Study to Compare Zongertinib with Standard Treatment for Patients with Advanced Non-Small Cell Lung Cancer with HER2 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 the non-squamous subtype. The study is investigating a new treatment called zongertinib (also known by its code name BI 1810631). This treatment is being compared to the current standard treatment for this type of cancer, which includes a combination of medications: pembrolizumab, carboplatin, cisplatin, and pemetrexed. The trial aims to determine if zongertinib is more effective than the standard treatment in patients whose cancer has specific changes in the HER2 gene, known as mutations in the HER2 tyrosine kinase domain.

The purpose of the study is to see if zongertinib can help people with advanced NSCLC that cannot be removed by surgery and has spread to other parts of the body. Participants in the study will receive either zongertinib or the standard treatment, which involves a combination of drugs given through an infusion into a vein. The study will last for several months, and participants will be monitored regularly to see how their cancer responds to the treatment. The main focus is on how long patients live without their cancer getting worse, which is known as progression-free survival.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study will also look at other outcomes, such as the overall response to the treatment and any side effects experienced. This research is important for finding better ways to treat people with advanced non-small cell lung cancer, especially those with specific genetic changes in their cancer cells.

1 joining the study

Upon joining the study, the patient will have signed a consent form, confirming understanding and agreement to participate.

The patient must have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer with specific HER2 mutations.

2 initial assessment

An initial assessment will be conducted to ensure the patient meets all eligibility criteria, including adequate organ function and a life expectancy of at least 12 weeks.

The patient must have at least one measurable lesion as determined by medical imaging.

3 treatment allocation

The patient will be randomly assigned to receive either the new treatment, zongertinib (BI 1810631), or the standard treatment.

Zongertinib is administered orally in the form of film-coated tablets.

4 standard treatment

If assigned to the standard treatment group, the patient will receive a combination of pembrolizumab, platinum-based chemotherapy (either carboplatin or cisplatin), and pemetrexed.

Pembrolizumab is given as an intravenous infusion, typically at a concentration of 25 mg/mL.

Carboplatin or cisplatin, and pemetrexed are also administered intravenously as part of the chemotherapy regimen.

5 treatment duration

The treatment will continue as prescribed by the study protocol, with regular monitoring and assessments to evaluate the patient’s response.

The primary goal is to assess progression-free survival, which means the length of time during and after treatment that the patient lives without the cancer worsening.

6 ongoing assessments

Throughout the trial, the patient will undergo regular assessments to monitor health status and treatment effects.

These assessments include medical imaging and evaluations of any side effects experienced.

7 completion of trial

The trial is expected to continue until June 2028, with ongoing evaluations of treatment effectiveness and safety.

Upon completion, the patient’s overall response and any changes in health status will be reviewed.

Who Can Join the Study?

  • You must sign a written consent form to participate in the trial.
  • Your organs must be working well enough, as defined in the study guidelines.
  • You should have a life expectancy of at least 12 weeks, according to the doctor’s opinion.
  • Both men and women can participate. Women who can have children and men who can father a child must use two reliable methods of birth control.
  • You must be 18 years or older, or the legal age of consent if it’s higher than 18 in your country.
  • You need to have a confirmed diagnosis of advanced or spread non-squamous non-small cell lung cancer.
  • You must have a specific change in the HER2 gene, confirmed by local lab results.
  • A sample of your tumor tissue must be sent to a central lab to confirm the HER2 status. If no sample is available, exceptions can be made with written agreement.
  • You should not have received any treatment for cancer that cannot be removed by surgery, is locally advanced, or has spread, and you should not be eligible for a cure.
  • You must have at least one tumor that can be measured, as determined by a local doctor or radiologist.
  • You should be eligible to receive a specific type of chemotherapy and pembrolizumab, according to the product information.
  • Your Eastern Cooperative Oncology Group (ECOG) score, which measures your ability to perform daily activities, should be 0 or 1.

Who Cannot Join the Study?

