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Nazartinib

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.

Table of Contents

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[1]. 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[1].

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[1][3].

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[1].
  • 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[2].
  • 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[3].
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[1][2].

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[1].

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[1].
  • 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[3].
These combination approaches aim to target multiple pathways involved in cancer growth, potentially leading to better outcomes for patients.

Aspect Details
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

FAQ

  • What is nazartinib? Nazartinib (also known as EGF816) is an investigational drug that targets and inhibits the EGFR protein in cancer cells. It is being studied as a potential treatment for non-small cell lung cancer, especially in patients whose tumors have EGFR mutations.
  • What types of patients are being studied in nazartinib clinical trials? The clinical trials are primarily studying patients with advanced non-small cell lung cancer who have EGFR mutations. This includes patients who are newly diagnosed as well as those who have progressed after previous EGFR inhibitor treatments.
  • How is nazartinib administered? Nazartinib is given as an oral medication, typically taken once daily. The exact dose may vary depending on the specific trial and treatment group.
  • What are some of the combination therapies being tested with nazartinib? Nazartinib is being studied in combination with other targeted therapies, including capmatinib (which targets MET) and TNO155 (which targets SHP2). These combinations aim to improve efficacy and overcome resistance mechanisms.
  • What are the main goals of the nazartinib clinical trials? The main goals include assessing the safety and tolerability of nazartinib, determining the optimal dose, evaluating its effectiveness in treating NSCLC (measured by tumor response and survival outcomes), and studying how the drug behaves in the body (pharmacokinetics).

Ongoing Clinical Trials on Nazartinib

  • Study for Patients with Advanced Cancer Continuing Ribociclib Treatment

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study for Patients with cMET-Dependent Cancers to Continue Treatment with Capmatinib, Nazartinib, and Gefitinib

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Germany Italy

Glossary

  • EGFR: Epidermal Growth Factor Receptor, a protein on the surface of cells that helps them grow and divide. Some NSCLC tumors have mutations in the EGFR gene, making it a target for cancer treatments.
  • NSCLC: Non-Small Cell Lung Cancer, the most common type of lung cancer, accounting for about 80-85% of all cases.
  • T790M mutation: A specific mutation in the EGFR gene that can cause resistance to some EGFR inhibitor treatments. Nazartinib is being studied in patients with and without this mutation.
  • MET: A gene that can be involved in cancer growth and resistance to EGFR inhibitors. Capmatinib, studied in combination with nazartinib, targets MET.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated. This helps determine the best dosing for the medication.
  • RECIST 1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure if tumors are responding to treatment in cancer clinical trials.
  • RP2D: Recommended Phase 2 Dose, the dose of a drug determined to be appropriate for further testing in larger clinical trials based on safety and early efficacy data.

References

  1. https://clinicaltrials.gov/study/NCT02335944
  2. https://clinicaltrials.gov/study/NCT03040973
  3. https://clinicaltrials.gov/study/NCT03114319