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 study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Technische Universitaet Dresden	Dresden	Germany
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Hopital Ambroise Pare	Boulogne-Billancourt	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Klinikum Kassel GmbH	Kassel	Germany
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
MD Anderson Cancer Center	Madrid	Spain
Micancer Center S.L.P.	Barcelona	Spain
Centre Hospitalier Universitaire De Nantes	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Ixvjdfgo Rllbiyxnf Pis Lm Segetm Djg Tghblt Dgco Actaxyg Iamb Srbexq	Meldola	Italy
Iikduixj Cdftli Dbctlabozixwvhjev	L'hospitalet De Llobregat	Spain
Clqmgp Hziydudqlhc Ee Uyhvzvauxhstf Dy Lcklvav	Limoges	France
Akvzuwmqos Pzfpybnk Hzxzoypp Dp Mglsthnuo	Marseille	France
Hklsnnlf Dl Li Srxvs Cmup I Spbo Pse	Barcelona	Spain
Altsbsa Oyoemxqjmhy Upojkywhtheim Popue	Parma	Italy
Cwcwkm Lzqq Bcuchn	Lyon	France
Ffmwbfqvy Pzzd Lq Izixorlvuvbcq Bhrbqrwkw Dwp Hspuaywl Utrgvctzoivbv Lw Png	Madrid	Spain
Hinwfiin Uarkyazzxuyor dm A Cnvxqn	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.10.2023
Germany	Recruiting	31.10.2023
Italy	Recruiting	31.10.2023
Spain	Recruiting	31.10.2023

Trial locations

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.

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.

Trial ID:

2023-503865-48-00

Protocol code:

TAS6417-201

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?