  • Changwat Lampang
    • Lampang, Changwat Lampang, Thailand, 52000
      • Lampang Cancer Center
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Prince Of Songkla Hospital, Prince Of Songkhla University
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1123
    • Baskent University
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06010
    • Ankara Etlik Sehir Hastanesi Ankara Etlik City Hospital
  • Ankara, Turkey (Türkiye), 06050
    • Ankara Yildirim Beyazit Universitesi - Tip Fakultesi
  • Ankara, Turkey (Türkiye), 06100
    • Gazi University
  • Ankara, Turkey (Türkiye), 06100
    • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
  • Ankara, Turkey (Türkiye), 06370
    • Yuksek Ihtisas Unıversity Medicalpark Hospital
  • Ankara, Turkey (Türkiye), 906520
    • Memorial Ankara Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Trakya University
  • Istanbul, Turkey (Türkiye), 34010
    • Koc University
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Vakif University
  • Istanbul, Turkey (Türkiye), 34450
    • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 81450
    • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
  • Istanbul, Turkey (Türkiye), 34180
    • Memorial Bahçelievler Hospital
  • Izmir, Turkey (Türkiye), 35110
    • Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Ve Arastirma Hastanesi
  • Izmir, Turkey (Türkiye), 35325
    • Izmir Economy University Medical Point Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Vm Medicalpark Hospital
  • Adana
    • Adana, Adana, Turkey (Türkiye), 1330
      • Acibadem Adana Hastanesi
  • Ankara
    • Altındağ, Ankara, Turkey (Türkiye), 06230
      • Hacettepe University Medical Faculty
  • Bagcilar
    • Istanbul, Bagcilar, Turkey (Türkiye), 34284
      • Medipol University Hospital
  • Gorukle Bursa Turkiye
    • Bursa, Gorukle Bursa Turkiye, Turkey (Türkiye), 16059
      • Bursa Uludag University Medical Faculty
  • Istanbul
    • Pendik, Istanbul, Turkey (Türkiye), 34899
      • Istinye University VMMedical Park Pendik Hospital
  • Marmara
    • Kocaeli, Marmara, Turkey (Türkiye), 41380
      • Kocaeli University Hospital
  • 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
      • Gaziantep Medicalpoint Hospital
  • Serdivan
    • Sakarya, Serdivan, Turkey (Türkiye), 54050
      • Sakarya University
  • Yuregir
    • Adana, Yuregir, Turkey (Türkiye), 1060
      • Adana City Education and Research Hospital
  • İzmir
    • Bornova, İzmir, Turkey (Türkiye), 35100
      • Ege University Faculty of Medicine
• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Arizona Clinical Research Center
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Medical Center
  • California
    • Redlands, California, United States, 92373
      • Emad Ibrahim, MD, Inc.
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern CT Hematology and Oncology Associates
  • Florida
    • Clermont, Florida, United States, 34711
      • Clermont Oncology Center
    • Miami, Florida, United States, 33125
      • Miami Veterans Administration HealthCare System
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology and Oncology Center
    • St. Petersburg, Florida, United States, 33709
      • Pinellas Hematology and Oncology
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial HealthCare
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Mercy South
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Healthcare
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Cancer Care Alliance
  • New York
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance Inc
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • El Paso, Texas, United States, 79915
      • Renovatio Clinical
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Midlothian, Virginia, United States, 23114
      • Bon Secours Cancer Institute Richmond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC.
2. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample, without intervening therapy between biopsy collection and screening as described in the protocol
3. For enrollment in phase 2, patients should have PD-L1 levels ≥ 50%, as determined by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accredited laboratory, as described in the protocol. For enrollment in phase 3, patients should have expression of programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cells stained using an assay performed by a central laboratory, as described in the protocol.
4. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
6. Adequate organ and bone marrow function, as described in the protocol.

Key Exclusion Criteria:

1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated, and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy.
3. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-ros oncogene 1 (ROS1) fusions, as described in the protocol.
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment.
6. Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome, T-cell-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency).
7. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization. Physiologic replacement doses are allowed even if they are >10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Patients with clinically relevant systemic immune suppression within the last 3 months before trial enrollment are excluded. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.

9. Patients who have received prior systemic therapies are excluded with the exception of the following:

   1. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery and/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy as long as toxicities have resolved to CTCAE grade ≤1 or baseline with the exception of alopecia and peripheral neuropathy.
   2. Anti-PD-(L) 1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as long as the last dose is >12 months prior to enrollment.
   3. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant or neoadjuvant therapy, Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibodies as long as the last dose is >6 months prior to enrollment. Immune-mediated AEs must be resolved to CTCAE grade ≤1 or baseline by the time of enrollment. Endocrine immune-mediated AEs controlled with hormonal or other non-immunosuppressive therapies without resolution prior to enrollment are allowed.

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: A: fianlimab+cemiplimab; Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)	Drug: fianlimab; Every three weeks (Q3W) as intravenous (IV) co-infusion; Other Names: REGN3767; Drug: cemiplimab; Q3W as IV co-infusion; Other Names: REGN2810; Libtayo
Experimental: B: fianlimab+cemiplimab; Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)	Drug: fianlimab; Every three weeks (Q3W) as intravenous (IV) co-infusion; Other Names: REGN3767; Drug: cemiplimab; Q3W as IV co-infusion; Other Names: REGN2810; Libtayo
Experimental: C: cemiplimab monotherapy+placebo; Phase 2 and Phase 3	Drug: cemiplimab; Q3W as IV co-infusion; Other Names: REGN2810; Libtayo; Drug: Placebo; Q3W as IV co-infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Phase 3 The time from randomization to the date of death due to any cause	Up to 5 years
Objective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)	Phase 2 Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)	Up to 136 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Phase 2 and Phase 3 A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment	Up to 136 weeks
Incidence of treatment-related TEAEs	Phase 2 and Phase 3	Up to 136 weeks
Incidence of serious adverse events (SAEs)	Phase 2 and Phase 3 Any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger); Is life-threatening; Requires in-patient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Is an important medical event	Up to 136 weeks
Incidence of adverse events of special interest (AESIs)	Phase 2 and Phase 3 Serious or non-serious; is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it.	Up to 136 weeks
Incidence of immune-mediated adverse events (imAEs)	Phase 2 and Phase 3 Immune-mediated AEs are thought to be caused by unrestrained cellular immune responses directed at normal host tissues. An imAE can occur shortly after the first dose or several months after the last dose of treatment. Early detection and management reduces the risk of severe drug induced toxicity	Up to 136 weeks
Occurrence of interruption of study drug(s) due to TEAEs	Phase 2 and Phase 3	Up to 136 weeks
Occurrence of discontinuation of study drug(s) due to TEAEs	Phase 2 and Phase 3	Up to 136 weeks
Occurrence of interruption of study drug(s) due to AESIs	Phase 2 and Phase 3	Up to 136 weeks
Occurrence of discontinuation of study drug(s) due to AESIs	Phase 2 and Phase 3	Up to 136 weeks
Occurrence of interruption of study drug(s) due to imAEs	Phase 2 and Phase 3	Up to 136 weeks
Occurrence of discontinuation of study drug(s) due to imAEs	Phase 2 and Phase 3 A unique set of toxicities thought to be caused by unrestrained cellular immune responses	Up to 136 weeks
Incidence of deaths due to TEAE	Phase 2 and Phase 3	Up to 136 weeks
Incidence of grade 3 to 4 laboratory abnormalities	Phase 2 and Phase 3 ≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]	Up to 136 weeks
ORR by investigator assessment, using RECIST 1.1	Phase 2	Up to 136 weeks
Disease control rate (DCR) by BICR	Phase 2 and Phase 3 The proportion of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD)	Up to 136 weeks
DCR by investigator assessment	Phase 2 and Phase 3	Up to 136 weeks
Time to tumor response (TTR) by BICR	Phase 2 and Phase 3 The time from randomization to the date of the first response of CR or PR (whichever is first recorded) for patients with confirmed CR or PR.	Up to 136 weeks
TTR by investigator assessment	Phase 2 and Phase 3	Up to 136 weeks
Duration of response (DOR) by BICR	Phase 2 and Phase 3 The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR.	Up to 5 years
DOR by investigator assessment	Phase 2 and Phase 3	Up to 5 years
Progression free survival (PFS) by BICR	Phase 2 and Phase 3	Up to 5 years
PFS by investigator assessment	Phase 2 and Phase 3	Up to 5 years
Overall survival (OS)	Phase 2 The time from randomization to the date of death due to any cause	Up to 5 years
Change from baseline in patient-reported physical functioning per EORTC QLQ-C30	Phase 2 and Phase 3	Up to 5 years
Change from baseline in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC13)	Phase 2 and Phase 3 EORTC QLQ-LC 13 is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients	Up to 5 years
Change from baseline in patient-reported dyspnea per EORTC QLQ-LC13	Phase 2 and Phase 3	Up to 5 years
Change from baseline in patient-reported cough per EORTC QLQ-LC13	Phase 2 and Phase 3	Up to 5 years
Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30	Phase 2 and Phase 3	Up to 5 years
Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30	Phase 2 and Phase 3	Up to 5 years
Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13	Phase 2 and Phase 3	Up to 5 years
Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13	Phase 2 and Phase 3	Up to 5 years
Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13	Phase 2 and Phase 3	Up to 5 years
Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13	Phase 2 and Phase 3	Up to 5 years
Change from baseline in patient-reported general health status per EuroQoL-5 Dimensions, 5-level Questionnaire-Visual Analogue Score (EQ-5D-5L VAS)	Phase 2 and Phase 3 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
Change from baseline in patient-reported severity with usual or daily activities due to fatigue per the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events (PRO-CTCAE).	Phase 2 and Phase 3 PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.	Up to 5 years
Change from baseline in patient-reported interference with usual or daily activities due to fatigue per the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events (PRO-CTCAE).	Phase 2 and Phase 3	Up to 5 years
Concentrations of cemiplimab in serum	Phase 2 and Phase 3	Up to 136 weeks
Concentrations of fianlimab in serum	Phase 2 and Phase 3	Up to 136 weeks
Immunogenicity, as measured by anti-drug antibodies (ADA) to fianlimab	Phase 2 and Phase 3	Up to 136 weeks
Immunogenicity, as measured by ADA to cemiplimab	Phase 2 and Phase 3	Up to 136 weeks
Immunogenicity, as measured by neutralizing antibodies (NAb) to fianlimab	Phase 2 and Phase 3	Up to 136 weeks
Immunogenicity, as measured by NAb to cemiplimab	Phase 2 and Phase 3	Up to 136 weeks
Change from baseline in patient-reported global health status/quality of life (GHS/QoL) per European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)	Phase 2 and Phase 3 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a 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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• NSCLC (Harmony Peri Op)

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): March 11, 2030
• Study Completion (Estimated): February 5, 2032

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Treatment naïve
• 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; Substandard Drugs; Pharmaceutical Preparations; cemiplimab
• Other Study ID Numbers: R3767-ONC-2235; 2022-501483-18-00 (Ctis: EUCT 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