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

Phase 3Active Not RecruitingNCT06311721

Amgen315 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

315

Conditions

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

Interventions

ABP 234DRUG

Intravenous administration

Pembrolizumab (US)DRUG

Intravenous administration

Pembrolizumab (EU)DRUG

Intravenous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (218)

Outcomes

Primary Outcomes

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

Time frame: 21 days

AUC21d of pembrolizumab (US)

Time frame: 21 days

AUC21d of pembrolizumab (EU)

Time frame: 21 days

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

Time frame: Week 16 through Week 19

AUCtau_ss of pembrolizumab (US)

Time frame: Week 16 through Week 19

AUCtau_ss of pembrolizumab (EU)

Time frame: Week 16 through Week 19

Secondary Outcomes

Objective response (OR)

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.

Time frame: Week 49

Time frame: Week 13

Time frame: Week 31

Duration of response (DOR)

Time frame: Up to 2.5 years

Progression-free survival (PFS)

Time frame: Up to 2.5 years

Overall survival (OS)

Data from ClinicalTrials.gov

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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

Accellacare of McFarland

Ames, Iowa, United States

Detroit Clinical Research Center, PC

Farmington Hills, Michigan, United States

...and 208 more locations

Time frame: Up to 2.5 years

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

Time frame: Day 1 up to Week 107

Cmax_dose1 of pembrolizumab (US)

Time frame: Day 1 up to Week 107

Cmax_dose1 of pembrolizumab (EU)

Time frame: Day 1 up to Week 107

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

Time frame: Day 1 up to Week 107

Tmax_dose1 of pembrolizumab (US)

Time frame: Day 1 up to Week 107

Tmax_dose1 of pembrolizumab (EU)

Time frame: Day 1 up to Week 107

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

Time frame: Week 16 through Week 19

Cmax_ss of pembrolizumab (US)

Time frame: Week 16 through Week 19

Cmax_ss of of pembrolizumab (EU)

Time frame: Week 16 through Week 19

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

Time frame: Week 16 through Week 19

Tmax_ss of pembrolizumab (US)

Time frame: Week 16 through Week 19

Tmax_ss of pembrolizumab (EU)

Time frame: Week 16 through Week 19

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

Time frame: Week 4

Ctrough_w4 of pembrolizumab (US)

Time frame: Week 4

Ctrough_w4 of pembrolizumab (EU)

Time frame: Week 4

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

Time frame: Week 16 through Week 19

Ctrough_ss at pre-dose of pembrolizumab (US)

Time frame: Week 16 through Week 19

Ctrough_ss at pre-dose of pembrolizumab (EU)

Time frame: Week 16 through Week 19

Number of participants who experience a Treatment-emergent adverse event

Time frame: Up to 2.5 years

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

Time frame: Up to 2.5 years

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

Time frame: Up to 2.5 years

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

Time frame: Up to 2.5 years