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Phase 2 Neoadjuvant Study of Amivantamab with Lazertinib in Resectable EGFR‑Mutated Non‑Small Cell Lung Cancer Patients

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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 Non-small Cell Lung Cancer, a common form of lung cancer that can sometimes be removed by surgery. Some tumors have an EGFR-mutated gene, which helps the cancer grow. The trial tests an injectable medicine called JNJ-61186372 (amivantamab) together with an oral tablet called JNJ-73841937 (lazertinib), or with standard chemotherapy drugs carboplatin and pemetrexed, to see which combination works best before surgery.

The purpose of the study is to evaluate the antitumor effect of the drug combinations in people with resectable, EGFR‑mutated stage II‑IIIB disease when given in a neoadjuvant setting, meaning the treatment is given before the tumor is removed.

Participants receive the assigned medication(s) for several weeks, then undergo surgery to remove the tumor, and continue to be monitored for safety and how well the cancer responded. The study follows each person from the start of treatment through surgery and the recovery period, collecting information about any side effects and the amount of cancer left after the operation.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessments
After enrollment, you will undergo baseline tests that may include physical examination, blood tests, and imaging studies to confirm the extent of your lung cancer.
These assessments create a reference point for evaluating how the study medicines affect your disease.
Step 2
Start neoadjuvant treatment
You will begin receiving the study medicines in the period before surgery, called neoadjuvant therapy.
The oral medication lazertinib is taken as a tablet; the exact dose and how often you take it will be specified by the study protocol.
The injectable medication amivantamab is given by subcutaneous (under the skin) injection; the dose and frequency are also defined by the protocol.
If you are assigned to the chemotherapy arm instead of the combination, you will receive carboplatin and pemetrexed according to the protocol schedule.
Step 3
Regular monitoring visits
During the treatment period you will attend scheduled clinic visits where health professionals will check for side effects, repeat blood tests, and may perform additional imaging to see how the tumor is responding.
Any adjustments to the medication dose or schedule will be made based on these safety and efficacy evaluations.
Step 4
Pre‑surgical evaluation
Once the neoadjuvant treatment course is completed, you will undergo a final assessment to determine if you are ready for surgery.
This evaluation includes imaging and possibly repeat biopsies to measure the amount of remaining cancer cells.
Step 5
Surgery
The planned surgical procedure to remove the lung tumor will be performed.
The surgical specimen will be examined by a central pathology laboratory to assess the primary study endpoint, which looks for a low percentage of remaining cancer cells.
Step 6
Post‑operative follow‑up
After surgery you will have follow‑up visits to monitor recovery, manage any complications, and continue safety assessments.
Additional imaging or laboratory tests may be done according to the study schedule.
Step 7
Final study visit
At the end of the study period you will attend a final visit where all remaining data are collected.
This includes final imaging, laboratory results, and a summary of any side effects experienced during the trial.

Who can join the trial?

5 criteria

You must have a confirmed diagnosis of non‑small cell lung cancer (NSCLC) that is not the “squamous” type, and the cancer must be at a stage that doctors consider completely removable by surgery (Stage II‑IIIB with N2 involvement, which means the cancer has spread to certain nearby lymph nodes).
Doctors from a team of different specialties must agree that the whole tumor can be surgically removed.
You need to agree to have a small tissue sample taken (a biopsy) for testing before the study starts, if there isn’t already enough tumor tissue available.
If you have had another cancer in the past or at the same time (a second malignancy), it must be a type that is unlikely to affect the safety or effectiveness measurements of this study, and the study’s medical monitor must approve it.
Your overall health level must be good, measured by the ECOG performance status scale as a 0 (fully active) or 1 (restricted but able to do light work).

Who cannot join the trial?

5 criteria

Having a history of uncontrolled illness, meaning a disease that has not been well‑managed or is currently out of control.
Having had, currently having, or possibly having (based on screening images) a non‑infectious interstitial lung disease (ILD) or pneumonitis, which are types of lung scarring or inflammation that are not caused by an infection.
Having a known or suspected allergy, hypersensitivity, or intolerance to the inactive ingredients (excipients) in the drug combinations used in the study.
Having other major genetic changes called primary driver mutations (such as ALK, MET, HER2, ROS1, NTRK, BRAF, RET, or KRAS) in the tumor, except for the specific EGFR mutations Exon 19del or Exon 21 L858R that the study is targeting.
Having received any prior systemic anti‑cancer therapy for this lung cancer, including medicines known as EGFR‑tyrosine kinase inhibitors (TKIs), chemotherapy, biologic therapy, immunotherapy, or any experimental (investigational) drug.

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Verified sites

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Hospital General Universitario Gregorio Maranon
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Madrid, Spain
Hospital Vall d’Hebron
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Barcelona, Spain

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Investigated drugs

Lazertinib
is a pill taken by mouth that belongs to a group of medicines called targeted therapies. It works by blocking a specific change (mutation) in the EGFR gene that can cause lung cancer cells to grow. In this study, patients take lazertinib before surgery to see if it can shrink the tumor and make the operation easier.
Amivantamab
is given as a liquid that is injected under the skin. It is a type of treatment called a monoclonal antibody, which helps the immune system recognize and attack cancer cells that have the EGFR mutation. The trial tests amivantamib together with lazertinib or with chemotherapy to see if the combination improves outcomes before surgery.
Carboplatin
is a chemotherapy drug that is given through an IV (intravenous) infusion. It works by damaging the DNA of rapidly dividing cancer cells, which can stop them from growing. In this trial, carboplatin is used together with another chemotherapy drug as an alternative treatment option to compare with the targeted therapy combination.
Pemetrexed
is another chemotherapy medication that is also given by IV infusion. It interferes with the way cancer cells make DNA and proteins, helping to slow or stop tumor growth. Pemetrexed is paired with carboplatin in the study to evaluate how this standard chemotherapy regimen works compared with the targeted therapy approach before surgery.

What is already known about the treatment

Lazertinib
This medication is taken as an oral tablet that you swallow. It is a third‑generation EGFR tyrosine‑kinase inhibitor that blocks the abnormal EGFR protein found in many lung cancers, stopping the signal that makes cancer cells grow. Lazertinib is approved for use in some countries for EGFR‑mutated non‑small cell lung cancer and is being further studied in clinical trials. It belongs to the targeted therapy class of EGFR inhibitors.
Amivantamab
This drug is given as a subcutaneous injection of a clear solution. It is a bispecific monoclonal antibody that attaches to both EGFR and MET receptors on cancer cells, blocking their signals and recruiting the immune system to destroy the cells. Amivantamab is already approved for certain EGFR‑mutated lung cancers and is now being tested as a neoadjuvant treatment before surgery. It is classified as a targeted bispecific antibody therapy.

Investigated diseases

Non-small Cell Lung Cancer - Non‑small Cell Lung Cancer is a group of cancers that begin in the lining of the lung’s airways. It usually starts as a small tumor that may stay localized for a while, then can grow into surrounding lung tissue. As it expands, it can involve nearby lymph nodes and may spread through the bloodstream to other organs. The disease often progresses in stages, with each stage reflecting a larger tumor size or farther spread. Growth can be slow compared to other lung cancers, but over time the tumor can become larger and affect breathing. Symptoms may appear as the tumor enlarges or spreads.