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Life sciences · Phase 3 Trial
ClinicalTrials.gov · November 3, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT05388669). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 418 participants (ACTUAL). Conditions: Advanced or Metastatic Non-small Cell Lung Cancer. Interventions: DRUG: Lazertinib; DRUG: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF); DRUG: Amivantamab Intravenous. 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 , Pre-dose on Cycle 4 Day 1 (each cycle of 28 days); For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab , 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 , 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. Brief summary: 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.