Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Lazertinib and Subcutaneous Amivantamab with Intravenous Amivantamab for Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as EGFR-mutated advanced or metastatic non-small cell lung cancer. This type of cancer has specific changes in the epidermal growth factor receptor (EGFR) gene, which can affect how cancer grows and responds to treatment. The study is investigating two treatments: lazertinib, which is taken as a tablet, and amivantamab, which is given as an injection. Amivantamab is being tested in two forms: one that is injected under the skin (subcutaneous) and another that is given through a vein (intravenous).

The purpose of the study is to compare the effectiveness of the subcutaneous form of amivantamab with the intravenous form in patients whose cancer has progressed after treatment with a medication called osimertinib and chemotherapy. Participants in the study will receive either lazertinib with subcutaneous amivantamab or intravenous amivantamab. The study will help determine if the subcutaneous form is as effective as the intravenous form.

During the study, participants will receive treatment over a period of time and will be monitored regularly to assess how well the treatment is working and to check for any side effects. The study aims to provide more information about these treatments and their potential benefits for patients with this specific type of lung cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility for the trial. This includes verifying the presence of advanced or metastatic non-small cell lung cancer with specific genetic mutations.

    The patient must have previously received treatment with osimertinib and platinum-based chemotherapy.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: one receiving subcutaneous amivantamab and lazertinib, and the other receiving intravenous amivantamab.

  3. Step 3

    Treatment administration

    For the group receiving subcutaneous amivantamab, the medication is administered as a solution for injection.

    For the group receiving intravenous amivantamab, the medication is administered as a solution for infusion.

    Lazertinib is provided in tablet form and taken orally.

  4. Step 4

    Treatment cycle

    The treatment is administered in cycles. The specific schedule and dosage are determined by the study protocol and the patient's response to treatment.

    The primary goal is to assess the effectiveness of subcutaneous versus intravenous administration of amivantamab.

  5. Step 5

    Monitoring and evaluation

    The patient's response to treatment is regularly monitored through medical evaluations and tests.

    The primary endpoint is the concentration of amivantamab in the blood at steady state, measured at specific times during the treatment cycle.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by August 2025, at which point the data will be analyzed to determine the outcomes of the study.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with specific changes in the **EGFR** gene. This can be confirmed by a test approved by the **FDA** or another validated test.
  • Must have experienced disease progression after treatment with **osimertinib** (or another approved 3rd generation **EGFR** tyrosine kinase inhibitor) and platinum-based chemotherapy. The order of these treatments does not matter.
  • Must have at least one measurable tumor according to specific criteria used to evaluate tumors.
  • Must have a performance status of 0 to 1 on a scale used to assess how the disease affects daily living abilities.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to the level before treatment, except for hair loss, mild nerve damage, and mild thyroid issues that are stable with treatment.
  • Both males and females are eligible to participate.
  • Participants must be adults, as the study includes age ranges typically for adults.

Who cannot join the trial?

3 criteria

  • Patients who do not have **EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer**. This is a specific type of lung cancer with a mutation in the **EGFR** gene, which affects how cells grow.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Lazertinib

    is a medication used in this trial for patients with advanced or metastatic non-small cell lung cancer that has specific mutations. It is being studied to see how well it works in combination with another medication after the cancer has progressed despite previous treatments.

  • Amivantamab

    is another medication involved in this trial. It is used to treat patients with non-small cell lung cancer that has certain genetic changes. The study is comparing two ways of giving this medication: one is through a subcutaneous injection, which means it is injected under the skin, and the other is through an intravenous infusion, which means it is given directly into a vein. The goal is to see if the subcutaneous method is as effective as the intravenous method.

What is already known about the treatment

  • Lazertinib

    Lazertinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating EGFR-mutated advanced or metastatic non-small cell lung cancer. It is a targeted therapy that works by inhibiting the activity of the epidermal growth factor receptor (EGFR), which is often overactive in certain types of cancer cells. Lazertinib belongs to the class of medications known as tyrosine kinase inhibitors, which block specific enzymes involved in the growth and spread of cancer cells.

  • Amivantamab

    Amivantamab is administered either intravenously or subcutaneously and is being evaluated in clinical trials for its use in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer. It is a monoclonal antibody that targets both the EGFR and MET receptors, interfering with the pathways that promote cancer cell growth and survival. Amivantamab is classified as a bispecific antibody, designed to bind to two different targets on cancer cells, thereby enhancing its therapeutic effects.

Investigated diseases

EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. The disease is classified as advanced or metastatic when it has spread beyond the lungs to other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer progresses, it can affect various organs and systems, leading to a decline in overall health. The focus of research often involves understanding the behavior of these mutations and finding effective ways to manage the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512045-16-00Protocol code61186372NSC3004Estimated enrolment418 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).