Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

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 andreceived platinum-based chemotherapy.

• For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected siteof 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 nomore 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-1negative.

• Have adequate organ function as indicated by laboratory values.

• Absence of severe comorbidities that in the opinion of the investigator might hamperparticipation 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-L1/2modulating agents in adjuvant setting.

• History or presence of immune-mediated disorders.

• Participants with type 1 diabetes mellitus, residual hypothyroidism due toautoimmune thyroiditis only requiring hormone replacement, or skin disorders notrequiring systemic treatment are permitted to enroll.

• Participant has positive screen for human immunodeficiency virus (HIV), hepatitis Bsurface 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 skincarcinoma, papillary thyroid cancer treated with surgery, etc.

• Known clinically significant history of liver disease consistent with Child-PughClass B or C, including active viral or other hepatitis virus, current alcohol abuseor cirrhosis.

• Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exceptionof 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 effectivemethods of birth control.

• Man with a partner of childbearing potential who does not consent to use highlyeffective methods of birth control.

• Participant has known hypersensitivity to monoclonal antibodies or to any of theexcipients of the investigational product (IP).

• Active cardiac disease or history of cardiac dysfunction, that in the judgment ofthe investigator would place the participant at additional risk when participatingin the study.

• Has a history of (non-infectious) pneumonitis/interstitial lung disease thatrequired 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 IPadministration.