臨床研究等提出・公開システム

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

Comparison between ABP 234 and Keytruda (Pembrolizumab)

Haby Henary

Amgen Inc.

4-1-3 Kyuutaromachi, Chuo-ku, Osaka, 541-0056, Japan

Japan-Chiken@iconplc.com

Clinical trial contact

ICON Clinical Research GK

4-1-3 Kyutaro-cho, Chuuou-ku, Osaka-city, Osaka, 541-0056, Japan

+81-6-4560-2001

Japan-Chiken@iconplc.com

Not Recruiting

June. 18, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

1. At least 18 years of age.
2. Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
3. Participant has no prior systemic treatment for advanced disease.
4. Measurable disease according to RECIST v1.1.
5. Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
6. Eastern Cooperative Oncology Group performance status score 0 or 1.
7. Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and c-ros oncogene 1, receptor tyrosine kinase of the insulin receptor family (ROS-1) negative
8. Have a life expectancy of at least 3 months.

1. Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
2. Participant has active central nervous system metastases not previously treated.
3. Participant has active or known immune-mediated disorders.
4. Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
5. Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.

Both

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

Drug: ABP 234*
Drug: Pembrolizumab (US)*
Drug: Pembrolizumab (EU)*
* Intravenous administration

- Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234
- AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234

+81-84-970-2121

April. 17, 2024

No

US/Argentina/Brazil/Bulgaria/Chile/France/Germany/Georgia/Austria/Italy/S Korea/Malaysia/Peru/Philippines/Poland/Romania/Serbia/Spain/Taiwan/Thailand/Turkey/the United Kingdom./South Africa