  • Patients who have already received any systemic treatment for their lung cancer cannot participate. Systemic treatment refers to medication that travels through the bloodstream to reach and affect cells all over the body.
  • Patients with a type of lung cancer that is not non-squamous non-small cell lung cancer are excluded. Non-squamous means the cancer cells do not have a flat, scale-like shape.
  • Patients without HER2 TKD mutations in their cancer cells are not eligible. HER2 TKD mutations are specific changes in the genes of cancer cells that can affect how the cancer grows.
  • Patients who have had surgery to remove their lung cancer are not eligible. Unresectable means the cancer cannot be removed by surgery.
  • Patients with cancer that is not locally advanced or metastatic are excluded. Locally advanced means the cancer has spread to nearby tissues or lymph nodes, and metastatic means the cancer has spread to other parts of the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Oslo Universitetssykehus HF Oslo Norway
Institut Curie – Site Paris Paris France
Koranyi National Institute For Pulmonology Budapest Hungary

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Universitaetsklinikum Krems Krems An Der Donau Austria
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Hbbyjdy Tobyq Paris France
Ijewmrtw Jnruq Bxjmfi Anderlecht Belgium
Lxvuj Geivhok Hqveblfy Op Akodvq Athens Greece
Hlgfxyjr Vtew dqxgyvet Barcelona Spain
Hprturuk Ugcqfxpoukzcg dz A Crljxq A Coruna Galicia Spain
Vochwz dxo Rsjrt Uhyffmvubn Hwrktafi Sevilla Spain
Upbeokjkuz Hcnfpkhs Cgdjnjc Cologne Germany
Uyteiqmykolwezcxlopye Tyohohfgp Apy Tuebingen Germany
Aoiykcvvpa Pmesuoou Hxoylimo De Mxtmsnyun Marseille France
Jelnkhjdnyxjzxlctbxewebwue Gzdaqlx Giessen Germany
Upiefebnws Hlhbpqon Mzuvpouzrz Maastricht The Netherlands
Cuoksh Hhxzxnsgdiz Uatyandppzlar Dt Rtgtmj Rennes France
Taodczevpmij Hadivtogiy gpkqe Heidelberg Germany
Hrbgeemy Dc Lz Svtxu Cfui I Scok Pqd Barcelona Spain
Cgqjnq Lyzr Bbpasd Lyon France
Utukdixkkk Dzzjd Spwkg Dy Ruay Lh Stemfuky Rome Italy
Ughpvturroak Zefvasgpbi Gbna Gent Belgium
Czvijm Hnrqzymagpa Lsjl Sgv Pierre Benite France
Hvzbknsi Usbrfhuvqbfqp 1a Dt Odmjqnl Madrid Spain
Icjhuuau Czgvan Dplmiatqkwbllieew L'hospitalet De Llobregat Spain
Qejos Smooom Ckpcjggkt Hotgokmo &lnsdre Sgutcjfagsf Uvlnexzkia Hddcvqob &yumaka Vdkxxlm Gpdgvrgjhbwbntuxrp Gothenburg Sweden
Faigkctsa Pagw Lm Iuroudxnlrobi Bzoofzuye Ddw Hexqqmpp Uzqqobuwyvzfc Lu Ptf Madrid Spain
Iajxoxvq Tyulqg Blkc Gelqdcjz Phbaz Ij Bari Italy
Gjmboy Nvlcdewzyv Ttgrjpuwmafqe Gjzzei Puxgixcteopd Thessaloniki Greece
Kkqcxhgaaex Nyvp Kcvzzw Faynwsiiuvv Vienna Austria
Avtvlaz Sinmp Srlxturao Trjgxpebmbng Djv Sthzt Lmbut Varese Italy
Hprqbpbz Cbh Pgwqo Seno Porto Portugal
Htxhemlg Udbdmgmudodjoe Suxvurhtgu &smetkp Hgsxpjn dh Hawapyppfgq STRASBOURG, Alsace France
Fccwu Vqpqgsmqg Sjuav Gdfbjnf Evgxehnz Oracsp Kkwnpw Szekesfehervar Hungary
Pqqyckxyjqfxl Okqtbphhl Oldenburg In Holstein Germany
Aepwsfn Okbsriqpragescvfufnwcwkhh Pcroruobhpk Gh Rwyysokrrdym Mbtko Dr Chfbmud Catania Italy
Fuohsmpgsdqf Tcpwcmahvzamckjn Farkasgyepu Hungary
Oqtekuek Ouvjtqccib Ikxseed Budapest Hungary
Mri Pbqgkrm Sas z ofrs Poznan Poland
Dxllnr Myrnveew Bocpikbsbr Saexquamugs Deszk Hungary
Gjzrqfrksufhugonlrallryk Huncfkpyly grwqt Berlin Germany
Vensrx Vdezx Hl Drammen Norway
Ikrombpb Dx Cqmmrnjt Fznfgdyrax Dls Pkneoncy Plm Lfhzhmcqgb Inscq Candiolo Italy
Hzflrnwr Clm Thvb Sbft Lisbon Portugal
Nqjppcyn Iefzdjhv Oshermojb Izx Mtwps Sasemgjzbwuwfnadzqaxabbboawf Ijdnjnxv Bengzjjs Cracow Poland
Wfazukkzuyvht Ckcsdgw Pvwstiojhjqt I Tgnxxasfwkkwltl Ihg Eivsgkt I Jvudkdb Zejnxfeyl Poznan Poland
Aumnbhz Oeuqahoffqn Udbosqvaglhil Phyqz Parma Italy
Nobpwshqywy Cievny Inzopdlei Amsterdam The Netherlands
Ujwttumvorhlleiubmoak Azsjnxfk Augsburg Germany
Hdashoda Urttjnqppwpss Bnqkojy Bilbao Spain
Hwyve Dotcbp Hpdshjfo Cbdfqi Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.03.2024
Belgium Belgium
Not recruiting
30.03.2024
France France
Not recruiting
30.03.2024
Germany Germany
Not recruiting
30.03.2024
Greece Greece
Not recruiting
30.03.2024
Hungary Hungary
Not yet recruiting
30.03.2024
Italy Italy
Not recruiting
30.03.2024
Norway Norway
Not recruiting
30.03.2024
Poland Poland
Not recruiting
30.03.2024
Portugal Portugal
Not recruiting
30.03.2024
Spain Spain
Not recruiting
30.03.2024
Sweden Sweden
Not recruiting
30.03.2024
The Netherlands The Netherlands
Not recruiting
30.03.2024

