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

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What is this study about?

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.

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 randomization

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

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Cuf Descobertas S.A. Lisbon Portugal
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Justus-Liebig-Universitaet Giessen Giessen Germany
Auemmutjxo Pczbfggw Huarrbqc Dl Mlcbbjfaf Marseille France
Nprmmhee Ihexrelf Ofpttqnhi Igd Mkhno Sfdtpxhpsidymjncrnuidyevpoqz Isngslfi Bwbjildc Cracow Poland
Fktvotvwc Pybl Lq Ijifreilsumxw Btuuswtuq Dib Hmmomcgg Ufzdzavmonskj Ld Pkb Madrid Spain
Hjkqbrnx Uloviskbfeqtz dk A Ccrvyy A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
30.09.2022
Germany Germany
Not recruiting
30.09.2022
Italy Italy
Not recruiting
30.09.2022
Poland Poland
Not recruiting
30.09.2022
Portugal Portugal
Not recruiting
30.09.2022
Spain Spain
Not recruiting
30.09.2022

Trial locations

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.

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 ID:
2024-512045-16-00
Protocol code:
61186372NSC3004
Trial Phase:
Therapeutic confirmatory (Phase III)

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