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Comparing the effects of ABP 234 and Keytruda in lung cancer treatment

A Randomized, Double-blind Study to Compare the Pharmacokinetics Between ABP 234 and Keytruda® (Pembrolizumab) in Participants With Early-stage Non-squamous Non-small Cell Lung Cancer as Adjuvant Treatment Following Resection and Platinum-based Chemotherapy

Phase 3 Interventional Amgen · NCT06430866

This study is testing if a new lung cancer treatment called ABP 234 works similarly to Keytruda in adults who have had surgery and chemotherapy for early-stage non-small cell lung cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment154 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionschemotherapy, pembrolizumab
Locations109 sites (Sofia and 108 other locations)
Trial IDNCT06430866 on ClinicalTrials.gov

What this trial studies

This study aims to demonstrate the pharmacokinetic similarity between ABP 234 and pembrolizumab (Keytruda) in patients with early-stage non-squamous non-small cell lung cancer (NSCLC). Participants will be adults who have undergone surgical resection and received platinum-based chemotherapy. The study will assess how the body processes these two treatments to determine if they behave similarly in terms of absorption, distribution, metabolism, and excretion. The findings could help establish ABP 234 as a viable alternative to Keytruda for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of early-stage non-squamous NSCLC who have undergone surgical resection and received platinum-based chemotherapy.

Not a fit: Patients with severe comorbidities or those who have not received prior platinum-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more accessible treatment option for early-stage NSCLC.

How similar studies have performed: Other studies have shown promising results in comparing pharmacokinetic profiles of similar treatments, suggesting this approach may yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Males and females ≥ 18 years of age.
* Pathological diagnosis of non-squamous NSCLC.
* Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy.
* For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers.
* Treated with platinum-based chemotherapy:

  1. Chemotherapy must have begun within 12 weeks after the resection surgery.
  2. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized.
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative.
* Have adequate organ function as indicated by laboratory values.
* Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration.
* Participants must sign approved informed consent form (ICF).

Exclusion Criteria:

* Evidence of disease.
* Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting.
* History or presence of immune-mediated disorders.
* Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll.
* Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV).
* Medical conditions requiring systemic immunosuppression.
* History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc.
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis.
* Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
* Woman of childbearing potential who is pregnant or is breast feeding.
* Woman of childbearing potential who is not consenting to use highly effective methods of birth control.
* Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control.
* Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP).
* Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study.
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease.
* Live vaccine therapy within 4 weeks prior to IP administration.
* Participation in another investigational drug study within 30 days prior to IP administration.

Where this trial is running

Sofia and 108 other locations

+59 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Early-stage Non-squamous Non-small Cell Lung CancerNSCLCKeytrudaPembrolizumabABP 234
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.