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Clinical Trials List

Protocol Number20210033
Active

2024-05-01 - 2029-03-31

Phase III

Not yet recruiting10

Recruiting1

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 Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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

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 Not yet recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet 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 Not yet recruiting

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 Not yet recruiting

Principal Investigator JIN-YUAN SHIH Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet 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 Not yet recruiting

Principal Investigator kang-Yun LEE
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

Objectives

Primary Objectives: • Compare the efficacy of ABP 234 with the reference drug pembrolizumab • Demonstrate the pharmacokinetic similarity of ABP 234 compared to the reference drug pembrolizumab Secondary Objectives: • Compare the efficacy of ABP 234 with the reference drug pembrolizumab • Compare the pharmacokinetic (PK) of ABP 234 with the reference drug pembrolizumab • Compare the PK of FDA-approved pembrolizumab with EU-approved pembrolizumab • Compare the safety of ABP 234 with the reference drug pembrolizumab • Compare the immunogenicity of ABP 234 with the reference drug pembrolizumab

Test Drug

injection
injection

Active Ingredient

ABP234
Pembrolizumab

Dosage Form

270
270

Dosage

25 MG/ML
100 mg/vial

Endpoints

• Objective treatment response (OR) up to week 49

• Area under the serum concentration-time curve from 0:00 after the first dose to day 21 (AUC21d); and

• AUC at steady state between weeks 16 and 19 (AUCtau_ss)

Inclution Criteria

1. Males and females aged ≥18 years at screening.

2. Stage IV non-squamous NSCLC, histologically or cytologically confirmed according to the American Joint Committee on Cancer (AJCC) 7th edition staging system.

3. No prior systemic therapy for advanced or metastatic disease; subjects who have previously received adjuvant or preoperative adjuvant therapy are eligible to participate if their treatment was completed at least 12 months prior to randomization. Subjects who have previously received palliative radiation therapy for symptom management are eligible to participate if their treatment was completed at least 3 weeks prior to randomization.

4. Disease measurable according to the RECIST v1.1 criteria for evaluating response to solid tumors.

5. For PD-L1 testing, tumor tissue from the disease resection site must be submitted and received and analyzed for biomarkers by a certified central laboratory before randomization can be performed. The most recently sealed specimen will be used (regardless of the specimen's storage time). If suitable stock tissue is unavailable, tissue sections may be performed.

6. East Coast Cancer Clinical Research Partnership (ECOG) Performance Status Score: 0 or 1.

7. Negative for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and proto-oncogene tyrosine kinase ROS (ROS-1) (if mutation status is unknown, EGFR, ALK, and ROS-1 testing can be performed by a certified central laboratory).

8. Life expectancy of at least 3 months.

9. Adequate organ function is indicated by the following laboratory test values:

a. Hematology:

i. Absolute neutrophil count (ANC) ≥ 1500/µL

ii. Platelets ≥ 100,000/µL

iii. Heme ≥ 9.0 g/dL or ≥ 5.6 mmol/L – no transfusion within the previous 4 weeks

b. Renal function:

i. Creatinine clearance (CrCl) calculated according to the Cockcroft-Gault formula ≥ 45 mL/min:

- Male subjects: CrCl (mL/min) = weight (kg) × (140 – age) / (72 × serum creatinine [mg/dL])

- Female subjects: CrCl (mL/min) = weight (kg) × (140 – age) / (72 × serum creatinine [mg/dL]) × 0.85

c. Liver Functions

i. Total serum bilirubin (TBL) ≤ 1.5 × Upper Limit of Normal (ULN); unless Gilbert's syndrome is present (total bilirubin to direct bilirubin ratio > 5), in which case TBL ≤ 3.0 × ULN is permissible, or direct bilirubin ≤ ULN for subjects with TBL concentration > 1.5 × ULN.

ii. Aspartate transaminase/serum glutamate-oxaloacetate transaminase (AST/SGOT) and alanine transaminase/serum glutamate-pyruvate transaminase (ALT/SGPT) ≤ 2.5 × ULN, or for subjects with liver metastases, ≤ 5 × ULN.

d. Coagulation

i. International Normalized Ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) ≤ 1.5 × ULN, unless the participant is receiving anticoagulant therapy, in which case PT or aPTT is acceptable as long as it falls within the therapeutic range intended for the anticoagulant's purpose.

10. Before any trial-specific procedures are performed, the participant must sign a Subject Consent Form (ICF) approved by the Human Trials Board (IRB)/Independent Ethics Committee (IEC).

Exclusion Criteria

1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histologically, or squamous cell carcinoma.

