Study of Zipalertinib with Chemotherapy vs. Chemotherapy Alone for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion 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) that has specific changes in the Epidermal Growth Factor Receptor (EGFR) gene, called Exon 20 insertion mutations. The study is investigating the effectiveness and safety of a new treatment approach that combines a medication called Zipalertinib with chemotherapy, compared to chemotherapy alone. Chemotherapy in this study includes drugs like Pemetrexed, Carboplatin, and Cisplatin, which are commonly used to treat various cancers.

The purpose of the study is to determine if adding Zipalertinib to the chemotherapy regimen can improve outcomes for patients who have not received prior treatment for their advanced or metastatic NSCLC. The study is divided into two parts. In the first part, researchers aim to find the best dose of Zipalertinib when used with chemotherapy. In the second part, they will compare how long patients live without their cancer getting worse between those receiving the combination treatment and those receiving only chemotherapy.

Participants in the study will receive treatment over a period of time, with regular monitoring to assess the effects of the treatment. The study will help to understand if the combination of Zipalertinib and chemotherapy offers a better treatment option for patients with this specific type of lung cancer. The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study aims to provide valuable information that could lead to improved treatment strategies for patients with advanced NSCLC.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving zipalertinib with chemotherapy, and the other receiving chemotherapy alone.

The study focuses on patients with advanced non-small cell lung cancer with specific genetic mutations.

2 treatment administration

Patients in the zipalertinib group will take zipalertinib orally in tablet form. The dosage and frequency will be determined during the study.

All patients will receive chemotherapy, which includes pemetrexed and a platinum agent such as carboplatin or cisplatin. These medications are administered intravenously as a solution for infusion.

3 treatment cycles

The treatment is given in cycles. Each cycle’s duration and the number of cycles will be specified during the study.

Patients will be monitored for any side effects and the effectiveness of the treatment throughout the cycles.

4 monitoring and assessments

Regular assessments will be conducted to monitor the patient’s health and the progression of the disease.

These assessments may include imaging tests and laboratory evaluations to ensure the treatment is working and to adjust dosages if necessary.

5 end of treatment

The study will continue until the estimated end date in November 2026, or until the patient completes the treatment cycles.

