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Protocol NumberR3767-ONC-2236
Active

2023-06-01 - 2030-05-31

Phase III

Recruiting9

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 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 Chien-Chung Lin 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 無
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

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 賴學緯 無
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 Te-Chun Hsia 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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 Recruiting

Principal Investigator 林智斌 無
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 邱紹華
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

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

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.

The Estimated Number of Participants

  • Taiwan

    17 participants

  • Global

    950 participants

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