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Recruitment Complete
Sponsor ID
20210033

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants with Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Sponsor ID
20210033
Clinicaltrials.gov ID
NCT06311721
EUCTIS ID
N/A
EudraCT ID
2023-508336-57
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Study Details

The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).

Additional Study Details

Phase
Phase 3
Product
ABP 234
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
315
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234

Timeframe: 21 days

AUC21d of pembrolizumab (US)

Timeframe: 21 days

AUC21d of pembrolizumab (EU)

Timeframe: 21 days

AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234

Timeframe: Week 16 through Week 19

AUCtau_ss of pembrolizumab (US)

Timeframe: Week 16 through Week 19

AUCtau_ss of pembrolizumab (EU)

Timeframe: Week 16 through Week 19

Secondary Outcome Measures

Objective response (OR)

Timeframe: Week 49

OR

Timeframe: Week 13

OR

Timeframe: Week 31

Duration of response (DOR)

Timeframe: Up to 2.5 years

Progression-free survival (PFS)

Timeframe: Up to 2.5 years

Overall survival (OS)

Timeframe: Up to 2.5 years

Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234

Timeframe: Day 1 up to Week 107

Cmax_dose1 of pembrolizumab (US)

Timeframe: Day 1 up to Week 107

Cmax_dose1 of pembrolizumab (EU)

Timeframe: Day 1 up to Week 107

Time to maximum concentration following the first dose (tmax_dose1) of ABP 234

Timeframe: Day 1 up to Week 107

Tmax_dose1 of pembrolizumab (US)

Timeframe: Day 1 up to Week 107

Tmax_dose1 of pembrolizumab (EU)

Timeframe: Day 1 up to Week 107

Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234

Timeframe: Week 16 through Week 19

Cmax_ss of pembrolizumab (US)

Timeframe: Week 16 through Week 19

Cmax_ss of of pembrolizumab (EU)

Timeframe: Week 16 through Week 19

Time to maximum concentration at steady state (tmax_ss) of ABP 234

Timeframe: Week 16 through Week 19

Tmax_ss of pembrolizumab (US)

Timeframe: Week 16 through Week 19

Tmax_ss of pembrolizumab (EU)

Timeframe: Week 16 through Week 19

Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234

Timeframe: Week 4

Ctrough_w4 of pembrolizumab (US)

Timeframe: Week 4

Ctrough_w4 of pembrolizumab (EU)

Timeframe: Week 4

Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234

Timeframe: Week 16 through Week 19

Ctrough_ss at pre-dose of pembrolizumab (US)

Timeframe: Week 16 through Week 19

Ctrough_ss at pre-dose of pembrolizumab (EU)

Timeframe: Week 16 through Week 19

Number of participants who experience a Treatment-emergent adverse event

Timeframe: Up to 2.5 years

Number of participants who experience a Treatment-emergent serious adverse event

Timeframe: Up to 2.5 years

Number of participants who experience a Treatment-emergent adverse event of interest

Timeframe: Up to 2.5 years

Number of participants who experience anti-drug antibodies (ADA)

Timeframe: Up to 2.5 years

Locations

Location
Status
Contact Us
Location
Osaki Citizen Hospital
Osaki, Miyagi, Japan, 989-6183
Status
Recruiting
Location
Chugoku Central Hospital
Fukuyama city, Hiroshima, Japan, 720-0001
Status
Recruiting
Location
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki city, Hyogo, Japan, 660-8550
Status
Recruiting
Location
Kangbuk Samsung Hospital
Seoul, Seoul, Republic of Korea, 03181
Status
Recruiting
Location
Millennium Research and Clinical Development, LLC
Houston, Texas, United States, 77090
Status
Completed
Location
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Status
Terminated
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Study Info
Age
18 - 99 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Sep 2024 - Jan 2028
    Inclusion and Exclusion Criteria
    Inclusion 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.
    Exclusion 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.