Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

Launched by AMGEN · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ABP 234 to see how it compares to an existing medication called Keytruda® (pembrolizumab) for patients with early-stage non-squamous non-small cell lung cancer (NSCLC) who have recently undergone surgery. The main goal is to demonstrate that ABP 234 works similarly to Keytruda in how it is processed in the body. The trial is currently recruiting participants aged 18 and older who have been diagnosed with specific stages of NSCLC, have received platinum-based chemotherapy after surgery, and have certain test results indicating they can safely join the study.

Eligible participants will undergo regular check-ups and treatments as part of the trial. It's important to note that those with active disease, certain medical conditions, or who have had specific prior treatments may not be able to participate. Participants will need to agree to use reliable birth control methods if they are of childbearing age. This study aims to provide more options for patients with lung cancer and help researchers learn more about ABP 234's effectiveness and safety.

Gender

ALL

Eligibility 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.