Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
NSCLC, Keytruda, Pembrolizumab, ABP 234
Brief summary
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
Interventions
DRUGABP 234
Administered by intravenous (IV) injection.
DRUGPembrolizumab
Administered by IV injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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). * History of congenital immunodeficiency diseases, prior allogeneic stem cell transplantation, or organ transplantation. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose | 21 days |
| AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss) | Weeks 16-19 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1) | Up to 65 weeks |
| Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1) | Up to 65 weeks |
| Cmax at Steady State (Cmax_ss) | Weeks 16-19 |
| Tmax at Steady State (Tmax_ss) | Weeks 16-19 |
| Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4) | Week 4 pre-dose |
| Ctrough at Stead State (Ctrough_ss) | Weeks 16 and 19 pre-dose |
| Number of Participants with Treatment-emergent Adverse Events | Up to 16 months |
| Number of Participants with Treatment-emergent Serious Adverse Events | Up to 16 months |
| Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs) | Up to 16 months |
| Number of Participants with Andit-drug Antibodies | Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65 |
| Disease-free Survival | Up to 65 weeks |
Countries
Argentina, Bulgaria, Chile, France, Georgia, Germany, Italy, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed