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Lazertinib

Lazertinib is an oral third-generation tyrosine kinase inhibitor (TKI) being studied in clinical trials for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations. This article summarizes key information about ongoing clinical trials evaluating Lazertinib’s efficacy, safety, and potential as a treatment option for patients with EGFR-mutant NSCLC.

Table of Contents

What is Lazertinib?

Lazertinib is a new type of medication designed to treat certain forms of lung cancer. It is also known by other names such as JNJ-73841937 and YH25448[3]. Lazertinib belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), specifically a third-generation EGFR-TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor)[1].

How Does Lazertinib Work?

Lazertinib works by targeting specific mutations in the EGFR gene that are found in some lung cancer cells. It is designed to selectively inhibit EGFR-TKI sensitizing mutations, particularly those known as exon 19 deletion or exon 21 L858R[1]. By blocking these mutated receptors, Lazertinib can help slow down or stop the growth of cancer cells.

One of the notable features of Lazertinib is its effectiveness in patients with central nervous system (CNS) metastases, which means it can potentially treat lung cancer that has spread to the brain[1].

What Conditions Does Lazertinib Treat?

Lazertinib is primarily used to treat Non-Small Cell Lung Cancer (NSCLC) that has specific EGFR mutations. It is particularly useful for patients who have:

  • Advanced or metastatic NSCLC with EGFR mutations (exon 19 deletion or exon 21 L858R)[1]
  • NSCLC that has progressed after treatment with first- or second-generation EGFR-TKIs[4]
  • NSCLC with T790M mutation, which often develops as a resistance mechanism to earlier generations of EGFR-TKIs[4]

Dosage and Administration

Lazertinib is typically taken orally as a tablet. The most common dosage studied in clinical trials is 240 mg once daily[2]. However, some studies are exploring lower doses, such as 160 mg daily, to evaluate if they can provide similar benefits with potentially fewer side effects[4].

It’s important to note that the medication should be taken at approximately the same time each day, usually before eating a meal and in a fasting state[5]. If a dose is missed by more than 12 hours, patients are typically advised to skip that dose and take the next one at the regular scheduled time.

Ongoing Clinical Trials

Lazertinib is being studied in various clinical trials to better understand its effectiveness and safety. Some of the ongoing research includes:

  • Evaluating Lazertinib as a consolidation therapy after chemoradiation for locally advanced, unresectable NSCLC[2]
  • Studying the combination of Lazertinib with chemotherapy for patients who don’t show complete response to Lazertinib alone[1]
  • Investigating Lazertinib’s effectiveness in NSCLC with uncommon EGFR mutations[5]
  • Exploring Lazertinib as a neoadjuvant therapy (treatment given before surgery) for resectable NSCLC[6]

Potential Side Effects

As with all medications, Lazertinib may cause side effects. While specific side effect profiles are still being studied in ongoing trials, common side effects of EGFR-TKIs can include:

  • Skin rashes or dryness
  • Diarrhea
  • Fatigue
  • Loss of appetite
  • Nausea

Clinical trials are carefully monitoring for adverse events and evaluating the safety profile of Lazertinib[6]. It’s important for patients to report any unusual symptoms or side effects to their healthcare provider.

Future Research and Developments

Research on Lazertinib is ongoing, with several areas of focus:

  • Comparing different formulations of Lazertinib to improve its effectiveness or ease of use[7]
  • Studying how liver function affects the way Lazertinib is processed in the body[3]
  • Investigating Lazertinib in combination with other cancer treatments to potentially improve outcomes[1]
  • Evaluating Lazertinib’s effectiveness in earlier stages of lung cancer or as a preventive treatment after surgery[6]

As research progresses, we may learn more about how to best use Lazertinib to help patients with NSCLC and potentially other types of cancer.

Aspect Details
Drug Name Lazertinib (also known as JNJ-73841937, YH25448)
Drug Class Third-generation tyrosine kinase inhibitor (TKI)
Target EGFR mutations (including exon 19 deletion, exon 21 L858R, and T790M)
Indication Non-small cell lung cancer (NSCLC) with EGFR mutations
Administration Oral, once daily (common dose: 240 mg)
Clinical Trial Phases Phase 1, Phase 2
Study Settings First-line treatment, after progression on previous EGFR-TKIs, combination with chemotherapy, neoadjuvant therapy
Key Outcomes Measured Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), safety profile
Special Populations Patients with brain metastases, uncommon EGFR mutations, hepatic impairment
Ongoing Research Optimal dosing, biomarkers for treatment response, combination therapies, use in early-stage disease