After completing the treatment, follow-up assessments will be conducted to evaluate the long-term effects and outcomes of the treatment.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate in the study after understanding all the details.
Have adequate organ function, which will be checked through lab tests to ensure your organs are working well enough.
Have a life expectancy of at least 3 months, as determined by the doctor conducting the study.
Women who can have children must have a negative pregnancy test before starting the study treatment. Women are not considered able to have children if they have gone through menopause (no periods for 12 months without another reason) or have had surgery to remove reproductive organs.
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 study treatment.
Be at least 18 years old or meet the legal adult age in your country, whichever is older.
Have a confirmed diagnosis of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), which means the cancer has spread beyond the lungs.
Have not received any prior systemic treatment for advanced or metastatic nonsquamous NSCLC. Previous treatment for early-stage NSCLC is allowed if it was more than 6 months before the study treatment. Certain previous treatments with specific drugs are allowed if they meet specific conditions, such as short treatment duration and no response to treatment.
Have documented EGFR mutation status, which means a specific genetic test has been done to check for changes in the EGFR gene.
Have available tumor tissue for testing, which means a sample of the cancer is available to check for specific genetic changes.
If you have brain metastases (cancer spread to the brain), you must have received treatment for them and have stable disease, meaning no new symptoms and no need for steroids for at least 2 weeks before joining the study. Small, symptom-free brain metastases may be allowed if immediate treatment is not needed.
Have at least one measurable lesion, which is a tumor that can be measured to see if it changes during the study. This is required for some parts of the study.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have had previous treatment that might interfere with the study.
Patients with serious health conditions that could make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients who have allergies to the study medications.
Patients who are participating in another clinical trial.
Patients who have had a recent major surgery.
Patients with certain infections that could affect the study.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Medisprof S.R.L.	Cluj Napoca	Romania
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Sigmedical Services S.R.L.	Suceava	Romania
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.	Panagyurishte	Bulgaria
Bioclinic S.A.	Thessaloniki	Greece
Algemeen Ziekenhuis Delta	Roeselare	Belgium
General University Hospital Of Larissa	Larissa	Greece
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Ludwig Maximilian University Of Munich	Munich	Germany
Universita’ Politecnica Delle Marche	Ancona	Italy
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Oncocenter Oncologie Clinica S.R.L.	Timisoara	Romania
General University Hospital Of Patras	Patras	Greece
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Netherlands Cancer Institute	Amsterdam	The Netherlands
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Az Maria Middelares Gent	Gent	Belgium
Hospital Universitario De Jaen	Jaen	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
MD Anderson Cancer Center	Madrid	Spain
Instytut Msf Sp. z o.o.	Lodz	Poland
Micancer Center S.L.P.	Barcelona	Spain
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Area Sanitaria Da Coruna E Cee	A Coruna Galicia	Spain
Metropolitan Hospital	Athens	Greece
Ibtnxjsd Rfpnypgep Pjy Lz Sxaepr Dsp Tykeuy Drcz Agbwlkk Ildd Synhre	Meldola	Italy
Ajsynhdns Uni	Amsterdam	The Netherlands
Ssybvufyj Rhkqeir Umjxahadkh Mprbueh Ckwkuq	Nijmegen	The Netherlands
Ijbwff Iewfdraw Fwxiwwoqhffoc Owspnapwswr	Rome	Italy
Imigrvnl Cbxbcj Dhhcmsoenebonbuhy	L'hospitalet De Llobregat	Spain
Ldbjn Gjuqafp Htpdtpia Oq Aaskgg	Athens	Greece
Cwxlxg Hzvjvmpvnaq Ea Uyuataivrkoky Do Lwufqti	Limoges	France
Acolwzu Ohnbjromcqz Nxydbgtrl Su Ahqwnph E Bvibiu E C Adnjrs Amcusnslwhv	Alexandria	Italy
Hlqtquie Df Lv Sfhmz Cncj I Sywf Pnz	Barcelona	Spain
Fsoknofpb Peks Lf Imvzbhnrrmlie Bmvuqpuvs Dhj Hokhprgm Uuruijhstrhto Lf Poy	Madrid	Spain
Ivyjwtpy Cqaqm	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.11.2023
Bulgaria	Not recruiting	01.11.2023
France	Not recruiting	01.11.2023
Germany	Not recruiting	01.11.2023
Greece	Not recruiting	01.11.2023
Italy	Not recruiting	01.11.2023
Poland	Not recruiting	01.11.2023
Romania	Not recruiting	01.11.2023
Spain	Not recruiting	01.11.2023
The Netherlands	Not recruiting	01.11.2023

Trial locations

Investigated drugs:

Zipalertinib is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer. It is used in combination with chemotherapy to see if it can help slow down the progression of the disease. This medication targets a mutation in the cancer cells, which may help stop them from growing.

Pemetrexed is a chemotherapy drug used in this trial. It works by interfering with the growth of cancer cells, slowing or stopping their spread. It is often used to treat certain types of lung cancer and is being tested in combination with other treatments to see if it improves patient outcomes.

Platinum Agent refers to a group of chemotherapy drugs that contain platinum. These drugs are used to damage the DNA of cancer cells, which can lead to their death. In this trial, a platinum agent is combined with other treatments to evaluate its effectiveness in treating lung cancer.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by specific genetic changes known as EGFR exon 20 insertion mutations. These mutations affect the epidermal growth factor receptor (EGFR), which plays a role in cell growth and division. The presence of these mutations can lead to uncontrolled cell growth, contributing to the development and progression of cancer. Non-small cell lung cancer is the most common type of lung cancer, and the presence of EGFR mutations can influence how the disease behaves. The progression of this cancer can vary, with some cases growing slowly while others may advance more rapidly. Understanding the specific genetic mutations involved is crucial for determining the most effective treatment strategies.

Trial ID:

2023-503575-21-00

Protocol code:

TAS6417-301

NCT ID:

NCT05973773

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Zipalertinib with Chemotherapy vs. Chemotherapy Alone for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?