#1 Clinical Trials Search in Europe

Capmatinib

This article explores the use of Capmatinib, a targeted therapy drug, in clinical trials for treating non-small cell lung cancer (NSCLC). Capmatinib is being studied, particularly in patients with MET exon 14 skipping mutations or MET amplification. The trials aim to evaluate its efficacy, safety, and potential benefits in various treatment settings, including as a first-line treatment and in combination with other therapies.

Table of Contents

What is Capmatinib?

Capmatinib, also known by its brand name Tabrecta or research code INC280, is a medication used to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC)[1]. It belongs to a class of drugs called targeted therapies, which are designed to attack cancer cells with specific genetic changes while minimizing damage to healthy cells[2].

How Capmatinib Works

Capmatinib works by targeting a specific protein called MET (mesenchymal-epithelial transition). In some lung cancers, the MET protein becomes overactive due to genetic changes, such as mutations in the MET gene or extra copies of the gene (called amplification). This overactivity can cause cancer cells to grow and spread[2].

Capmatinib is designed to block the activity of the MET protein. By doing so, it may slow down or stop the growth of cancer cells that depend on this protein to survive and multiply[2].

Conditions Treated by Capmatinib

Capmatinib is primarily used to treat advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have specific genetic changes[1]. These changes include:

  • MET exon 14 skipping mutations: This is a change in the MET gene that causes part of the gene (exon 14) to be missing, leading to an overactive MET protein[3].
  • MET amplification: This occurs when there are extra copies of the MET gene in the cancer cells[1].

Capmatinib is typically used in patients who have already tried other treatments or as a first-line treatment in some cases[3].

Effectiveness of Capmatinib

Clinical trials have shown that Capmatinib can be effective in treating NSCLC with MET alterations. Some key measures of its effectiveness include:

  • Overall Response Rate (ORR): This is the percentage of patients whose tumors shrink or disappear after treatment. In some studies, the ORR for Capmatinib was significant, especially in patients with MET exon 14 skipping mutations[1].
  • Duration of Response (DOR): This measures how long the tumor response lasts. Some patients have shown long-lasting responses to Capmatinib[1].
  • Progression-Free Survival (PFS): This is the length of time during and after treatment that a patient lives with the disease without it getting worse[4].

It’s important to note that the effectiveness can vary from person to person, and your doctor will consider your individual case when recommending treatment.

How Capmatinib is Administered

Capmatinib is taken orally in the form of tablets. The typical dose is 400 mg twice daily[1]. Your doctor will provide specific instructions on how to take the medication, including whether to take it with or without food. It’s important to follow these instructions carefully and to inform your healthcare team about any other medications you’re taking[3].

Potential Side Effects

Like all medications, Capmatinib can cause side effects. Common side effects may include:

  • Nausea and vomiting
  • Fatigue
  • Swelling in the legs or hands
  • Decreased appetite
  • Changes in liver function tests

Your healthcare team will monitor you for side effects and can help manage them if they occur. It’s important to report any new symptoms or changes in your health to your doctor[5].

Ongoing Research

Research on Capmatinib is ongoing to better understand its effectiveness, safety, and potential use in different situations. Some areas of current research include:

  • Using Capmatinib in combination with other cancer treatments[5].
  • Studying its effectiveness in treating brain metastases (when lung cancer spreads to the brain)[6].
  • Using Capmatinib before and after surgery in certain stages of lung cancer[7].
  • Evaluating its effectiveness in real-world settings outside of clinical trials[8].

These ongoing studies may lead to new ways of using Capmatinib to treat lung cancer in the future.

Aspect Details
Drug Name Capmatinib (also known as INC280)
Target Population NSCLC patients with MET exon 14 skipping mutations or high MET amplification
Mechanism of Action Selective inhibitor of the cMET protein and MET signaling pathway
Administration Oral tablets, typically 400 mg twice daily
Key Efficacy Measures Overall response rate (ORR), Progression-free survival (PFS), Duration of response (DOR), Disease control rate (DCR), Overall survival (OS)
Treatment Settings First-line, second-line, and later lines of therapy; monotherapy and combination therapy
Notable Trials GEOMETRY mono-1, neoadjuvant/adjuvant studies, combination with immunotherapy
Safety Assessments Monitoring of adverse events, laboratory tests, and vital signs
Additional Investigations Pharmacokinetics, intracranial efficacy in brain metastases, quality of life measures

FAQ

  • What is Capmatinib and how does it work? Capmatinib is a targeted therapy drug that specifically blocks the cMET protein. It works by inhibiting the MET signaling pathway, which is often dysregulated in certain types of non-small cell lung cancer. By blocking this pathway, Capmatinib may help slow or stop the growth and survival of cancer cells.
  • Which patients are most likely to benefit from Capmatinib? Capmatinib is primarily being studied in patients with non-small cell lung cancer who have MET exon 14 skipping mutations or high MET amplification. These genetic alterations are believed to make the cancer more responsive to MET inhibitors like Capmatinib.
  • What are the main outcomes being measured in Capmatinib clinical trials? The main outcomes being measured include overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS). Researchers are also assessing safety profiles and pharmacokinetics of the drug.
  • Is Capmatinib being studied in combination with other treatments? Yes, some trials are investigating Capmatinib in combination with other treatments. For example, one study is evaluating the combination of Capmatinib with pembrolizumab (an immunotherapy drug) compared to pembrolizumab alone in certain NSCLC patients.
  • What are the potential side effects of Capmatinib? While specific side effects can vary, clinical trials are closely monitoring for adverse events. Common side effects of targeted therapies may include fatigue, nausea, diarrhea, and skin reactions. The trials are designed to assess both the efficacy and safety profile of Capmatinib in different patient populations and treatment settings.

Ongoing Clinical Trials on Capmatinib

  • Study on the Effectiveness of Tepotinib and Drug Combination for Patients with Advanced Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Norway

  • Study on Everolimus and Drug Combination for Children with Relapsed or Refractory Pediatric Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy The Netherlands Spain

  • Study on Advanced Soft-Tissue Sarcoma: Testing Futibatinib and Drug Combination for Patients with Unresectable or Metastatic Conditions

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study on the Safety and Tolerability of Spartalizumab for Patients with Advanced Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Hungary Italy +2

  • Study on the Safety and Effectiveness of Amivantamab and Capmatinib for Patients with Unresectable Metastatic Non-Small Cell Lung Cancer

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland 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

  • 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 includes subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.
  • MET exon 14 skipping mutation: A genetic alteration in the MET gene that leads to the skipping of exon 14 during RNA splicing, resulting in a modified MET protein that promotes cancer growth and survival.
  • MET amplification: An increase in the number of copies of the MET gene, which can lead to overexpression of the MET protein and contribute to cancer development and progression.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment, typically including both complete and partial responses.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Duration of response (DOR): The length of time from the initial tumor response to disease progression in patients who achieve a complete or partial response to treatment.
  • Disease control rate (DCR): The percentage of patients who achieve complete response, partial response, or stable disease with treatment.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standardized set of rules used to assess tumor response to treatment in cancer clinical trials.

References

  1. https://clinicaltrials.gov/study/NCT02414139
  2. https://clinicaltrials.gov/study/NCT02750215
  3. https://clinicaltrials.gov/study/NCT04677595
  4. https://clinicaltrials.gov/study/NCT03693339
  5. https://clinicaltrials.gov/study/NCT04139317
  6. https://clinicaltrials.gov/study/NCT05567055
  7. https://clinicaltrials.gov/study/NCT04926831
  8. https://clinicaltrials.gov/study/NCT05675683