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Clinical Trials List

Protocol Number20230127
NCT Number(ClinicalTrials.gov Identfier)NCT06430866
Active

2024-04-01 - 2027-05-31

Phase III

Recruiting6

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 Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

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 CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General 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 Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

Objectives

Primary Objective • Demonstrate the pharmacokinetic similarity between ABP 234 and pembrolizumab Secondary Objectives • Compare the pharmacokinetics of ABP 234 and pembrolizumab • Compare the safety profiles of ABP 234 and pembrolizumab • Compare the immunogenicity of ABP 234 and pembrolizumab • Compare the efficacy of ABP 234 and pembrolizumab

Test Drug

注射劑
注射劑

Active Ingredient

ABP 234
Pembrolizumab

Dosage Form

270
270

Dosage

25 mg/ml

Endpoints

Key pharmacokinetic endpoints:

• Area under the serum concentration-time curve (AUC21d) from time 0 after the first dose to day 21; and

• AUC between weeks 16 and 19 (AUCtau_ss)

Inclution Criteria

Inclusion Criteria:

Males and females ≥ 18 years of age.
Pathological diagnosis of non-squamous NSCLC.
Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy.
For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers.
Treated with platinum-based chemotherapy:

Chemotherapy must have begun within 12 weeks after the resection surgery.
The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.
Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative.
Have adequate organ function as indicated by laboratory values.
Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration.
Participants must sign approved informed consent form (ICF).

Exclusion Criteria

Exclusion Criteria:

Evidence of disease.
Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting.
History or presence of immune-mediated disorders.
Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll.
Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV).
Medical conditions requiring systemic immunosuppression.
History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc.
Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis.
Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
Woman of childbearing potential who is pregnant or is breast feeding.
Woman of childbearing potential who is not consenting to use highly effective methods of birth control.
Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control.
Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP).
Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study.
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease.
Live vaccine therapy within 4 weeks prior to IP administration.
Participation in another investigational drug study within 30 days prior to IP administration.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    154 participants

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