FAQ

  • What is Lazertinib? Lazertinib is an oral third-generation tyrosine kinase inhibitor (TKI) that selectively inhibits EGFR-TKI sensitizing mutations in non-small cell lung cancer (NSCLC). It is being studied as a treatment option for patients with EGFR-mutant NSCLC.
  • What types of NSCLC is Lazertinib being studied for? Lazertinib is being studied for NSCLC with EGFR mutations, including common mutations like exon 19 deletion and exon 21 L858R, as well as the T790M resistance mutation. Some trials are also looking at its efficacy in patients with uncommon EGFR mutations.
  • How is Lazertinib administered? Lazertinib is typically administered orally once daily. The most common dose being studied is 240 mg per day, though some trials are also evaluating lower doses like 160 mg daily.
  • What are some of the potential benefits of Lazertinib? Clinical trials suggest Lazertinib may be effective in treating EGFR-mutant NSCLC, including in patients with brain metastases. It is being studied as both a monotherapy and in combination with other treatments like chemotherapy. Some trials are evaluating its use as a first-line treatment, while others are looking at its efficacy in patients who have progressed on previous EGFR-TKIs.
  • What are researchers trying to learn about Lazertinib in current clinical trials? Current clinical trials are evaluating Lazertinib's efficacy, safety, and optimal dosing. Researchers are studying its use in various settings, including as a first-line treatment, in combination with other therapies, and in specific patient populations like those with brain metastases or uncommon EGFR mutations. Some trials are also looking at biomarkers that may predict response to treatment.

Ongoing Clinical Trials on Lazertinib

  • A Study of Amivantamab and Lazertinib for Adults with EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Finland France Germany Greece Italy +3

  • Study of Amivantamab, Lazertinib, and Pemetrexed for Patients with Advanced or Metastatic Solid Tumors, Including EGFR-Mutated Non-Small Cell Lung Cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    France Germany Italy Spain

  • A study to evaluate how lazertinib is absorbed in healthy adults to support future treatment for non-small cell lung cancer.

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study Comparing Lazertinib and Subcutaneous Amivantamab with Intravenous Amivantamab for Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer

    Not recruiting

    3 1 1
    Investigated drugs:
    France Germany Italy Poland Portugal Spain

  • Study on the Effectiveness and Safety of Lazertinib and Gefitinib for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary

  • Study on Amivantamab, Lazertinib, and Bevacizumab for Patients with Advanced EGFR-Mutant Non-Small Cell Lung Cancer After Treatment Progression

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy The Netherlands Spain

  • Study on Methotrexate, Dexamethasone, and Montelukast to Prevent Infusion Reactions in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • Study of Amivantamab, Lazertinib, and Drug Combination for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer After Osimertinib Failure

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +6

  • Study on Skin Care for Patients with Advanced EGFR-Mutated Lung Cancer Treated with Amivantamab and Lazertinib

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study of Amivantamab and Lazertinib Combination vs. Osimertinib vs. Lazertinib for First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +3

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, which can be targeted by specific drugs.
  • Tyrosine Kinase Inhibitor (TKI): A type of targeted therapy that blocks specific enzymes called tyrosine kinases, which are involved in cell signaling, growth, and division. In NSCLC, TKIs are used to target mutated EGFR proteins.
  • Non-Small Cell Lung Cancer (NSCLC): The most common type of lung cancer, accounting for about 80-85% of all cases. It includes subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse. This is often used as a measure of treatment effectiveness in clinical trials.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive. This is an important measure of the effectiveness of cancer treatments.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It includes patients with complete response (CR) and partial response (PR).
  • Disease Control Rate (DCR): The percentage of patients who have a complete response, partial response, or stable disease in response to treatment.
  • Circulating Tumor DNA (ctDNA): Small fragments of DNA released by tumor cells into the bloodstream. Analyzing ctDNA can provide information about the genetic makeup of a tumor and help monitor treatment response.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment or procedure, whether or not it is considered related to the treatment.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Biomarkers can be used to see how well the body responds to a treatment for a disease or condition.

References

  1. https://clinicaltrials.gov/study/NCT06020989
  2. https://clinicaltrials.gov/study/NCT05338619
  3. https://clinicaltrials.gov/study/NCT05112952
  4. https://clinicaltrials.gov/study/NCT05701384
  5. https://clinicaltrials.gov/study/NCT05277701
  6. https://clinicaltrials.gov/study/NCT06268210
  7. https://clinicaltrials.gov/study/NCT05162274