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Study of Amivantamab and Lazertinib Combination vs. Osimertinib vs. Lazertinib for First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

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What is this trial about?

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

The study focuses on patients with Non-Small Cell Lung Cancer that carries an EGFR mutation, specifically either Exon 19del or Exon 21 L858R. These mutations are small changes in the cancer’s DNA that cause the tumor to grow more quickly. The trial compares a new combination of two medicines, amivantamab given through a vein and lazertinib taken as a pill, with the standard pill osimertinib and with a pill that looks the same but contains no active drug (placebo).

The purpose of the study is to see whether the combination works better than the standard pill. Participants are randomly placed into one of the three groups and receive their assigned treatment for several months, with regular clinic visits for safety checks and imaging scans; those in the placebo groups receive a matching inactive capsule.

The size of the tumors is measured using imaging scans and evaluated with a system called RECIST v1.1, which helps determine whether the cancer is shrinking, staying the same, or growing. “Locally advanced” means the cancer has spread beyond its original spot but not to distant parts of the body, while “metastatic” means it has reached other organs.

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

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging scans are performed to establish a baseline for comparison throughout the trial.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of three treatment groups: amivantamab and lazertinib combination therapy, osimertinib, or lazertinib alone.

    The assignment is done to compare the effectiveness of these treatments in patients with specific genetic mutations in their lung cancer.

  3. Step 3

    Treatment administration

    For those receiving amivantamab, the medication is administered through an intravenous infusion. The frequency and duration of these infusions are determined by the study protocol.

    Participants taking lazertinib or osimertinib receive the medication orally in tablet form. The dosage and frequency are specified by the study guidelines.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes periodic blood tests, imaging scans, and physical examinations.

    Participants are required to report any side effects or changes in health to the study team.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are scheduled at specific intervals to evaluate the long-term effects of the treatment.

    These assessments help determine the progression of the disease and the overall effectiveness of the treatment.

  6. Step 6

    End of study

    The study is estimated to conclude by June 2027. At the end of the study, a final assessment is conducted to gather comprehensive data on the treatment outcomes.

    Participants may be offered continued access to the treatment if it is deemed beneficial and safe.

Who can join the trial?

15 criteria

  • Participant must be at least 18 years old or the legal age of consent in the area where the study is conducted.
  • A woman who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
  • A woman must either not be able to have children or agree to use effective birth control methods during the study and for 6 months after the last dose of the study treatment.
  • A woman must agree not to donate eggs for reproduction during the study and for 6 months after the last dose of the study treatment.
  • A man must use a condom during any activity that could result in pregnancy during the study and for 6 months after the last dose of the study treatment. If sexually active with a woman who can have children, his partner must also use effective birth control.
  • A man must agree not to donate sperm for reproduction during the study and for 6 months after the last dose of the study treatment.
  • Participant must be willing and able to follow the lifestyle restrictions required by the study.
  • Participant must have a newly diagnosed, confirmed case of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has not been treated and cannot be cured with surgery or combined chemotherapy and radiation.
  • The tumor must have specific genetic changes called Exon 19del or Exon 21 L858R substitution, confirmed by a test approved by the FDA or another validated test.
  • Participant must provide a sample of the tumor tissue and blood for analysis.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to the level before treatment.
  • Participant must have at least one measurable tumor that has not been treated with radiation. If only one measurable tumor exists, it can be biopsied for diagnosis if necessary.
  • Participant must have proper functioning of organs and bone marrow without recent blood transfusions or treatments to boost blood cell production.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1, which indicates they are fully active or have some symptoms but do not need bed rest.
  • Participant must sign a consent form indicating they understand the study's purpose and procedures and agree to participate.

Who cannot join the trial?

5 criteria

  • Patients who do not have a specific type of lung cancer called EGFR-mutated Non Small Cell Lung Cancer cannot participate.
  • Patients who do not have the specific genetic changes known as Exon 19del or Exon 21 L858R substitution in their cancer cannot participate.
  • Patients who are not in the age range specified for the study cannot participate.
  • Patients who are not part of the clinical trial group specified for the study cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection, cannot participate.
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Investigated drugs

  • Amivantamab

    is a medication used in this trial to treat patients with a specific type of lung cancer. It works by targeting and blocking certain proteins on cancer cells, which can help slow down or stop the growth of the cancer.

  • Lazertinib

    is another medication involved in the trial. It is used to treat lung cancer by specifically targeting and inhibiting the activity of proteins that are involved in the growth and spread of cancer cells.

  • Osimertinib

    is a medication used in the trial as a comparison to the combination of amivantamab and lazertinib. It is designed to target and block specific proteins in cancer cells, helping to control the growth of the cancer.

What is already known about the treatment

  • Amivantamab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). It is a monoclonal antibody that targets specific proteins on cancer cells, helping the immune system to recognize and destroy them. Amivantamab is classified as an anti-cancer agent and is being evaluated for its potential to improve outcomes in patients with specific genetic mutations in their cancer cells.

  • Lazertinib

    Lazertinib is taken orally and is under investigation in clinical trials as a treatment for EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). It works by inhibiting the activity of the epidermal growth factor receptor (EGFR), which is often overactive in certain types of cancer cells, leading to their growth and division. Lazertinib is classified as a tyrosine kinase inhibitor and is being studied for its ability to effectively manage cancer with specific genetic mutations.

  • Osimertinib

    This medication is administered orally and is currently approved for use in treating EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). It functions by blocking the activity of the epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. Osimertinib is a tyrosine kinase inhibitor and is recognized in medical literature for its role in managing cancer with specific genetic mutations.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is known for its slower progression compared to small cell lung cancer. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, indicating it has spread to other parts of the body. A specific mutation in the EGFR gene can drive the growth of cancer cells in some cases. This mutation can affect how the disease progresses and responds to certain treatments.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506576-27-00Protocol code73841937NSC3003Estimated enrolment1 074 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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