The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
418
Lazertinib tablets will be administered orally.
Amivantamab injection will be administered subcutaneously by manual injection.
Amivantamab will be administered by IV infusion.
City of Hope Duarte
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
City of Hope Long Beach Elm
Long Beach, California, United States
National Jewish Health
Denver, Colorado, United States
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States
For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Time frame: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab
Ctrough was the observed serum concentration of Amivantamab immediately prior to the next drug administration.
Time frame: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
AUC (Day 1-15) defined as area under the concentration time curve from Cycle 2 Day 1 to Day 15 were reported.
Time frame: Cycle 2: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hours (hrs) post-dose on Day 1; Arm B: pre-infusion, end of infusion (EOI)+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
Objective Response Rate (ORR)
Time frame: Up to 3 years 4 months
Progression-Free Survival (PFS)
Time frame: Up to 3 years 4 months
Duration of Response (DOR)
Time frame: Up to 3 years 4 months
Time to Response (TTR)
Time frame: Up to 3 years 4 months
Number of Participants With Adverse Events (AEs)
Time frame: Up to 3 years 4 months
Number of Participants With AEs by Severity
Time frame: Up to 3 years 4 months
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to 3 years 4 months
Number of Participants With Clinical Laboratory Abnormalities by Severity
Time frame: Up to 3 years 4 months
Number of Participants With Infusion Related Reactions (IRRs)
Time frame: Up to 3 years 4 months
Number of Participants With IRRs by Severity
Time frame: Up to 3 years 4 months
For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
Time frame: Pre-dose on Cycle 2 Day 1 (each cycle of 28 days)
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Time frame: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days)
Model-Predicted Area Under the Concentration Time Curve of Amivantamab at Steady State From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 4
Time frame: Cycle 4: Arm A: pre-dose, 24, 48, 72, 96, 168, and 360 hrs post-dose on Day 1; Arm B: preinfusion, EOI+10 minutes, EOI+2, EOI+6, EOI+24, EOI+48, EOI+72, EOI+168, and EOI+360 hrs post dose on Day 1
Percentage of Participants With Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
Time frame: Up to 3 years 4 months
Percentage of Participants With Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
Time frame: Up to 3 years 4 months
Change From Baseline in Therapy Administration Satisfaction Questionnaire (TASQ) as Assessed Over Time
Time frame: From baseline (Day 1, Cycle 1) to 3 years 4 months (each cycle of 28 days)
Participant Chair Time
Time frame: Up to 3 years 4 months
Participant Chair Time in Treatment Room
Time frame: Up to 3 years 4 months
Duration of Treatment Administration
Time frame: Up to 3 years 4 months
Active Health Care Professional (HCP) Time For Drug Preparation, Treatment Administration and Post-treatment Monitoring
Time frame: Up to 3 years 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orlando Health
Orlando, Florida, United States
University of Kansas
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
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