A Study of Amivantamab and Lazertinib for Adults with EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This study is looking at a type of lung cancer called Non-Small Cell Lung Cancer that has spread to other parts of the body or has grown in a way that cannot be cured with surgery or radiation. Specifically, this study focuses on lung cancer that has certain changes in a gene called EGFR, which stands for epidermal growth factor receptor. These changes are known as EGFR mutations and include specific types called Ex19del and Ex21 L858R. The study will test two different treatment combinations. One group of patients will receive JNJ-61186372, which contains the active substance amivantamab, given as an injection under the skin, together with JNJ-73841937, which contains the active substance lazertinib, taken as a tablet by mouth. This combination will be used as a first treatment for patients who have not yet received other treatments for their advanced lung cancer. The other group of patients will receive JNJ-61186372 combined with platinum-based chemotherapy, which are drugs that contain platinum and are commonly used to treat cancer, and this will be given as a second treatment for patients who have already received one previous treatment.

The purpose of this study is to see how well these treatment combinations work against the lung cancer in patients who have the specific EGFR mutations. The study will look at whether the treatments can slow down or stop the cancer from growing or spreading. Patients in the study will receive their assigned treatment combination and will be monitored regularly by the doctors to check how the cancer is responding and to watch for any side effects. The study is designed as an open-label trial, which means that both the patients and the doctors will know which treatment is being given.

During the study, patients will have regular visits where doctors will perform tests and examinations to measure the size of the cancer and see if it is getting smaller, staying the same, or growing. The study will follow patients for several years to gather information about how long the treatment keeps the cancer under control and how patients feel while taking the medications. This information will help doctors understand whether these treatment combinations could be useful options for patients with this type of lung cancer in the future.

1 Treatment initiation

Upon joining the study, treatment will begin based on the assigned group. There are two treatment approaches in this study.

The first treatment option involves receiving amivantamab in combination with lazertinib as initial treatment. The second treatment option involves receiving amivantamab in combination with platinum-based chemotherapy as second-line treatment.

Amivantamab is administered as an injection under the skin (subcutaneous injection). Lazertinib is taken by mouth in tablet form.

2 Ongoing treatment administration

Treatment will continue according to the prescribed schedule determined by the study protocol.

If assigned to receive amivantamab with lazertinib, the subcutaneous injections of amivantamab will be administered at specified intervals, while lazertinib tablets will be taken orally as directed.

If assigned to receive amivantamab with platinum-based chemotherapy, the subcutaneous injections of amivantamab will be combined with chemotherapy treatment according to the established schedule.

3 Regular monitoring and assessments

Throughout the study, regular assessments will be conducted to monitor the response to treatment.

These assessments will include imaging scans to measure any changes in tumor size according to RECIST v1.1 criteria, which is a standardized method for evaluating whether tumors are shrinking, staying the same, or growing.

The treating physician will review these results to determine how the treatment is working.

4 Continuation of treatment

Treatment will continue as long as it remains beneficial and tolerable.

Any side effects experienced will be monitored and managed according to standard medical practice.

The study is designed to run until November 2030, though individual participation duration may vary based on treatment response and tolerability.

Who Can Join the Study?

  • You must have advanced or metastatic non-small cell lung cancer confirmed by tissue examination under a microscope or cell analysis. Advanced means the cancer has grown extensively in your body, and metastatic means it has spread to other parts of your body. This cancer cannot be treated with the goal of curing it completely.
  • Your cancer must have a specific change in a gene called EGFR mutation. This must be either an Ex19del type or Ex21 L858R type. This change must be confirmed by an approved test performed in a certified laboratory.
  • You must have at least one tumor that can be measured by imaging scans, according to standard measurement rules called RECIST version 1.1. This tumor must not have been previously treated with radiation therapy.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to your baseline condition. Exceptions include hair loss of any severity, mild nerve damage in arms or legs, or mild underactive thyroid that is controlled with medication.
  • You must have an ECOG performance status of 0 to 1. This is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you have some restrictions but can still do light work.
  • You can be male or female.
  • You must be an adult.

