Clinical trial NCT06161441: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Resectable Non-small Cell Lung Cancer
Keywords: Stage II to IIIB (N2)
NSCLC
Neoadjuvant therapy
Subsequent adjuvant therapy
PeriOperative
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples
timeFrame: Up to 24 months
Secondary outcomes:
measure: Event-Free Survival (EFS)
timeFrame: Up to 3 years
measure: Major pathological response (MPR) by BIPR in post-treatment resected tumor samples
timeFrame: Up to 24 months
measure: MPR by local pathology review in post-treatment resected tumor samples
timeFrame: Up to 24 months
measure: Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
timeFrame: Up to 24 months
measure: Occurrence of Adverse events (AEs)
timeFrame: Up to 5 years
measure: Occurrence of Treatment-emergent adverse event (TEAEs)
timeFrame: Up to 5 years
measure: Occurrence of Serious adverse events (SAEs)
timeFrame: Up to 5 years
measure: Occurrence of Adverse events of special interest (AESIs)
timeFrame: Up to 5 years
measure: Occurrence of immune-mediated adverse events (imAEs)
timeFrame: Up to 5 years
measure: Occurrence of interruption and discontinuation of study drug(s) due to TEAE
timeFrame: Up to 5 years
measure: Occurrence of laboratory abnormalities
timeFrame: Up to 5 years
measure: Occurrence of death due to TEAE
timeFrame: Up to 5 years
measure: Concentrations of cemiplimab in serum
timeFrame: Up to 30 months
measure: Concentrations of fianlimab in serum
timeFrame: Up to 30 months
measure: Anti-drug antibodies (ADA) to fianlimab in serum over time
timeFrame: Up to 30 months
measure: ADA to cemiplimab in serum over time
timeFrame: Up to 30 months
measure: Percentage of patients with definitive surgery
timeFrame: Up to 24 months
measure: Percentage of patients with cancelled surgery
timeFrame: Up to 24 months
measure: Percentage of patients with delayed surgery
timeFrame: Up to 24 months
measure: Completeness of resection (R0, R1, R2, Rx)
timeFrame: Up to 24 months
measure: Length in delay of surgery
timeFrame: Up to 24 months
measure: Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)
timeFrame: Up to 24 months
measure: Median length of hospital stay
timeFrame: Up to 24 months
measure: Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)
timeFrame: Up to 24 months
measure: Incidence of peri operative AE associated with surgery
timeFrame: Up to 90 days post-surgery
measure: Incidence of peri operative SAE associated with surgery
timeFrame: Up to 90 days post-surgery
measure: Incidence of post operative AE associated with surgery
timeFrame: Up to 90 days post-surgery
measure: Incidence of post operative SAE associated with surgery
timeFrame: Up to 90 days post-surgery
measure: 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)
timeFrame: Up to 5 years
measure: Overall change in patient-reported physical functioning per EORTC QLQ-C30
timeFrame: Up to 5 years
measure: Overall change in patient-reported role functioning per EORTC QLQ-C30
timeFrame: Up to 5 years
measure: 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)
timeFrame: Up to 5 years
measure: Overall change in patient-reported dyspnea per EORTC QLQ-LC13
timeFrame: Up to 5 years
measure: Overall change in patient-reported cough per EORTC QLQ-LC13
timeFrame: Up to 5 years
measure: Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13
timeFrame: Up to 5 years
measure: Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index
timeFrame: Up to 5 years
measure: Change in patient-reported general health status per Visual analogue scale (VAS) scores
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13
timeFrame: Up to 5 years
measure: Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Clermont
country: United States
facility: Clermont Oncology Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center-Westwood
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Mercy South
state: Missouri
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Fairfax
country: United States
facility: Virginia Cancer Care Specialist, PC
state: Virginia
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
state: Western Australia
city: Providencia
country: Chile
facility: Orlandi Oncologia
state: Metropolitan Region
city: Santiago
country: Chile
facility: Clinica Santa Maria
state: Providencia
city: Las Condes
country: Chile
facility: Centro de Oncologia de Precision
state: Region Metropolitana, Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro APYS
state: Valparaiso
city: Nancy
country: France
facility: Centre de Oncologie de Gentilly
state: Grand Est
city: Creteil
country: France
facility: Chi Creteil
state: Ile De France
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l'Ouest
state: Nantes
city: Metz
country: France
facility: Uneos - Hopital R Schuman
state: Vantoux
city: Tbilisi
country: Georgia
facility: Llc Todua Clinic
state: Caucasus
city: Batumi
country: Georgia
facility: Cancer Center of Adjara
city: Tbilisi
country: Georgia
facility: Israeli Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: LTD New Hospitals
city: Tbilisi
country: Georgia
facility: High Technology Medical Center, University Clinic Tbilisi
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology
city: Tbilisi
country: Georgia
facility: JSC K. Eristavi National Center of Experimental and Clinical Surgery
city: Tbilisi
country: Georgia
facility: TIM - Tbilisi Institute of Medicine
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consilium Medulla
city: Grosshansdorf
country: Germany
facility: LungenClinic
state: Schleswig-Holstein
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
state: Negeri / Wilayah Persekutuan
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
state: Pulau Pinang
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Cluj-Napoca
country: Romania
facility: Cardiomed
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Medisprof Cancer Center
state: Cluj
city: Timisoara
country: Romania
facility: Oncocenter Oncologie Clinica S.R.L
state: Timis
city: Timisoara
country: Romania
facility: Oncomed
state: Timis
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Girona
country: Spain
facility: Catalan Institute of Oncology
city: Valencia
country: Spain
facility: Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua County
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
state: Marmara
city: Sakarya
country: Turkey
facility: Faculty of Medicine of Sakarya University
state: Marmara
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Faculty of Medicine
state: Meram
city: Kurupelit
country: Turkey
facility: Ondokuz Mayıs University
state: Samsun
city: Adana
country: Turkey
facility: Acibadem Adana Hastanesi
state: Seyhan
city: Ankara
country: Turkey
facility: Gulhane Research And Training Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Cancer Institute
city: Gaziantep
country: Turkey
facility: Medical Point Gaziantep Hastanesi
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: