Study Comparing Patritumab Deruxtecan and Platinum-based Chemotherapy for Patients with Advanced EGFR-mutated Non-small Cell Lung Cancer After EGFR Therapy Failure

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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. The study is comparing the effects of a new treatment called Patritumab Deruxtecan (also known by its code name U3-1402 or HER3-DXd) with standard chemotherapy treatments that use platinum-based drugs. These standard treatments include medications like Pemetrexed, Carboplatin, and Cisplatin. The purpose of the study is to see how well these treatments work in patients whose cancer has spread to other parts of the body or is locally advanced and has not responded to previous treatments targeting the EGFR gene.

Participants in the study will receive either the new treatment or one of the standard chemotherapy options. The new treatment, Patritumab Deruxtecan, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The study will last for a period of up to 36 months, during which the effects of the treatments will be monitored. The main goal is to determine how long the cancer can be controlled without getting worse, which is known as progression-free survival. Other aspects, such as overall survival and the response of the cancer to the treatment, will also be evaluated.

This study is important for understanding how effective Patritumab Deruxtecan is compared to existing chemotherapy options for patients with EGFR-mutated NSCLC. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for this type of lung cancer in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive patritumab deruxtecan, and the other group will receive platinum-based chemotherapy.

You will be informed about which treatment you will receive, as this is an open-label study.

2 treatment with patritumab deruxtecan

If you are assigned to the patritumab deruxtecan group, you will receive this medication through an intravenous infusion. This means the medication will be given directly into your vein.

The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.

3 treatment with platinum-based chemotherapy

If you are assigned to the platinum-based chemotherapy group, you will receive one of the following medications: pemetrexed, carboplatin, or cisplatin. These medications will also be administered through an intravenous infusion.

The specific medication, dosage, and frequency will be determined by the study protocol and your healthcare provider.

4 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests to assess the progress of your treatment.

You will be asked to report any side effects or changes in your health to your healthcare provider.

5 end of treatment

At the end of the treatment period, you will have a final assessment to evaluate the effects of the treatment.

You may be asked to continue follow-up visits to monitor your health and gather additional information for the study.

Who Can Join the Study?

Sign and date the main informed consent form before starting any study-specific procedures.
Be willing to provide a sufficient amount and quality of tumor tissue.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how a disease affects a patient’s daily living abilities, where 0 means fully active and 1 means restricted in physically strenuous activity but able to carry out light work.
Have adequate bone marrow reserve and organ function based on recent laboratory tests.
If female and capable of having children, must have a negative pregnancy test and agree to use highly effective birth control during the study and for 7 months after the last dose of the study drug.
Female participants must not donate or retrieve eggs for personal use during the study and for at least 7 months after the last dose of the study drug.
If male, must be surgically sterile or agree to use highly effective birth control during the study and for at least 4 months after the last dose of the study drug.
Male participants must not freeze or donate sperm during the study and for at least 4 months after the last dose of the study drug.
Be at least 18 years old.
Have a confirmed diagnosis of metastatic or locally advanced nonsquamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
Have a documented EGFR-activating mutation in the tumor, which is a specific change in the cancer cells that can be detected from a tumor sample or blood test.
Have received 1 or 2 prior treatments with approved EGFR TKI drugs, which are targeted therapies for this type of cancer, including a third-generation EGFR TKI like osimertinib.
May have received previous treatments before the cancer spread, as long as the cancer progressed at least 12 months after the last dose of such therapy and after receiving a third-generation EGFR TKI for metastatic or locally advanced disease.
Have not received any other prior systemic therapies (like chemotherapy or immunotherapy) for metastatic or locally advanced cancer.
Have documented disease progression while receiving or after a third-generation EGFR TKI for metastatic or locally advanced disease.
Have at least one measurable lesion, which is a tumor that can be accurately measured in size.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied cannot participate.
Patients who have not been diagnosed with EGFR-mutated Non-small Cell Lung Cancer (NSCLC) cannot participate. EGFR stands for Epidermal Growth Factor Receptor, which is a protein that can affect the growth of cancer cells.
Patients who have not experienced a specific change in their EGFR gene, known as an exon 19 deletion or L858R mutation, cannot participate. These are specific genetic changes that can affect how cancer grows.
Patients who have not been diagnosed with metastatic or locally advanced cancer cannot participate. Metastatic means the cancer has spread to other parts of the body, and locally advanced means the cancer has grown but not spread to distant parts.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which may include those unable to give consent or those with certain health conditions, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Institut Gustave Roussy	Villejuif	France
Oslo Universitetssykehus HF	Oslo	Norway
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Asklepios Klinik Gauting GmbH	Gauting	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
MD Anderson Cancer Center	Madrid	Spain
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Med Polonia Sp. z o.o.	Poznan	Poland
Hospital Universitario Virgen Macarena	Sevilla	Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Centre Francois Baclesse	Caen	France
Institut fuer Klinische Krebsforschung IKF GmbH	Frankfurt	Germany
Lungenfachklinik Immenhausen	Immenhausen	Germany
Czcxmfuth Uhxncrheucisoo Serlljkgu	Woluwe-Saint-Lambert	Belgium
Ifqvgasp Rwxjtpmp Dv Cwiftm Dk Mdiacluqkaa	Montpellier	France
Aahgrws Ohlxfpivdsi Urqwuteedehmo Prwri	Parma	Italy
Coahif Lwae Bzmtwx	Lyon	France
Uairoohhompbooixsxkeg Eenlr Abd	Essen	Germany
Rldmjiigs Zmfcbvpljg Soqtjwkds	Arnhem	The Netherlands
Hfgynxyq Uwnbjgwefhedc Movjfhd Du Vqonijrnfe	Santander	Spain
Etkofit	Mechelen	Belgium
Haohlend Utpexhmxdmucn Rjglheph Dv Makbqb	Malaga	Spain
Aiikijw Ups Twqwmmm ntkr odmzz	Leghorn	Italy
Ltzeo Uqwzkzyomijf Mmfeenj Cmusueo (pygbh	Leiden	The Netherlands
Hpuzhllz Ufappntmuufni dd A Cfbchh	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	14.09.2022
Belgium	Not recruiting	14.09.2022
France	Not recruiting	14.09.2022
Germany	Not recruiting	14.09.2022
Italy	Not recruiting	14.09.2022
Norway	Not recruiting	14.09.2022
Poland	Not recruiting	14.09.2022
Portugal	Not recruiting	14.09.2022
Spain	Not recruiting	14.09.2022
The Netherlands	Not recruiting	14.09.2022

Trial locations

Investigated drugs:

Patritumab Deruxtecan is a medication being studied for its potential to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that has specific genetic changes called EGFR mutations. This medication is designed to target and attach to cancer cells, delivering a powerful drug directly to them to help stop their growth and spread. It is being compared to standard chemotherapy treatments to see if it can help patients live longer without their cancer getting worse.

Platinum-based Chemotherapy is a common treatment for various types of cancer, including lung cancer. It uses drugs that contain the metal platinum to damage the DNA of cancer cells, which can stop them from growing and dividing. In this study, platinum-based chemotherapy is used as a comparison to see how well the new medication, Patritumab Deruxtecan, works in treating lung cancer with EGFR mutations.

Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated Non-small Cell Lung Cancer – This type of lung cancer is characterized by mutations in the epidermal growth factor receptor (EGFR) gene, which leads to uncontrolled cell growth. It primarily affects the non-squamous cells in the lungs. The disease can either be metastatic, meaning it has spread to other parts of the body, or locally advanced, indicating it has spread extensively within the lungs and nearby areas. The progression involves the continuous growth and spread of cancerous cells, often leading to the formation of tumors. As the disease advances, it can cause symptoms such as persistent cough, shortness of breath, and chest pain. The presence of EGFR mutations often influences the behavior and progression of the cancer.

Trial ID:

2023-507964-38-00

Protocol code:

U31402-A-U301

NCT ID:

NCT05338970

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Patritumab Deruxtecan and Platinum-based Chemotherapy for Patients with Advanced EGFR-mutated Non-small Cell Lung Cancer After EGFR Therapy Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?