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Protocol NumberR3767-ONC-2266
Active

2024-02-06 - 2029-08-30

Phase II

Not yet recruiting8

Recruiting1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Regeneron Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/10/31

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Hematology & Oncology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Lun Chang Division of Hematology & Oncology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 賴學緯 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林智斌 Division of Thoracic Medicine
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC

Objectives

To assess pathological complete response (pCR) by blinded independent pathological review (BIPR) of fianlimab plus cemiplimab plus chemotherapy and cemiplimab plus chemotherapy in patients with resectable stage II to IIIB (N2) NSCLC.

Test Drug

REGN3767 (Fianlimab) REGN2810 (Cemiplimab)

Active Ingredient

Fianlimab
Cemiplimab

Dosage Form

injection

Dosage

50mg/mL
50mg/mL

Endpoints

Pathological complete response is defined as 0% residual viable tumor cells
in the lung and lymph nodes as evaluated by BIPR in post-treatment resected
tumor samples.

Inclution Criteria

1. Men and women ≥18 years of age (or the legal age of adults to
consent to participate in a clinical study per country-specific
regulations).
2. Patients with newly diagnosed, histologically confirmed, fully
resectable stage II to IIIB (N2) NSCLC as per AJCC version 8
(Amin, 2017), and pulmonary function capacity (eg, FVC, FEV1,
TLC, FRC, and DLco) sufficient to allow the proposed lung
resection according to the surgeon.
3. For patients with evidence of mediastinal adenopathy on imaging,
mediastinal lymph node sampling is required (either
mediastinoscopy, thoracotomy, or endobronchial ultrasound
[EBUS]).
4. The patient must have an evaluable tissue sample for biomarker
testing. Archival or fresh biopsy will be accepted. Blocks or slides
will be accepted. Blocks should be no more than 6 months old and
cut slides should be shipped for testing no later than 2 weeks from
the time of preparation. The minimum slide requirement is 10
slides. Cytology specimens and fine needle aspirates are not
acceptable. Please refer to lab manual for complete guidance on
tissue submission.
5. Eastern Cooperative Oncology Group (ECOG) performance status
(PS) 0 or 1
6. Adequate bone marrow function, as determined by hematological
parameters:
a. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
(1500/mm3)
b. Hemoglobin ≥9.0 g/dL (5.59 mmol/L).
c. Platelet count ≥75,000/mm³
7. Adequate hepatic function, as determined by:
a. AST/ALT for adults: aspartate aminotransferase (AST)
≤3x upper limit of normal (ULN), alanine
aminotransferase (ALT) ≤3x ULN

Exclusion Criteria

Key Exclusion:
1. Patients showing evidence of any distant metastases. Imaging at
baseline must include: brain MRI or CT (brain CT with contrast
allowable if MRI is contraindicated); a contrast-enhanced CT
scan of the chest, abdomen, pelvis and all known sites of disease
as clinically indicated. These imaging tests should be performed
within 28 days prior to randomization.
2. Patients with tumors with known actionable EGFR gene mutations,
ALK gene translocations (central testing for EGFR and ALK
aberrations will not be performed; local testing of EGFR and ALK
may be performed according to local requirements; unknown status
is not exclusionary).
3. Ongoing or recent (within 2 years) evidence of clinically
significant autoimmune disease that required systemic treatment
with immunosuppressive agents. The following are -non-
exclusionary: vitiligo, residual hypothyroidism that requires only
hormone replacement, psoriasis not requiring systemic treatment.
Additionally, use of systemic treatment with immunosuppressive
agents for childhood asthma, that has resolved, is considered non-
exclusionary.
4. Uncontrolled infection with human immunodeficiency virus
(HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or
diagnosis of immunodeficiency that is related to, or results in
chronic infection.

The Estimated Number of Participants

  • Taiwan

    8 participants

  • Global

    180 participants

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