In short
Nazartinib (EGF816) is an investigational drug being studied in clinical trials for the treatment of non-small cell lung cancer (NSCLC), particularly in patients with EGFR mutations. This article summarizes key information from clinical trials evaluating nazartinib alone and in combination with other targeted therapies for NSCLC. The trials aim to determine the safety, efficacy, and optimal dosing of nazartinib in different patient populations and treatment settings.
At a glance
- Drug Name
- Nazartinib (EGF816)
- Target Disease
- Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR mutations
- Mechanism of Action
- EGFR tyrosine kinase inhibitor
- Administration
- Oral, once daily
- Key Combinations
- Capmatinib (INC280), TNO155
- Primary Outcomes
- Safety, tolerability, maximum tolerated dose, recommended Phase 2 dose
- Secondary Outcomes
- Overall response rate, progression-free survival, pharmacokinetics
- Patient Populations
- Treatment-naive and previously treated NSCLC patients with various EGFR mutation profiles
What is Nazartinib?
Nazartinib, also known by its research name EGF816, is a promising new drug being studied for the treatment of certain types of lung cancer. It belongs to a class of medications called EGFR-TKIs, which stands for Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors. These drugs work by targeting specific proteins that are involved in the growth and spread of cancer cells.
How Nazartinib Works
Nazartinib is designed to target and block the activity of a specific protein called EGFR (Epidermal Growth Factor Receptor) that is found on the surface of some cancer cells. In some types of lung cancer, this protein is mutated or overactive, causing the cancer cells to grow and divide uncontrollably. By inhibiting this protein, nazartinib aims to slow down or stop the growth of cancer cells.
Conditions Treated by Nazartinib
Nazartinib is primarily being studied for the treatment of non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. This type of lung cancer is often referred to as "EGFR-mutant NSCLC." The drug is being investigated for use in patients with advanced or metastatic NSCLC, which means the cancer has spread beyond the lungs to other parts of the body.
Clinical Trials Involving Nazartinib
Several clinical trials are currently underway to evaluate the safety and effectiveness of nazartinib: A Phase Ib/II study (NCT02335944) is investigating nazartinib in combination with another drug called capmatinib for patients with EGFR-mutant NSCLC. A rollover study (NCT03040973) is allowing patients who have previously participated in nazartinib trials to continue receiving the treatment if they are benefiting from it. A Phase I study (NCT03114319) is exploring the use of nazartinib in combination with another experimental drug called TNO155 for patients with advanced EGFR-mutant NSCLC. These trials aim to determine the best dosage, evaluate the drug's safety profile, and assess its effectiveness in treating lung cancer.
Dosage and Administration
Nazartinib is taken orally, usually once a day. In clinical trials, various doses have been studied, ranging from 50 mg to 150 mg daily. The exact dosage may depend on the specific trial and the patient's individual characteristics. It's important to note that the optimal dose is still being determined through these studies.
Potential Side Effects
As with any medication, nazartinib may cause side effects. The full range of potential side effects is still being studied in clinical trials. Common side effects of EGFR-TKIs like nazartinib may include: Skin rash or dryness Diarrhea Fatigue Loss of appetite Nausea It's important to report any side effects to your healthcare provider if you are participating in a clinical trial involving nazartinib.
Combination Therapy with Nazartinib
Researchers are exploring the use of nazartinib in combination with other cancer drugs to potentially enhance its effectiveness: Nazartinib + Capmatinib: This combination is being studied in patients with EGFR-mutant NSCLC. Capmatinib targets another protein called MET, which may also be involved in cancer growth. Nazartinib + TNO155: This combination is being investigated in a Phase I trial. TNO155 is a drug that targets a protein called SHP2, which may play a role in cancer cell signaling. These combination approaches aim to target multiple pathways involved in cancer growth, potentially leading to better outcomes for patients.