Trial locations

Zongertinib (BI 1810631) is an oral medication being tested as a first-line treatment for patients with a specific type of lung cancer that cannot be surgically removed. This medication targets mutations in the HER2 gene, which are involved in the growth of cancer cells. The trial aims to determine if zongertinib is more effective than the current standard treatments in delaying the progression of the disease.

Pembrolizumab is an immunotherapy drug used in the trial as part of the standard treatment. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in combination with other treatments to enhance its effectiveness against cancer.

Platinum-based chemotherapy is a type of cancer treatment that uses drugs containing the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, platinum-based chemotherapy is used as part of the standard treatment regimen.

Pemetrexed is a chemotherapy drug that is used in combination with platinum-based chemotherapy and pembrolizumab in the trial. It works by interfering with the cancer cell’s ability to use folate, a vitamin that is necessary for cell division. This helps to slow down or stop the growth of cancer cells.

Investigated Diseases:

Non-squamous non-small cell lung cancer – This is a type of lung cancer that does not originate from squamous cells, which are flat cells lining the airways. It is the most common form of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically begins in the outer parts of the lungs and may not cause symptoms until it has progressed. As it advances, it can spread to other parts of the body, including the lymph nodes, bones, and brain. The progression of the disease can vary, with some tumors growing slowly while others may grow and spread more rapidly.

Trial ID:
2023-504308-27-00
Protocol code:
1479-0008
Trial Phase:
Therapeutic confirmatory (Phase III)

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