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A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
Clinicaltrials.gov:
EU CTIS:
#2024-512045-16-00
EudraCT:
J&J ID:
#CR109211
Other:
#61186372NSC3004
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Trials at a glance
Status
Enrollment complete
Condition
Advanced or Metastatic Non-small Cell Lung Cancer
Trial type
Interventional
Trial phase
Phase 3
Investigational
product
product
Amivantamab Intravenous
Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Lazertinib
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
August 5, 2022
Trial end date
June 30, 2027
CT.gov ID
#NCT05388669
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
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.
Primary outcome measures
- 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
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab
- Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2
Secondary outcome measures
- Objective Response Rate (ORR)
- Progression-Free Survival (PFS)
- Duration of Response (DOR)
- Time to Response (TTR)
- Number of Participants With Adverse Events (AEs)
- Number of Participants With AEs by Severity
- Number of Participants With Clinical Laboratory Abnormalities
- Number of Participants With Clinical Laboratory Abnormalities by Severity
- Number of Participants With Infusion Related Reactions (IRRs)
- Number of Participants With IRRs by Severity
- 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
- For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
- 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
- Percentage of Participants With Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
- Percentage of Participants With Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
- Change From Baseline in Therapy Administration Satisfaction Questionnaire (TASQ) as Assessed Over Time
- Participant Chair Time
- Participant Chair Time in Treatment Room
- Duration of Treatment Administration
- Active Health Care Professional (HCP) Time For Drug Preparation, Treatment Administration and Post-treatment Monitoring
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