Study on the Effectiveness and Safety of BAY 2927088 Compared to Standard Treatment in 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 advanced non-small cell lung cancer (NSCLC) that has specific changes in the genes called HER2 mutations. The study is testing a new treatment called BAY 2927088, which is taken as a tablet, to see how well it works and how safe it is compared to the usual treatments. The usual treatments include a combination of medicines such as pembrolizumab, pemetrexed, cisplatin, and carboplatin, which are given through an infusion into a vein.

The purpose of the study is to find out if BAY 2927088 can help patients live longer without their cancer getting worse. Participants in the study will be randomly assigned to receive either the new treatment or the standard treatment. The study will monitor the participants over a period of time to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, participants will have regular check-ups and tests to track their health and the progress of their cancer. The study aims to provide valuable information on whether BAY 2927088 could be a better option for treating this type of lung cancer in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of advanced non-small cell lung cancer with a specific mutation in the HER2 gene.

Eligibility criteria include being 18 years or older and having no prior systemic therapy for advanced disease.

2 treatment assignment

Participants are randomly assigned to receive either the experimental treatment or the standard treatment.

The experimental treatment involves taking BAY 2927088 orally in the form of coated tablets.

3 standard treatment

The standard treatment consists of a combination of medications administered through intravenous (IV) infusion.

These medications include pembrolizumab, pemetrexed, and either cisplatin or carboplatin.

4 treatment duration

The treatment continues for a specified duration, with regular monitoring to assess the response to the therapy.

The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the cancer does not worsen.

5 monitoring and assessments

Throughout the trial, regular assessments are conducted to monitor the effectiveness and safety of the treatment.

These assessments include imaging tests and evaluations of symptoms and overall health.

6 completion of trial

The trial is expected to conclude by May 2028, with final assessments to determine the overall outcomes of the treatments.

Participants will be informed of the results and any further steps if necessary.

Who Can Join the Study?

  • Participant must be at least 18 years old or older, depending on the legal age of consent in their country, at the time of signing the informed consent.
  • Must have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or has spread to other parts of the body. This should be confirmed through specific medical tests. Small cell lung cancer or mixed types are not included.
  • Must have a specific change, called an activating HER2 mutation, in a part of the cancer cell known as the tyrosine kinase domain. This should be confirmed by a tissue test done in a certified laboratory.
  • Must not have received any previous treatment for advanced or spreading disease. Also, must not have been treated with medicines targeting the HER2 mutation. If they had treatment after surgery or before surgery, it should have been completed at least 12 months before the start of the study.
  • Must be eligible to receive a specific type of chemotherapy treatment, which includes medicines like cisplatin/pemetrexed or carboplatin/pemetrexed, along with pembrolizumab, according to the product information.

Who Cannot Join the Study?

  • Patients with a different type of lung cancer that is not advanced non-small cell lung cancer with a HER2 (ERBB2) mutation cannot participate. The HER2 (ERBB2) mutation is a specific change in the genes that can affect cancer growth.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not part of the specified clinical trial groups cannot participate. Clinical trial groups are categories that help organize participants based on certain characteristics.
  • Patients who are not male or female cannot participate, as the study includes both male and female subjects.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups that 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 Status
Klinikum Nuernberg Nürnberg Germany
Centre Antoine Lacassagne Nice France
General University Hospital Of Larissa Larissa Greece
IRCCS Humanitas Research Hospital Rozzano Italy
Laiko General Hospital Of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
Hospital Universitario da A Coruna A Coruna Galicia Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Odense University Hospital Odense Denmark
Centre Hospitalier Intercommunal Creteil Creteil France
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Medical University Of Vienna Vienna Austria
Region Skane Skanes Universitetssjukhus Lund Sweden
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Montpellier Montpellier France
Kliniken der Stadt Koeln gGmbH Cologne Germany
Aalborg University Hospital Aalborg Denmark
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Lille Lille France
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Centre Hospitalier Regional Et Universitaire De Brest Brest France
University Of Antwerp Edegem Belgium
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitaetsklinikum Essen AöR Essen Germany
Institut Gustave Roussy Villejuif France
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Uniklinikum Salzburg Salzburg Austria
Istituto Oncologico Veneto Padua Italy
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Palermo Italy
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Centre Hospitalier Et Universitaire De Limoges Limoges France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Champalimaud Clinical Centre Lisbon Portugal
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Goethe University Frankfurt Frankfurt Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Hospital Foch Suresnes France
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Region Vaesterbotten Umea Sweden
National Institute Of Tuberculosis And Lung Diseases Warsaw Poland
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Region Jaemtland Haerjedalen Ostersund Sweden
Region Norrbotten Lulea Sweden
Region Vaesternorrland Sundsvall Sweden
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
AORN San Giuseppe Moscati Avellino Avellino Italy
Krajska Nemocnice T Bati a.s. Zlin Czechia
Henry Dunant Hospital Center Athens Greece
Comite Entreprise Paul Papin Angers France
Centro Hospitalar E Universitario De Coimbra E.P.E. Coimbra Portugal
Institut Curie – Site Paris Paris France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece

