A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
Phase 3
Recruiting
- Conditions
- Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06311721
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 927
Inclusion Criteria
- At least 18 years of age.
- Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).
- Participant has no prior systemic treatment for advanced disease.
- Measurable disease according to RECIST v1.1.
- Tumor tissue from the resected site of disease must be available for biomarker analyses in order to be randomized.
- Eastern Cooperative Oncology Group performance status score 0 or 1.
- 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
- Have a life expectancy of at least 3 months.
Exclusion Criteria
- Small cell lung cancer (SCLC) or mixed SCLC/NSCLC histology or squamous cell carcinoma.
- Participant has active central nervous system metastases not previously treated.
- Participant has active or known immune-mediated disorders.
- Participant has received prior systemic cytotoxic chemotherapy, immunotherapy (including PD-1/PD-L1), anti-neoplastic biological therapy, or targeted therapy for advanced/metastatic disease.
- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug, or to any component of cisplatin, carboplatin, or pemetrexed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab (US) Pembrolizumab (US) Part 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed. ABP 234 ABP 234 Part 1: Participants will receive ABP 234 followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive ABP 234 followed by pemetrexed. Pembrolizumab (EU) Pembrolizumab (EU) Part 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.
- Primary Outcome Measures
Name Time Method Objective response (OR) Week 49 OR defined as an overall response of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Area under the serum concentration-time curve (AUC) from time 0 to 21 days (AUC21d) of ABP 234 21 days AUC at steady state between Week 16 and Week 19 (AUCtau_ss) of ABP 234 Week 16 through Week 19
- Secondary Outcome Measures
Name Time Method Tmax_ss of pembrolizumab (EU) Week 16 through Week 19 OR Week 31 Duration of response (DOR) Up to 2.5 years Maximum observed serum concentration following the first dose (Cmax_dose1) of ABP 234 Day 1 up to Week 107 Time to maximum concentration following the first dose (tmax_dose1) of ABP 234 Day 1 up to Week 107 Maximum observed serum concentration (Cmax) at steady state (Cmax_ss) of ABP 234 Week 16 through Week 19 Tmax_dose1 of pembrolizumab (US) Day 1 up to Week 107 Tmax_dose1 of pembrolizumab (EU) Day 1 up to Week 107 Cmax_ss of pembrolizumab (US) Week 16 through Week 19 Cmax_ss of of pembrolizumab (EU) Week 16 through Week 19 Tmax_ss of pembrolizumab (US) Week 16 through Week 19 Ctrough_w4 of pembrolizumab (US) Week 4 Ctrough_w4 of pembrolizumab (EU) Week 4 Trough serum concentrations at steady state (Ctrough_ss) at pre-dose of ABP 234 Week 16 through Week 19 Time to maximum concentration at steady state (tmax_ss) of ABP 234 Week 16 through Week 19 Trough serum concentrations at pre-dose of week 4 (Ctrough_w4) of ABP 234 Week 4 AUC21d of pembrolizumab (US) 21 days AUC21d of pembrolizumab (EU) 21 days Number of participants who experience anti-drug antibodies (ADA) Up to 2.5 years Ctrough_ss at pre-dose of pembrolizumab (US) Week 16 through Week 19 Ctrough_ss at pre-dose of pembrolizumab (EU) Week 16 through Week 19 AUCtau_ss of pembrolizumab (US) Week 16 through Week 19 AUCtau_ss pembrolizumab (EU) Week 16 through Week 19 Number of participants who experience a Treatment-emergent adverse event Up to 2.5 years Number of participants who experience a Treatment-emergent serious adverse event Up to 2.5 years Number of participants who experience a Treatment-emergent adverse event of interest Up to 2.5 years Overall survival (OS) Up to 2.5 years Progression-free survival (PFS) Up to 2.5 years Cmax_dose1 of pembrolizumab (US) Day 1 up to Week 107 Cmax_dose1 of pembrolizumab (EU) Day 1 up to Week 107
Trial Locations
- Locations (204)
Precision NextGen Oncology and Research Center
🇺🇸Beverly Hills, California, United States
TOI Clinical Research
🇺🇸Cerritos, California, United States
Cancer and Blood Specialty Clinic (CBSC)
🇺🇸Los Alamitos, California, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
PIH Health Hospital
🇺🇸Whittier, California, United States
Millennium Oncology - Hollywood
🇺🇸Hollywood, Florida, United States
BRCR Medical Center Inc.
🇺🇸Tamarac, Florida, United States
Accellacare Duly
🇺🇸Plainfield, Illinois, United States
McFarland Clinic
🇺🇸Ames, Iowa, United States
Detroit Clinical Research Center, PC
🇺🇸Farmington Hills, Michigan, United States
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