Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) (Eucalyptus)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: ABP 234; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06430866

20230127

Details and patient eligibility

About

The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

ABP 234

Experimental group

Description:

Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.

Treatment:

Drug: ABP 234

Pembrolizumab

Active Comparator group

Description:

Participants will receive pembrolizumab Q3W for up to 12 months.

Treatment:

Drug: Pembrolizumab