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N-[2-[2-(Dimethylamino)Ethyl-Methylamino]-5-[[4-(1-Methylindol-3-Yl)Pyrimidin-2-Yl]Amino]-6-(2,2,2-Trifluoroethoxy)Pyridin-3-Yl]Prop-2-Enamide

This article discusses a clinical trial investigating the use of Furmonertinib, a new drug containing N-[2-[2-(Dimethylamino)Ethyl-Methylamino]-5-[[4-(1-Methylindol-3-Yl)Pyrimidin-2-Yl]Amino]-6-(2,2,2-Trifluoroethoxy)Pyridin-3-Yl]Prop-2-Enamide, for treating advanced non-small cell lung cancer (NSCLC). The study compares Furmonertinib to standard platinum-based chemotherapy in patients with a specific genetic mutation, aiming to assess its effectiveness and safety as a first-line treatment option.

Table of Contents

What is Furmonertinib?

Furmonertinib is a new medication being studied for the treatment of a specific type of lung cancer. Its scientific name is N-[2-[2-(DIMETHYLAMINO)ETHYL-METHYLAMINO]-5-[[4-(1-METHYLINDOL-3-YL)PYRIMIDIN-2-YL]AMINO]-6-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-3-YL]PROP-2-ENAMIDE. It’s also known by its product code AST2818.[1]

What Condition Does Furmonertinib Treat?

Furmonertinib is being developed to treat advanced non-small cell lung cancer (NSCLC). Specifically, it targets NSCLC with a particular genetic change called an EGFR exon 20 insertion mutation. This type of lung cancer is typically advanced or has spread to other parts of the body (metastatic) and cannot be cured with surgery or radiation therapy.[1]

How Does Furmonertinib Work?

Furmonertinib belongs to a class of drugs called EGFR inhibitors. It works by targeting and blocking the activity of a protein called EGFR (Epidermal Growth Factor Receptor) that has been altered by the exon 20 insertion mutation. By doing this, it aims to slow down or stop the growth of cancer cells.[1]

The FURVENT Clinical Trial

Furmonertinib is currently being studied in a large clinical trial called FURVENT. This is a Phase 3 trial, which means it’s in an advanced stage of testing. The trial is comparing Furmonertinib to standard chemotherapy treatments to see if it’s more effective and safer for patients with this specific type of lung cancer.[1]

Main Goals of the Trial:

  • To see if Furmonertinib can slow down the progression of cancer better than chemotherapy. This is measured by something called progression-free survival (PFS), which is the time from starting treatment until the cancer starts growing again or the patient passes away.[1]
  • To check if Furmonertinib helps patients live longer overall. This is called overall survival (OS).[1]
  • To measure how many patients’ tumors shrink or disappear with Furmonertinib treatment. This is known as the objective response rate (ORR).[1]
  • To assess how Furmonertinib affects patients’ symptoms and quality of life compared to chemotherapy.[1]

Who Can Receive Furmonertinib?

In the clinical trial, there are specific criteria for who can receive Furmonertinib:

Patients who may be eligible:

  • Those with advanced or metastatic non-squamous NSCLC that can’t be cured with surgery or radiation.[1]
  • Patients whose cancer has the EGFR exon 20 insertion mutation.[1]
  • Those who haven’t received any previous treatments for their advanced lung cancer.[1]
  • Patients with brain metastases (cancer that has spread to the brain) may be eligible if their brain tumors have been treated or are not causing symptoms.[1]

Patients who may not be eligible:

  • Those who can’t swallow pills or follow the study procedures.[1]
  • Patients with certain other health conditions that might make the treatment unsafe.[1]

How is Furmonertinib Given?

Furmonertinib is taken as a tablet by mouth. The maximum daily dose being studied is 240 mg. Patients in the trial may receive treatment for up to 60 months (5 years), depending on how well they respond and tolerate the medication.[1]

Potential Benefits of Furmonertinib

While the full benefits are still being studied, researchers hope that Furmonertinib might offer several advantages over current treatments:

  • It may slow down or stop cancer growth more effectively than chemotherapy.[1]
  • It could potentially help patients live longer.[1]
  • As a targeted therapy, it might have fewer side effects than traditional chemotherapy.[1]
  • It’s taken as a pill, which may be more convenient than intravenous chemotherapy.[1]

Possible Side Effects

The full range of side effects for Furmonertinib is still being studied in the clinical trial. As with any cancer treatment, there may be risks and side effects. The trial is carefully monitoring patients for any adverse effects and comparing them to those experienced with chemotherapy.[1]

It’s important to note that Furmonertinib is still an investigational drug. This means it hasn’t been approved for general use yet, and more research is needed to fully understand its effectiveness and safety. Patients interested in this treatment should discuss it with their oncologist to see if participating in a clinical trial might be an option for them.[1]

Aspect Details
Drug Name Furmonertinib
Trial Phase Phase 3
Target Condition Locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
Comparison Furmonertinib vs. platinum-based chemotherapy
Primary Endpoint Progression-Free Survival (PFS)
Secondary Endpoints Overall Survival (OS), Objective Response Rate (ORR), Quality of Life, Safety and Tolerability
Administration Oral tablet, maximum daily dose 240 mg
Key Inclusion Criteria No prior systemic therapy, documented EGFR exon 20 insertion mutation
Key Exclusion Criteria Inability to swallow pills, uncontrolled medical conditions

FAQ

  • What is Furmonertinib? Furmonertinib is a new drug being studied for the treatment of advanced non-small cell lung cancer. It targets a specific genetic mutation called EGFR exon 20 insertion.
  • Who can participate in this clinical trial? The trial is for patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have not received prior systemic treatment and have a specific genetic mutation called EGFR exon 20 insertion.
  • How is Furmonertinib given to patients? Furmonertinib is given orally in tablet form. The maximum daily dose in the trial is 240 mg.
  • What are the main goals of this clinical trial? The main goals are to assess the effectiveness of Furmonertinib compared to standard chemotherapy, evaluate its impact on patients' quality of life, and determine its safety and tolerability.
  • Can patients with brain metastases participate in the trial? Yes, patients with a history of treated brain metastases or new asymptomatic brain metastases are eligible to participate in the trial.

Ongoing Clinical Trials on N-[2-[2-(Dimethylamino)Ethyl-Methylamino]-5-[[4-(1-Methylindol-3-Yl)Pyrimidin-2-Yl]Amino]-6-(2,2,2-Trifluoroethoxy)Pyridin-3-Yl]Prop-2-Enamide

  • Study comparing firmonertinib with osimertinib or afatinib for patients with advanced lung cancer with uncommon EGFR mutations

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Greece Italy Spain

  • Study on the Safety and Effectiveness of Furmonertinib vs. Platinum-Based Chemotherapy for Patients with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    3 1 1 1
    Investigated drugs:
    France Italy The Netherlands Spain

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • EGFR exon 20 insertion mutation: A specific genetic change in the epidermal growth factor receptor (EGFR) gene that can drive cancer growth. This mutation is found in a small percentage of non-small cell lung cancers.
  • Platinum-based chemotherapy: A standard type of chemotherapy that uses platinum-containing drugs, often combined with other medications, to treat various types of cancers, including lung cancer.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Tyrosine Kinase Inhibitor (TKI): A type of targeted therapy that blocks specific enzymes called tyrosine kinases, which are involved in cancer cell growth and survival.
  • CNS metastases: Cancer that has spread to the central nervous system, including the brain and spinal cord.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-furmonertinib-vs-platinum-based-chemotherapy-for-patients-with-advanced-non-small-cell-lung-cancer/