Treatment Study for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Title

61186372NSC2012 (COPERNICUS) – A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Description

The purpose of this study is to help researchers understand more about the possible effectiveness and safety of the combination of amivantamab and lazertinib in participants with non-small cell lung cancer (NSCLC) who have a specific mutation in the EGFR (epidermal growth factor receptor) gene. Amivantamab SC (given as an injection under the skin) and Lazertinib are investigational drugs. “Investigational” means that it is not approved by the United States (US) Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied. You are being asked to participate in this cohort (Cohort 1) based on the stage of your NSCLC. A cohort is also known as a group of people who have something in common.

Amivantamab (JNJ-61186372) is an antibody. Antibodies are proteins that specifically recognize and bind (connect) to other types of proteins called antigens. Antibodies and antigens can work together to help your immune system fight cancer cells. As studied in test tubes and animals, amivantamab binds to two different types of antigens that can be found on cancer cells. One type of antigen is the epidermal growth factor receptor, also called EGFR. The other type of antigen is called mesenchymal-epithelial transition factor (MET).

Some drugs that bind to EGFR have been approved by the FDA and are in use in patients with several different types of cancer. These drugs include: erlotinib, gefitinib, afatinib, panitumumab, cetuximab, and osimertinib. When one of these drugs binds to EGFR on a cancer cell, the growth of the cell is decreased or completely stops.

Drugs that only bind to MET have been approved by regulatory authorities for the treatment of metastatic non-small cell lung cancer. When one of these types of drugs binds to MET on a cancer cell, the cell can’t get the signals it needs to grow.

Amivantamab IV (intravenously, given through a vein), as a single therapy, is currently approved in more than 30 countries worldwide for patients with locally advanced or metastatic EGFR Exon 20 insertion non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy. However, in countries where it is not approved, it can only be used in a research study such as this one.

Lazertinib belongs to a class of drugs called EGFR tyrosine kinase inhibitors (TKI). When a tyrosine kinase inhibitor binds to EGFR on a cancer cell, the growth of the cell is slowed down or stopped. Lazertinib can recognize and attach to cancer cells that have had changes in the EGFR. Because it can get into brain tissue, it is thought that lazertinib can also work on cancer cells in your brain.

Lazertinib, as a single therapy, is approved in South Korea for use in patients with locally advanced or metastatic EGFR T790M mutation positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR TKI therapy. Lazertinib is also approved in South Korea for patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations. Lazertinib, as a single therapy, is not approved for use by the U.S. Food and Drug Administration (FDA) or any Regulatory Authority in the European Economic Area (EEA), Eastern Europe, Russia, or countries in Asia outside of South Korea.

Amivantamab (given by IV) and lazertinib are FDA-approved medicines used together as a first treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR mutations (exon 19 deletion or exon 21 L858R), confirmed by an FDA-approved test. However, this approval does not include the combination of amivantamab SC (given as an injection under the skin) and lazertinib. Therefore, they can only be used in a research study like this.

If you agree to participate in this study, your participation may last up to 36 months (about 3 years).

In order to participate you must meet the following criteria:

• Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy.
• Have an epidermal growth factor resistance-mutation (EGFRm) that is an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended.
• Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated.

You will be excluded from the study if any of the following criteria apply to you:

• Have medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis.
• Have had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
• Have uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing).

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.