Clinical Trials List
2024-11-01 - 2027-04-30
Others
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
Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) versus Keytruda® in Combination with Chemotherapy for the Treatment of Patients with Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)
-
Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 林宗哲 無
- WEI-LI MA 無
- Chia-Chi Lin 無
- 黃得瑞 無
- 吳尚俊 無
- JIN-YUAN SHIH 無
- James Chih-Hsin Yang 無
- YEN-TING LIN 無
- 黃信端 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃怡菁 無
- 鍾秉軒 無
- Yu-Min Yeh 無
- Chien-Chung Lin 無
- 蔡政軒 無
- Shang-Yin Wu 無
- Seu-Chun Yang 無
- 黃怡璇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-HAN TSENG 無
- Yung-Hung Luo 無
- Chi-Lu Chiang 無
- 廖映庭 無
- 趙恒勝 無
- Hsu-ching Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Yen Tu 無
- Yu-Chao Lin 無
- Chia-Hsiang Li Division of General Internal Medicine
- 陳鴻仁 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊政皓 無
- Inn-Wen Chong 無
- 李玫萱 Division of Thoracic Medicine
- Chih-Jen Yang 無
- Ying-Ming Tsai Tsai 無
- 郭家佑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
prior to 1st dose of study drug (baseline) until 7 days after randomization.
NOTE: If the dosing duration is increased by the IDMC to up to 10 days, the AUC of RSV
RNA in patients assigned the longer dosing duration will be measured from baseline until
2 days after the last dose.
Inclution Criteria
2. Female subjects of non-childbearing potential (i.e., surgically sterilized, post-menopausal
[amenorrhea for 1 year confirmed by negative hormone panel]) who also have a negative
pregnancy test at screening.
3. Male subjects must be either surgically sterilized (e.g., post-vasectomy or orchiectomy) or
willing to adhere to the study’s contraceptive requirements (see Section 6.2.11). Male
subjects’ female partner(s) must be surgically sterilized or post-menopausal (amenorrhea for
1 year) or their female partner(s) of child-bearing potential must be willing and able to
adhere to the contraceptive requirements (see Section 6.2.11).
4. Each subject or their legal guardian must sign an informed consent form (ICF) indicating that
he or she understands the purpose of and procedures required for the study and is willing to
participate in the study before starting any screening activities.
5. Subject has a positive RT-PCR test result for RSV at the time of screening.
NOTE: Co-infection with other acute viruses or bacteria is permitted.
6. Subject has been, or will be, admitted to the hospital for an acute respiratory illness with
signs and symptoms consistent with a viral infection (e.g., fever, cough, nasal congestion,
runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset
<7 days from the anticipated time of randomization.
NOTE: The viral infection may present in any way so long as the underlying precipitant of
the illness is considered by the PI to be due to RSV infection. Examples of such an illness
include:
Exclusion Criteria
glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) <30 mL/min.
Cockcroft-Gault Formula
CCr = (140 – age) × Mass (kg) × (0.85 if female)
72 * Creatinine Clearance (mg/dL)
CCr = (140 – age) × Mass (kg) × K
Serum Creatinine (μmol/L)
Where K = 1.23 if male; 1.04 if female
NOTE: The independent data monitoring committee (IDMC) may lower the exclusionary
GFR limit to <15 mL/min if emerging PK data in subjects with GFR ≥30 mL/min suggest
that ALS-008112 and ALS-008144 exposures in the setting of severe (i.e., GFR
≥15-<30 mL/min renal impairment are projected to remain within an acceptable range.
2. Subject has presence of any concurrent illness, including laboratory, vital sign, ECG, or
physical exam findings, or medical history that, in the opinion of the investigator, would
place the subject at an unreasonably increased risk as a result of participation in this study.
3. Subject reports receiving an investigational drug or vaccine within 30 days, or 5 half-lives
(whichever is longer) prior to the planned first dose of study drug.
4. Subject has a known history of human immunodeficiency virus (HIV) or chronic, active
hepatitis infection.
5. ALT >3×ULN AND bilirubin >2×ULN (direct >35%) OR ALT>5×ULN
6. Subjects who have been hospitalized for >72 hours at the time of randomization.
7. Subjects anticipated to be hospitalized for <24 hours after randomization.
8. Subjects who are not expected to survive for <48 hours.
9. Recent (<5 half-lives) use, or anticipated use during conduct of the study, of concomitant
medications (prescription and non-prescription) which are inhibitors of the OAT3 transporter
(see Concomitant / Prohibited Medications, Section 5.10).
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
726 participants
