Comparison between ABP 234 and Keytruda (Pembrolizumab)

JRCT ID: jRCT2061240025

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
• Date of first enrollment: 09/09/2024
• Target sample size: 40
• Countries of recruitment: US,Japan,Argentina,Japan,Brazil,Japan,Bulgaria,Japan,Chile,Japan,France,Japan,Germany,Japan,Georgia,Japan,Austria,Japan,Italy,Japan,S Korea,Japan,Mexico,Japan,Malaysia,Japan,Peru,Japan,Philippines,Japan,Poland,Japan,Romania,Japan,Serbia,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,the United Kingdom.,Japan,South Africa,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

- Objective response (OR)
- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 99age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Haby Henary