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

Conditions

• Advanced or Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lazertinib — DRUG
  Lazertinib tablets will be administered orally.
• Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF) — DRUG
  Amivantamab injection will be administered subcutaneously by manual injection.
• Amivantamab Intravenous — DRUG
  Amivantamab will be administered by IV infusion.

Study Details

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.

Key Dates

Start date

Aug 5, 2022

Status verified

Jun 2026

Primary completion

Jan 3, 2024

Completion

Jun 30, 2027

Study Design

Enrollment

418 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Lazertinib with Amivantamab SC-CF
  Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.
• Experimental: Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion
  Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.

Primary Outcome Measure

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 [ Time Frame: Pre-dose on Cycle 4 Day 1 (each cycle of 28 days) ]

Locations (17)

Related coverage on Hipa.ai

• Rybrevant Subcutaneous Formulation Shows Higher Serum Levels in EGFR+ NSCLC
  Amivantamab · Feb 2, 2026 · ClinicalTrials.gov
• Amivantamab Subcutaneous Formulation Bioequivalent to IV in Advanced NSCLC
  Amivantamab · Jan 3, 2024 · ClinicalTrials.gov

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