Other Sites

Site Name City Country Status
Cardiomed S.R.L. Cluj Napoca Romania
University Hospital St Marina Varna Varna Bulgaria
Bnyuphjjk Uckngt Ueobq Klfcor Budapest Hungary
Fcmhzgxo Nhbkkndlp Tawnlr Trnava Slovakia
Ojnykjho Vcxl Fsnbn Lfmlq Lecce Italy
Dxhxxkmf Oq Helsinki Finland
Mcix Spjthvg Lzhm Sofia Bulgaria
Pqmh Prrdhj smxukx Poprad Slovakia
Gsispgx Mzynd Ioeygclx Kyfemqi Gyqmnrpc Acwy Mlqnbrjpn Gltycmwbwlykk Cuzluioddhjy Thessaloniki Greece
Uehnxbvmqu Shwrgebwqdp Hbkclggu Fjk Asopvm Twunnjimy Ig Opngnqsr Edt Sofia Bulgaria
Obzaiucmiw Owlaobpji Cbxaqtl Sgfxfh Timisoara Romania
Wbejsvqkzhdga Cotxikh Pzfpqdlijrfb I Tgkfinzvkyecrbo Irl Evladzf I Jgmvdtg Zlojvulqx Poznan Poland
Rsamve Bplqk Kpuaxblbihm Gykb Stuttgart Germany
Nbjqanpyd Anxw Ogtutudbnhxpyxssv axhu Ostrava Czechia
Oaiytgv Sfyaid Craiova Romania
Rxqwfuoexvtu Clblul Cyfr Subdel Floresti Romania
Ubmfqah Lcfie Di Szbfd Dc Mhavnbgsfp Eiwabd Senhora Da Hora Portugal
Olsypgp Cqnjfyyh Hgfuvyyk Sdvkwv Ovidiu Romania
Mbpamuipnhew Hcoihvch Fgy Actyvp Tiejahqwcgfmy Hkxgellp Lmiw Panagyurishte Bulgaria
Msozavonosaxi Htwsdwea fqp Axjljp Typeqbzlt Hdjui aab Bwrkk Euz Pleven Bulgaria

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
28.10.2024
Belgium Belgium
Not recruiting
28.10.2024
Bulgaria Bulgaria
Not recruiting
28.10.2024
Czechia Czechia
Not recruiting
28.10.2024
Denmark Denmark
Not recruiting
28.10.2024
Finland Finland
Not recruiting
28.10.2024
France France
Not recruiting
28.10.2024
Germany Germany
Not recruiting
28.10.2024
Greece Greece
Not recruiting
28.10.2024
Hungary Hungary
Not recruiting
28.10.2024
Italy Italy
Not recruiting
28.10.2024
Poland Poland
Not recruiting
28.10.2024
Portugal Portugal
Not recruiting
28.10.2024
Romania Romania
Not recruiting
28.10.2024
Slovakia Slovakia
Not recruiting
28.10.2024
Spain Spain
Not recruiting
28.10.2024
Sweden Sweden
Not recruiting
28.10.2024
The Netherlands The Netherlands
Not recruiting
28.10.2024

Trial locations

BAY 2927088 is an experimental medication being tested for its effectiveness and safety in treating patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain genetic changes called HER2-activating mutations. This medication is taken by mouth and is being compared to the usual treatments to see if it can help patients live longer without their cancer getting worse.

Advanced Non-Small Cell Lung Cancer with HER2 (ERBB2) Mutation – This is a type of lung cancer characterized by the presence of a specific genetic mutation in the HER2 gene, also known as ERBB2. It is a subtype of non-small cell lung cancer, which is the most common form of lung cancer. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. The HER2 mutation can lead to uncontrolled cell growth, contributing to the progression of the cancer. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower progression.

Trial ID:
2024-511319-91-00
Protocol code:
22615
Trial Phase:
Therapeutic confirmatory (Phase III)

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