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Clinical Trials List

Protocol NumberR3767-ONC-2235
Active

2023-07-01 - 2030-06-30

Phase II

Recruiting8

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

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%

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Regeneron Pharmaceuticals, Inc

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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 Recruiting

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

Co-Principal Investigator

  • 王佐輔 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 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 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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 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 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NON- SMALL CELL LUNG CANCER (NSCLC)

Objectives

Primary Objective • To assess the objective response rate (ORR) per blinded independent central review (BICR) of combination of cemiplimab and fianlimab at both 1600 mg and 400 mg compared with cemiplimab monotherapy in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express programmed death cell ligand- 1 (PD-L1) in ≥50% of tumor cells.

Test Drug

injection

Active Ingredient

REGN3767
REGN2810

Dosage Form

270
270

Dosage

50mg/mL

Endpoints

The primary endpoint is:
• ORR as assessed by BICR, using RECIST 1.1, up to 136 weeks.
ORR is defined as proportion of patients with a best overall
response of confirmed complete response (CR) or partial response
(PR).

Inclution Criteria

A patient must meet the following criteria to be eligible for inclusion in the study:
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 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.
3. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor
tissue sample, without intervening therapy between biopsy collection and screening.
• Guidance on biopsy sites:
a. Archival or fresh biopsies are acceptable.
b. FFPE tissue block must be ≤6 months old; however, unstained slides of tumor
sample (archival or recent) must be ≤2 weeks from preparation. A minimum
of 10 slides, or equivalent block volume, is required for patients with EGFR,
ALK, and ROS1 local results available. A minimum of 19 slides, or
equivalent block volume, is required for patients without EGFR, ALK, or
ROS1 local results available.
c. The biopsy should be from a metastatic or recurrent site which has not
previously been irradiated. Bone biopsies are allowed provided that they are
not de-calcified.
i. Exception: the primary lung tumor can be used if it is still in place and
the other metastatic sites are either not accessible (brain) or the biopsy
would put the patient at risk.

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:
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 testing positive for actionable EGFR gene mutations, ALK gene
translocations, or ROS1 fusions. For enrollment in the phase 2 part of the study, genetic
alteration status, as determined by a CAP/CLIA (or equivalently licensed, according to
local regulations) accredited laboratory should be available prior to screening. If genetic
alteration status is not available prior to the time the patient provides informed consent,
genetic alteration status results will be obtained during screening in a central laboratory
designated by the sponsor.
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).

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    850 participants

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