問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberR3767-ONC-2266
Active

2024-02-06 - 2029-08-30

Phase II

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 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

    2026/02/01

Investigators and Locations

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN 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

The Actual Total Number of Participants Enrolled

0 Recruiting

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 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 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 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 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 Division of Hematology & Oncology
Tri-Service General Hospital

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

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

injection

Active Ingredient

Fianlimab
cemiplimab

Dosage Form

270
270

Dosage

50mg/mL
75mg/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

A patient must meet the following criteria to be eligible for inclusion in the study:
2. 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).
3. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB
(N2) NSCLC as per AJCC version 8 (Amin, 2017). Pulmonary function capacity (eg, FVC,
FEV1, TLC, FRC, and DLco) sufficient to allow the proposed lung resection according to
the surgeon.
4. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node
sampling is required (either mediastinoscopy, thoracotomy, or EBUS).
5. 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.
6. ECOG PS 0 or 1
7. Adequate bone marrow function, as determined by hematological parameters:
a. 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
8. Adequate hepatic function, as determined by:
a. AST/ALT for adults: AST ≤3x ULN, ALT ≤3x ULN
b. Serum bilirubin ≤1.5x ULN, except in patients with clinically documented Gilbert's
Syndrome where ≤3x the ULN is permitted

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:
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 for 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 HIV, HBV or HCV infection; or diagnosis of
immunodeficiency that is related to, or results in chronic infection.
Notes:
a. Patients with known HIV who have controlled infection (undetectable viral load and
CD4 count above 350 either spontaneously or on a stable antiviral regimen) are
permitted. For patients with controlled HIV infection, monitoring will be performed
per local standards
b. Patients with known hepatitis B (HepB antigen+) who have controlled infection (serum
HBV DNA by PCR that is below the limit of detection AND receiving anti-viral
therapy for hepatitis B) are permitted. Patients with controlled infections must undergo
periodic monitoring of HBV DNA per local standards and must remain on anti-viral
therapy for at least 6 months beyond the last dose of investigational study drug
c. Patients who are known HCV antibody+ who have controlled infection (undetectable
HCV RNA by PCR either spontaneously or in response to a successful prior course of
anti-HCV therapy) are permitted.
Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious
disease or hepatologist) managing this disease prior to commencing and regularly
throughout the duration of their participation in the trial.
5. Pregnant or breastfeeding women.
6. Sexually active men and WOCBP who are unwilling to practice highly effective
contraception prior to the initial dose/start of the first treatment, during the study, and for
at least 6 months after the last dose. The duration of contraception after the last dose may
be increased (beyond 6 months), if applicable, based on the regimen of chemotherapy
administered and according to local prescribing information and practice guidelines.
Highly effective contraceptive measures include:
a. stable use of combined (estrogen and progestogen containing) hormonal contraception
(oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral,
injectable, implantable) associated with inhibition of ovulation initiated 2 or more
menstrual cycles prior to screening
b. IUD; IUS
c. bilateral tubal ligation (occlusion)
d. vasectomized partner (provided that the male vasectomized partner is the sole sexual
partner of the WOCBP study patient and that the vasectomized partner has obtained
medical assessment of surgical success for the procedure); and or
e. sexual abstinence†, ‡.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    180 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB