A Phase 3 interventional study of ABP 234 and Pembrolizumab (US) in Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer, sponsored by Amgen. Active, not recruiting at 218 sites in 23 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The primary objective of this trial is to demonstrate pharmacokinetic (PK) similarity of ABP 234 compared with the pembrolizumab reference product (Keytruda®).
Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: ABP 234
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.
Drug: Pembrolizumab (US)
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.
Drug: Pembrolizumab (EU)
Intravenous administration
Intravenous administration
Also known as: Keytruda®
Intravenous administration
Also known as: Keytruda®
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
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
OR
Time frame: Week 13
OR
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)
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
Showing the first 100 of 218 sites across 23 countries.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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