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Study on the Safety and Effectiveness of Zipalertinib for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with Specific EGFR Mutations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). Specifically, it looks at cases where the cancer is locally advanced or has spread to other parts of the body, and involves certain genetic changes called Exon 20 Insertion and other uncommon mutations in a protein known as the Epidermal Growth Factor Receptor (EGFR). The trial is testing a medication called Zipalertinib, also known by its code name TAS6417 or CLN-081, which is taken as a tablet by mouth.

The purpose of the study is to evaluate how well Zipalertinib works in treating patients with these specific types of lung cancer mutations. Participants in the study will receive the medication and be monitored for their response to the treatment. The study will also look at the safety of the medication and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Zipalertinib.

The study will take place over a period of time, with participants receiving the medication and undergoing regular check-ups to assess their health and the progress of their cancer. The trial aims to gather information on how effective Zipalertinib is in controlling the cancer and improving the quality of life for patients with these specific genetic changes in their lung cancer. The study is expected to continue until mid-2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will provide written informed consent, confirming understanding and agreement to participate.
The patient must be at least 18 years old and have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility, which includes a review of medical history and current health status.
Tests will be conducted to confirm the presence of specific genetic mutations and to assess the stability of any brain metastases.
Step 3
Treatment initiation
The patient will begin treatment with zipalertinib, administered orally in tablet form.
The dosage and frequency will be determined by the study protocol and the patient's specific health needs.
Step 4
Ongoing monitoring
Throughout the study, the patient will have regular check-ups to monitor health status and response to treatment.
These check-ups will include clinical laboratory tests, vital signs assessments, and imaging studies to evaluate the cancer's response to treatment.
Step 5
Evaluation of response
The patient's response to zipalertinib will be evaluated using criteria that measure tumor size and progression.
The primary goal is to assess the objective response rate, which is the proportion of patients experiencing a significant reduction in tumor size.
Step 6
Completion of study
The study is expected to continue until June 2025, with the patient's participation lasting as long as the treatment is beneficial and safe.
Upon completion, the patient's overall health and treatment outcomes will be reviewed.

Who can join the trial?

10 criteria

Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Be at least 18 years old or meet the legal adult age in your country.
Have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic changes called **EGFR ex20ins mutations** or other uncommon **EGFR mutations**.
For patients with brain metastasis (cancer spread to the brain), you must be neurologically stable, meaning your condition is not worsening, and you have received treatment for the brain metastasis.
Have measurable disease according to a standard called **RECIST 1.1**, which is a way to measure how cancer responds to treatment.
Have available tumor tissue samples for testing specific genetic changes and other markers.
Have a good performance status, which means you are able to carry out daily activities with little or no assistance, as measured by the **ECOG Performance Status** scale (0 or 1).
Have adequate organ function, which means your blood and organ tests meet specific health standards.
Women who can have children must have a negative pregnancy test before starting the study treatment.
Both men and women who can have children must agree to use effective birth control during the study and for 6 months after the last dose of the study treatment.

Who cannot join the trial?

6 criteria

Patients who do not have locally advanced or metastatic non-small cell lung cancer. This means the cancer has not spread to nearby areas or other parts of the body.
Patients without specific genetic changes in their cancer, known as EGFR ex20ins mutations or other uncommon EGFR mutations. These are specific changes in the cancer cells that affect how they grow.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population. This refers to groups who may need special protection or care.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Zipalertinib is a medication being studied for its effectiveness and safety in treating patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This trial focuses on patients whose cancer has certain genetic mutations, specifically those involving the epidermal growth factor receptor (EGFR). The goal is to see how well zipalertinib works in shrinking or controlling the cancer in these patients.

What is already known about the treatment

Zipalertinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that have specific genetic mutations. It is in the investigational stage, with ongoing research to determine its potential benefits and risks. The main therapeutic indication for zipalertinib is NSCLC with exon 20 insertion mutations or other uncommon epidermal growth factor receptor (EGFR) mutations. At the molecular level, zipalertinib works by inhibiting the activity of the EGFR, which is often overactive in certain types of cancer cells, thereby slowing down or stopping their growth. It is classified pharmacologically as a tyrosine kinase inhibitor.

Investigated diseases

Locally Advanced or Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its spread beyond the original site. In its locally advanced stage, the cancer has spread to nearby tissues or lymph nodes. When it becomes metastatic, it has spread to other parts of the body, such as the bones or brain. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with lung function and other bodily processes. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary, with some patients experiencing rapid advancement while others may have a slower course.