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Ongoing Clinical Trials for EGFR Gene Mutation

Five clinical trials are currently investigating new treatments for patients with cancers involving EGFR gene mutations, primarily focusing on advanced non-small cell lung cancer. These studies are being conducted across multiple European countries and examine various targeted therapies and combination treatments. The trials aim to improve treatment outcomes for patients whose cancer has specific genetic changes that affect how their disease progresses and responds to therapy.

Clinical trial locations

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

This trial examines a combination treatment for patients with advanced non-small cell lung cancer that has a specific mutation in the EGFR gene. The study focuses on patients whose cancer has continued to grow despite previous treatment with third-generation EGFR inhibitors such as osimertinib or lazertinib.

Main inclusion criteria: Participants must be at least 18 years old and have a confirmed diagnosis of non-squamous non-small cell lung cancer at stage IIIB/C or IV, meaning the cancer is advanced. The cancer must have specific EGFR mutations, including exon 19 deletion or L858R mutation, confirmed by a certified laboratory. Patients must have experienced disease progression during treatment with osimertinib or lazertinib, which they must have stopped at least 8 days before joining the study. They should have previously benefited from these medications, showing a response or stable disease for at least 6 months. The cancer must be measurable using standard criteria, and patients must have adequate blood, kidney, and liver function.

Main exclusion criteria: Patients without the specific EGFR mutation in advanced non-squamous lung cancer cannot participate. Those who have not received prior treatment with third-generation EGFR inhibitors or whose cancer has not progressed after such treatment are not eligible. Patients outside the specified age range or those unable to provide informed consent are also excluded.

Focus of the trial: The study evaluates how effective the combination of amivantamab, lazertinib, and bevacizumab is in managing the disease after progression on standard treatments. Researchers will assess the objective response rate after 12 weeks of treatment, monitoring how well the cancer responds. The trial also examines the safety of using these medications together and tracks patients’ overall health throughout the study period.

Investigational drugs: Amivantamab targets and blocks certain proteins on cancer cells that help them grow. Lazertinib inhibits the activity of proteins involved in cancer cell growth and spread. Bevacizumab prevents the growth of new blood vessels that tumors need to survive. Lazertinib is taken as a tablet, while amivantamab and bevacizumab are given as infusions directly into the bloodstream.

Study on Patritumab Deruxtecan and Zirconium (89Zr) Patritumab Deruxtecan for Patients with Advanced EGFR Mutation Positive Lung Cancer

This trial is investigating patritumab deruxtecan, a special type of antibody-based medicine, for treating advanced non-small cell lung cancer with EGFR mutations. The study uses a radioactively labeled version of the medication to help doctors visualize how the treatment works inside the body.

Main inclusion criteria: Participants must provide informed consent and a tumor tissue sample for analysis. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 7 months after the last dose. Men must also agree to use birth control for at least 4 months after treatment. Patients must have confirmed advanced stage EGFR mutation positive lung cancer that cannot be cured with surgery. The cancer must be measurable according to standard criteria, with at least two lesions that are 2 cm or larger. Patients must have received at least one previous treatment with an EGFR inhibitor, and if their tumor has the T790M mutation, they must have been treated with a third-generation EGFR inhibitor. Participants must be at least 18 years old and have adequate bone marrow and organ function.

Main exclusion criteria: Patients without a positive EGFR mutation test or those outside the specified age range cannot participate. Those unable to undergo the required imaging or with other medical conditions that might interfere with the study are not eligible.

Focus of the trial: The study aims to find the best dose of non-radioactive patritumab deruxtecan to use alongside the radioactive version for imaging. Doctors use PET/CT scans to see how the medicine is distributed in the body and how much is taken up by tumors. This information helps researchers understand how the treatment is working and could improve future treatment approaches.

Investigational drugs: Patritumab deruxtecan is a monoclonal antibody that targets specific proteins in cancer cells. The radioactively labeled version allows doctors to track the medication using imaging techniques. Both forms are given as infusions through a vein.

Study on the Effectiveness and Safety of BAY 2927088 Compared to Standard Treatment in Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations

This trial tests a new oral medication called BAY 2927088 for treating advanced non-small cell lung cancer with HER2 mutations, comparing it to standard chemotherapy and immunotherapy combinations.

Main inclusion criteria: Participants must be at least 18 years old and have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer that cannot be treated with surgery or has spread to other parts of the body. The cancer must have a specific activating HER2 mutation in the tyrosine kinase domain, confirmed by laboratory testing. Patients must not have received any previous systemic treatment for advanced or metastatic disease. Previous treatment given after or before surgery must have been completed at least 12 months before joining the study. Participants must be eligible to receive standard chemotherapy treatment with cisplatin or carboplatin plus pemetrexed, along with pembrolizumab.

Main exclusion criteria: Patients without advanced non-small cell lung cancer with a HER2 mutation cannot participate. Those outside the specified age range or considered part of vulnerable populations requiring special protection are not eligible.

Focus of the trial: The study evaluates whether BAY 2927088 can help patients live longer without their cancer worsening compared to standard treatments. Participants are randomly assigned to receive either the new tablet medication or standard intravenous chemotherapy and immunotherapy. Researchers monitor how the cancer responds to treatment and track any side effects throughout the study period.