Who Cannot Join the Study?

  • The specific exclusion criteria (reasons why a patient cannot participate in this study) have not been provided in the available information.
  • Generally, clinical trials have rules about who cannot join to ensure patient safety and reliable results.
  • Common reasons patients may not be able to participate in cancer treatment studies include having other serious medical conditions, taking certain medications that could interfere with the study treatment, or having abnormal results in blood tests or heart function tests.
  • Some studies exclude patients who have received specific types of cancer treatment recently or who have cancer that has spread to the brain.
  • Pregnant or breastfeeding women (nursing mothers) are typically not allowed to participate in cancer drug studies because the treatment could harm the baby.
  • Patients with severe problems in major organs like the heart, liver, or kidneys may not be eligible.
  • Those who have had severe allergic reactions (bad responses by the body’s defense system) to similar medications in the past may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
Hospital Jerez de la Frontera Jerez De La Frontera Spain
Comite Entreprise Paul Papin Angers France
University Medicine Greifswald Greifswald Germany
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Metaxa Cancer Center Hospital Of Piraeus Piraeus Greece
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Oulu University Hospital Oulu Finland
Henry Dunant Hospital Center Athens Greece
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Turku University Hospital Turku Finland
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Cuf Tejo S.A. Lisbon Portugal
Ziekenhuis Oost Limburg Genk Belgium
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. Trinitatis Leipzig Germany
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Tlxrlddynr Cjmgle Hvoquzvs Thessaloniki Greece
Lcncd Gkouymj Hswnwjuy Ol Atqtia Athens Greece
Aezjfsxcoc Plvuqezg Hrxebvmb Dg Mkpeiqhzm Marseille France
Hbadmdwa Uzeccgisiu Chostll Hpxzvcwn Helsinki Finland
Uur Meisnhmrzahk Yvoir Belgium
Alwtgp Mpvxwhc Cvsbql Soed Thessaloniki Greece
Nanhveaj Ivdzpjvb Ozzsggikf Imb Mosfz Skjuwfenkrpuuukxwhmdzuqqjjqg Izimcemu Bxxnlvbm Cracow Poland
Ktwrstus dat Uxztehilwzzt Muywolfs Avl Munich Germany
Uithnjngitqqhu Cddolrw Kibjqsaxv Gdansk Poland
Hmpahguo Vipd dypuucho Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2025
Finland Finland
Recruiting
01.11.2025
France France
Recruiting
01.11.2025
Germany Germany
Recruiting
01.11.2025
Greece Greece
Recruiting
01.11.2025
Italy Italy
Recruiting
01.11.2025
Poland Poland
Recruiting
01.11.2025
Portugal Portugal
Recruiting
01.11.2025
Spain Spain
Recruiting
01.11.2025

Trial locations

Investigated drugs:

Amivantamab is a medication given as an injection under the skin. It is being tested as a treatment for a type of lung cancer called non-small cell lung cancer that has specific changes in a gene called EGFR. In this study, it is being given together with other medications to see if it can help stop the cancer from growing.

Lazertinib is a medication being tested in combination with amivantamab for patients who are receiving their first treatment for lung cancer with EGFR gene changes. It works by targeting the abnormal proteins that help cancer cells grow.

Platinum-based chemotherapy refers to a group of cancer-fighting medications that contain platinum. In this study, these medications are being given together with amivantamab to patients who are receiving their second treatment for lung cancer after their first treatment has stopped working.

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and accounts for the majority of all lung cancer cases. The disease develops when cells in the lung tissue begin to grow abnormally and uncontrollably. In this study, the focus is on cases with specific EGFR mutations, which are changes in a gene that can cause cells to grow and divide more rapidly. The cancer can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, meaning it has spread to distant parts of the body. As the disease progresses, the abnormal cells continue to multiply and can form tumors that interfere with normal lung function. The presence of EGFR mutations makes this a distinct subtype of non-small cell lung cancer with particular growth patterns.

Trial ID:
2025-520730-28-00
Protocol code:
61186372NSC2012
Trial Phase:
Therapeutic exploratory (Phase II)

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