2. Known active central nervous system metastases and/or carcinomatous meningitis. Subjects previously treated for brain metastases are eligible for the trial, provided they have been clinically stable for at least 2 weeks, have no new or growing signs of brain metastases, and have completed any corticosteroid therapy at least 3 days prior to starting the investigational drug. If a stable or downgraded corticosteroid is used, it must be equivalent to ≤ 10 mg of prednisone daily. Stable brain metastases meeting this definition should be established before the first dose of the investigational drug.

3. Receiving > 30 Gy of lung radiation therapy within 6 months prior to the first dose of the investigational drug.

4. Having a history of or currently having an immune-mediated disorder. Subjects with type 1 diabetes, autoimmune thyroiditis resulting in residual hypothyroidism requiring only hormone replacement therapy, or skin conditions (e.g., vitiligo, psoriasis, or alopecia) that do not require systemic treatment are eligible for inclusion.

5. The subject has previously received systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), antitumor biologic therapy, or targeted therapy for advanced/metastatic disease.

6. A medical condition requiring systemic immunosuppression.

7. A history of any malignancy other than NSCLC within the past 5 years, with exceptions including cervical carcinoma in situ that has received appropriate treatment, non-melanoma skin cancer, and papillary thyroid cancer that has undergone surgical treatment.

8. A known history of clinically significant liver disease reaching Child-Pugh B or C, including active viral or other hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, or cirrhosis.

9. The subject has a positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or HCV screening.

Subjects with a known diagnosis of HIV infection are eligible for inclusion if they meet the following criteria:

a. Cluster 4 receptor (CD4+) T cell count > 350 cells/µL, and no opportunistic infection defining acquired immunodeficiency syndrome within the past 12 months.

b. Received antiretroviral therapy for more than 4 weeks prior to enrollment, with a viral load below 400 copies/µL.

Definition of active viral hepatitis:

• Active viral hepatitis infection is clinically defined as requiring antiretroviral therapy or a positive hepatitis B test result (HBsAg and/or total HBcAb, or HCV antibody).

• Subjects with a positive total HBcAb test are eligible if their HBsAg test and polymerase chain reaction (PCR) and HBV DNA test are negative.

• Subjects who have recovered from HCV infection (with undetectable viral load, i.e., a sustained virological response for 3 months after completion of treatment) are eligible for inclusion. Subjects who test positive for HCV antibodies are eligible if their HCV RNA test is negative. Subjects who are HCV carriers and test positive for HCV RNA are ineligible.

• For subjects who have been successfully treated for viral hepatitis, the trial administrator should consider the possibility of viral reactivation or reinfection with viral hepatitis and should determine that the overall potential benefit of the trial treatment for the subject outweighs the overall risk.

10. Pregnant or breastfeeding women of childbearing age.

11. Women of childbearing potential who do not agree to use highly effective contraception (e.g., complete abstinence, sterilization, birth control pills, long-acting injections, or implantable contraceptives) during the following treatment periods:

a. Four months after the last dose of an experimental drug (IP) (ABP 234 or pembrolizumab)

b. Six months after the last dose of carboplatin

c. Fourteen months after the last dose of cisplatin

d. Six months after the last dose of pemetrexed

12. Men whose partners are of childbearing potential and who do not agree to use highly effective contraception (e.g., complete abstinence, vasectomy, or condoms combined with female-specific hormonal or barrier methods) during the following treatment periods:

a. Four months after the last dose of IP (ABP 234 or pembrolizumab)

b. Carboplatin 13. Subjects have a known allergy to any excipient of the monoclonal antibody or investigational drug, or to any component of cisplatin, carboplatin, or pemetrexed.

14. A history of active heart disease or cardiac dysfunction that, in the assessment of the trial administrator, would place the subject at additional risk during participation in the trial.

15. A history of non-infectious pneumonia/interstitial lung disease requiring steroids, or currently having non-infectious pneumonia/interstitial lung disease.

16. Received a live vaccine within 4 weeks prior to administration of the investigational drug.

17. Participated in another investigational drug trial within 30 days prior to IP administration.

18. Subjects have a history of congenital immunodeficiency disease, or have previously undergone allogeneic stem cell transplantation or organ transplantation. 19. Received systemic long-term corticosteroid therapy (≥ 10 mg prednisone or equivalent daily) or any immunosuppressive therapy within 3 days prior to the first dose of trial treatment. Topical, inhaled, nasal, and ophthalmic steroids are permitted, as well as those used as a precondition for anaphylactic reactions (e.g., before CT scans).

20. Had an active, clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy within 30 days prior to the first dose of trial treatment. Prophylactic anti-infective therapy following local guidelines is permitted.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    927 participants

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