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Study of Amivantamab, Lazertinib, and Drug Combination for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer After Osimertinib Failure

Verified siteRegistered drugNo placebo
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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 has spread locally or to distant sites. The cancer in these participants carries a specific genetic change called an EGFR mutation (either Exon 19 deletion or Exon 21 L858R substitution), which can make the tumor grow faster and affect how it responds to treatment.

Two treatment approaches are being compared. One group receives a combination of the antibody therapy amivantamab (given by intravenous infusion) and the oral drug lazertinib, together with standard chemotherapy that includes the platinum‑based drug carboplatin and the chemotherapy agent pemetrexed. The other group receives only the chemotherapy drugs carboplatin and pemetrexed. Chemotherapy works by targeting rapidly dividing cells, which includes cancer cells.

The purpose of the study is to determine whether adding amivantamab and lazertinib to chemotherapy can improve progression‑free survival, meaning the length of time the cancer does not get worse. Participants are randomly assigned to one of the two treatment plans and receive the therapies in cycles, typically every three weeks, with regular clinic visits for infusions, pill intake, and imaging scans that check the size of the tumor.

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

    Joining the study

    Upon joining the study, the participant will be randomly assigned to one of two treatment groups. This assignment is done to compare the effectiveness of different treatment combinations.

  2. Step 2

    Treatment group assignment

    Participants will be assigned to either the combination of amivantamab and lazertinib with platinum-based chemotherapy or to platinum-based chemotherapy alone. The specific treatment plan will depend on the group assignment.

  3. Step 3

    Treatment administration

    For those receiving amivantamab and lazertinib with chemotherapy, amivantamab is administered intravenously, and lazertinib is taken orally. The chemotherapy includes carboplatin and pemetrexed, both given intravenously.

    Participants in the chemotherapy-only group will receive carboplatin and pemetrexed intravenously.

  4. Step 4

    Treatment schedule

    The treatment cycle is repeated every 21 days. The duration of the treatment will depend on the participant's response and any side effects experienced.

  5. Step 5

    Monitoring and assessments

    Regular monitoring will occur throughout the study to assess the participant's health and the effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies.

  6. Step 6

    End of treatment

    The treatment will continue until the disease progresses, unacceptable side effects occur, or the participant decides to stop. After treatment ends, follow-up visits will be scheduled to monitor the participant's health.

Who can join the trial?

14 criteria

  • Must be at least 18 years old or the legal age of consent in the area where the study is conducted.
  • Must have a confirmed diagnosis of a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), with certain genetic changes known as EGFR Exon 19del or Exon 21 L858R mutation.
  • Must have previously been treated with a medication called osimertinib and shown disease progression after this treatment.
  • Must have at least one tumor that can be measured and has not been treated with radiation.
  • If there is a history of cancer spreading to the brain, all brain lesions must have been treated, and no further treatment should be needed at the time of joining the study.
  • Must have a general health status that allows for normal daily activities, classified as ECOG status 0 or 1.
  • Must have adequate function of organs and bone marrow, which includes specific levels of blood cells and liver and kidney function.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to the state before treatment, except for hair loss, mild nerve damage, or mild thyroid issues that are stable with medication.
  • Must agree to sign a document confirming understanding of the study and willingness to participate.
  • Must agree to use a condom during sexual activity to prevent the transfer of treatment effects to others and avoid donating sperm for reproduction during the study and for six months after the last treatment dose.
  • If able to become pregnant, must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
  • If able to become pregnant, must agree to use effective birth control methods during the study and for six months after the last treatment dose.
  • Must agree not to donate eggs for reproduction during the study and for six months after the last treatment dose.
  • Must be willing to follow specific lifestyle guidelines provided in the study protocol.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer other than the specific lung cancer being studied.
  • Patients who have not been diagnosed with the specific genetic changes in their cancer that the study is focusing on.
  • Patients who are not within the age range specified for the study.
  • Patients who are unable to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had certain treatments recently that might interfere with the study results.
  • Patients who have allergies or reactions to the study medications or similar drugs.
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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 included in the trial. It is designed to target and inhibit specific proteins that are involved in the growth and spread of cancer cells, particularly in patients who have a mutation in the EGFR gene.

  • Carboplatin

    is a type of chemotherapy used in the trial. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This can help to shrink tumors and slow the progression of the disease.

  • Pemetrexed

    is also a chemotherapy drug used in the study. It interferes with the cancer cell's ability to use folate, a vitamin that is necessary for cell division. By doing so, it can help to stop the growth of cancer cells.

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 locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and MET pathways, helping to inhibit cancer cell growth and survival. Amivantamab is classified as an antineoplastic agent and is being evaluated for its potential to improve outcomes in patients who have experienced failure with previous treatments like osimertinib.

  • Lazertinib

    Lazertinib is taken orally and is under investigation in clinical trials for its role in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It works by selectively inhibiting the activity of the mutated epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. Lazertinib is classified as a tyrosine kinase inhibitor and is being studied for its potential to provide therapeutic benefits in patients who have not responded to other treatments such as osimertinib.

Investigated diseases

Locally Advanced or Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its spread beyond the original site. It is classified as "locally advanced" when it has spread to nearby tissues or lymph nodes but not to distant body parts. When it becomes "metastatic," it means the cancer has spread to other organs or distant parts of the body. The disease often progresses through stages, starting from localized tumors to more widespread involvement. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506518-33-00Protocol code61186372NSC3002Estimated enrolment776 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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