Investigational drugs: BAY 2927088 is a tyrosine kinase inhibitor taken orally that targets the HER2 protein involved in cancer cell growth. Standard treatment includes pembrolizumab, pemetrexed, and either cisplatin or carboplatin, all given as infusions.

Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

This trial investigates BAY 2927088 for various types of advanced solid tumors beyond lung cancer that have HER2 mutations, including colorectal, biliary tract, bladder, cervical, and endometrial cancers.

Main inclusion criteria: Patients must be at least 18 years old and have advanced solid tumors that cannot be removed by surgery, including colorectal, biliary tract, bladder and urinary tract, cervical, endometrial, and other solid tumors (excluding lung cancer). They must have already tried standard treatments or have no satisfactory alternative options. The cancer must have a confirmed activating HER2 mutation, and patients must have at least one tumor area that can be measured and tracked during the study using standard criteria.

Main exclusion criteria: Patients with cancer types not classified as advanced solid tumors or those without a HER2 mutation cannot participate. Patients unwilling or unable to follow study procedures, those who are pregnant or breastfeeding, or those with certain medical conditions or allergies that could interfere with the study are not eligible. Recent participation in another clinical trial may also affect eligibility.

Focus of the trial: The study examines how well BAY 2927088 works in reducing tumor size or stopping tumor growth in various types of advanced cancers with HER2 mutations. Researchers monitor the objective response rate, which measures how tumors respond to treatment, as well as the duration of response and time to response. Safety assessments track any side effects, and quality of life is evaluated throughout the trial period, which extends up to 36 months.

Investigational drugs: BAY 2927088 is an oral tyrosine kinase inhibitor that blocks specific proteins involved in cancer cell growth and spread. It specifically targets tumors with HER2-activating mutations.

Study of Osimertinib for Patients with EGFR-Mutated Non-Small Cell Lung Cancer

This trial evaluates osimertinib as a first-line treatment for patients with non-small cell lung cancer that has specific EGFR gene mutations. The study uses osimertinib as the initial therapy, meaning it is given to patients who have not yet received other treatments for their advanced cancer.

Main inclusion criteria: Participants must provide written informed consent and be older than 18 years. They need a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer that cannot be cured with surgery or radiation. The cancer must have confirmed EGFR mutations in specific parts of the gene, excluding certain changes in exon 20. Patients’ ability to perform daily activities must be measured at a certain level on the ECOG scale (0-2), and they should have a life expectancy of at least 12 weeks. Patients with brain metastases can participate if the metastases are mild to moderately symptomatic or have been treated and are stable. At least one tumor area must be measurable and not previously treated with radiation. Women of childbearing potential must use effective birth control, have a negative pregnancy test, and not be breastfeeding. Men must agree to use barrier contraception.

Main exclusion criteria: Patients without EGFR-mutated non-small cell lung cancer or those outside the specified age range cannot participate. Vulnerable populations requiring special protection are not eligible for this study.

Focus of the trial: The study evaluates how effective osimertinib is as a first-line treatment by measuring the objective response rate, which shows how well the cancer responds. Researchers also track progression-free survival, duration of response, and overall survival. Regular monitoring includes physical examinations, imaging tests, and laboratory analyses to assess treatment effectiveness and any side effects.

Investigational drugs: Osimertinib is taken as a tablet and works by blocking the activity of mutated EGFR proteins that are responsible for cancer cell growth and spread. It is administered daily at doses of either 40 mg or 80 mg, depending on the treatment plan.

Summary

These five clinical trials reflect a concentrated research effort in treating cancers with specific gene mutations, particularly in advanced non-small cell lung cancer. The studies span 21 European countries, with the largest trial examining BAY 2927088 for HER2-mutated lung cancer being conducted across 18 countries including France, Italy, Spain, Germany, and the Netherlands.

A notable focus is on developing targeted therapies that address cancer progression after standard treatments have stopped working. Several trials examine combination approaches, such as the three-drug regimen of amivantamab, lazertinib, and bevacizumab for patients who have progressed on earlier EGFR inhibitors. This reflects an understanding that cancer can develop resistance to initial treatments.

The trials also demonstrate innovation in using imaging techniques with radioactively labeled medications, as seen in the patritumab deruxtecan study conducted in the Netherlands. This approach helps researchers visualize how treatments work inside the body.

Two trials focus on BAY 2927088, investigating this medication both specifically for lung cancer with HER2 mutations and more broadly for various advanced solid tumors with similar genetic changes. This suggests researchers are exploring whether treatments effective for one cancer type might benefit others with similar molecular characteristics.

The studies include both first-line treatments for newly diagnosed patients and options for those whose cancer has progressed, addressing different stages of the treatment journey. All trials emphasize careful monitoring of both effectiveness and safety, with comprehensive eligibility criteria ensuring patient safety throughout participation.

Ongoing Clinical Trials on EGFR gene mutation

  • Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

    Recruiting

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

  • Study on the Effectiveness and Safety of BAY 2927088 Compared to Standard Treatment in Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark Finland +12

  • Study on Patritumab Deruxtecan and Zirconium (89Zr) Patritumab Deruxtecan for Patients with Advanced EGFR Mutation Positive Lung Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Osimertinib for Patients with EGFR-Mutated Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Lithuania Norway Sweden

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