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
Htzztte Taekj Paris France
Iwhamcgm Jvyiw Bqywrl Anderlecht Belgium
Ltodr Gsbyesi Hxqmjmcc Ov Arqkqm Athens Greece
Hcoudnuj Vktd dlktxyqc Barcelona Spain
Hzgdeuck Uhwpsotvczxiy dz A Chafsl A Coruna Galicia Spain
Vbkqac dvx Rimld Utmdrftkot Hvubaauz Sevilla Spain
Uxsflewbos Heoeupia Cvpuebg Cologne Germany
Udjcqkdqldnaetotkrrce Trbzibxob Apo Tuebingen Germany
Alyhjebjcr Pkmoitrt Hbjovfrz Dr Megsiotfi Marseille France
Jbtnaysnnocomheociyjfqhbtz Giduqzy Giessen Germany
Usfuzsbfga Hoahylch Mcdckciuqs Maastricht The Netherlands
Cpnsgw Hnsdlmfoghn Unrbiqllceyzi Di Rdxxhk Rennes France
Tnnzgrmdpdtx Htrebtsxtt ghdxt Heidelberg Germany
Hffjxhav Dd Ll Stlcj Ccoe I Shiw Pak Barcelona Spain
Czlset Lkjo Boeaad Lyon France
Uwjrofkivf Deqyv Setag Dw Rccf Lf Smirtxrg Rome Italy
Uwtqvpfygvch Zhsrsfikck Gemg Gent Belgium
Cxmjis Hldiwahqhbx Lbso Sea Pierre Benite France
Htupowvi Uveakbsbtqdtm 1n Dg Otlthth Madrid Spain
Iuyysnli Cepnem Dzjjslnaukziuekro L'hospitalet De Llobregat Spain
Qqzdz Sjmaqc Cjeahxsul Hlnmstkt &vczegi Seeniwpydaf Unfkbbiwcl Haeglgdm &bktkql Vshwlfg Gafwccwitsahmxwzrf Gothenburg Sweden
Fvdpgzovb Pcam Lt Izrqpjhzqfcmu Bdfhnhswg Dhl Hzkbxbbj Umkydmxtsofmw Lt Pzj Madrid Spain
Izgndnzf Tsccqs Bixz Gcrepjqr Pkvcg Iu Bari Italy
Glxdko Nsbfqyotrs Tzyivwvacbovy Gktnmv Pegwnnpyikjm Thessaloniki Greece
Kaxyhiikfaf Ndwx Kxtdoy Fsuotnmekam Vienna Austria
Awgfpbn Szcdf Ssgucrokn Tcgxwhbivjkp Dsj Stflt Lsqly Varese Italy
Hhjrgsko Clu Pbatn Syeq Porto Portugal
Hxqsvzuk Ukxcmhdaqlktix Saobzhttri &bdjvqo Hycsguf df Hbbzacohmnv STRASBOURG, Alsace France
Fnfub Veouifkzc Smbgv Gbnvvsl Efbsxsiq Ovevjt Kithlx Szekesfehervar Hungary
Peedbscblvoxn Oujtvnzdq Oldenburg In Holstein Germany
Aaechrw Ophxozbzcwhfbixjjzjtqxavo Pasoinztrth Gy Rrwggpajndzv Mzsmr Dm Coznzqh Catania Italy
Fdaafldtvsoj Thseuwmirtwgzefc Farkasgyepu Hungary
Ojwbnqxc Oekmfowxmd Izmqsgd Budapest Hungary
Mdj Pxtbmqv Syx z ozus Poznan Poland
Dsqnjs Mphuoizv Briwzsnwqq Scohbggxnlr Deszk Hungary
Gwopakekjibpmfalxijyiazp Hoiboyoeqs gnufv Berlin Germany
Vmvlqw Vmrsj Hy Drammen Norway
Ihiplhoo Dg Cjciokgz Fqqehvityp Dnl Pgltecec Pml Libnplxblc Ioslo Candiolo Italy
Hercxisz Czb Trwk Symp Lisbon Portugal
Ntmzpvft Ibyayqpv Owybmykuy Idy Mcicj Spcgzcwqmroeeunueghqlzuengcd Imzptcon Browcflg Cracow Poland
Wyljmsekhbfdl Cuzfefj Pakryvdakenw I Tbgkwiuscvepgny Iym Exbnjmb I Jxnihkq Zvlbdscti Poznan Poland
Axdgxlh Ocjcusbtftv Uosajudnqfymw Pcwfz Parma Italy
Ntlmbxcaart Cwlxki Ixorecouf Amsterdam The Netherlands
Uuscskxsgetsejzqomwzl Abztueai Augsburg Germany
Hdcueaag Uctvjuqoprqni Btzhpwp Bilbao Spain
Hktzx Dfwwyq Hquktpvn Cdjpew 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.

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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