First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC. The main purpose of this study is to learn: Escalation, Backfill, and Expansion Part: * How safe is BAY2927088 for the participants? * What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants? * How does BAY2927088 move into, through, and out of the bodies of the participants? For this, the researchers will measure the followings: * The number of participants with medical problems, also called adverse events and serious adverse events, and their severity * The number of participants who discontinue study treatment due to an adverse event. * The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088 * Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level * The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088 * The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part * How well does BAY2927088 work in participants? For this, the researchers will measure the following: • Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor. This study has 4 parts: * The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive. * The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part. * The expansion part aims to determine the dose of BAY2927088 to be tested in further studies. * The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well. The participants in this study will take the study treatment BAY2927088 in 3-week periods called "cycles". They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle. During the study, the study team will: * take blood and urine samples, * check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans, * check the participants' overall health and heart health, * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is considered "serious" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent ma zaawansowanego raka płuc (NSCLC), który nie nadaje się do leczenia standardowego lub powrócił/rozprzestrzenił się.
- •Rak płuc posiada potwierdzone "uszkodzenia" (mutacje) w genach EGFR lub HER2.
- •Pacjent wcześniej leczył się na zaawansowanego raka płuc.
- •Dostępna jest próbka guza (świeża lub z archiwum), aby sprawdzić zmiany w genach.
- •Rak płuc daje się zmierzyć na obrazach RTG/rezonansie i widoczne są objawy choroby.
- •Ogólny stan zdrowia pacjenta jest dobry (wg skali ECOG 0 lub 1).
- •Oczekiwana długość życia pacjenta to co najmniej 12 tygodni.
✗ Disqualifies
- •Rak płuc jest innego typu niż niedrobnokomórkowy lub zawiera więcej niż jeden typ komórek.
- •Pacjent nie miał wcześniej żadnego leczenia systemowego zaawansowanego raka płuc (dotyczy grup F i H).
- •Pacjent brał udział w innych badaniach klinicznych niedawno.
- •Pacjent ma inne poważne choroby, które mogą wpływać na bezpieczeństwo badania.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (94)
Banner MD Anderson Cancer Center at Banner Gateway Medical Center
Gilbert, United States
City of Hope - Duarte Cancer Center
Duarte, United States
Emory Winship Cancer Institute
Atlanta, United States
The Center for Cancer and Blood Disorders
Bethesda, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, United States
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
Detroit, United States
Roswell Park Comprehensive Cancer Center
Buffalo, United States
NYU Langone Hospital - Long Island - Urology
Mineola, United States
Tennessee Oncology - Nashville Centennial Clinic
Nashville, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, United States
Virginia Cancer Specialists, PC - Fairfax
Fairfax, United States
UZ Leuven Gasthuisberg - Pneumology Department
Leuven, Belgium
AZ Delta | Clinical Trial Center - Pneumology
Roeselare, Belgium
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
Natal, Brazil
Hospital de Base | Integrated Research Center
São José do Rio Preto, Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
São Paulo, Brazil
Beijing Cancer Hospital - Oncology Department
Beijing, China
Beijing Hospital
Beijing, China
Fujian Cancer Hospital
Fuzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
Wuhan, China
Hunan Cancer Hospital - Oncology Department
Changsha, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, China
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
Taizhou, China
Qilu Hosp., Shandong Univ.
Jinan, China
Shandong University - Shandong Cancer Hospital
Jinan, China
Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai, China
West China Hospital Sichuan University
Chengdu, China
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
Lyon, France
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, France
Hopital Nord Laennec - Oncologie medicale thoracique et digestive
Nantes, France
Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale
Saint-Herblain, France
AP-HM - Hopital de la Timone - Centre d'Essais en Cancerologie
Marseille, France
Institut Curie - Paris - Oncologie medicale
Paris, France
Gustave Roussy - Departement Oncologie-Radiotherapie
Villejuif, France
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Hong Kong United Oncology Centre
Kowloon, Hong Kong
Rabin Medical Center | Beilinson Hospital - Nephrology and Hypertension Institute
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Istituto Nazionale Tumori IRCCS Fondazione G.Pascale
Naples, Italy
Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica
Parma, Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
Aviano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
Rome, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
Milan, Italy
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
Milan, Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
Orbassano, Italy
Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
Verona, Italy
Aichi Cancer Center Hospital
Nagoya, Japan
National Cancer Center Hospital East
Kashiwa, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Hokkaido University Hospital
Sapporo, Japan
Kanagawa Cancer Center
Yokohama, Japan
Kindai University Hospital
Sakai, Japan
Shizuoka Cancer Center
Sunto, Japan
National Cancer Center Hospital
Chuo-ku, Japan
Tottori University Hospital
Yonago, Japan
Okayama University Hospital
Okayama, Japan
Osaka International Cancer Institute
Osaka, Japan
Radboud University Medical Center | Afdeling Interne Geneeskunde
Nijmegen, Netherlands
Nederlands Kanker Instituut
Amsterdam, Netherlands
Erasmus University Medical Center | Research Department - Lung Diseases
Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi
Lodz, Poland
START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa Norte
Lisbon, Portugal
Hospital Santa Maria | Centro de Investigacao Clinica
Lisbon, Portugal
IPO Porto
Porto, Portugal
National University Hospital Medical Centre
Singapore, Singapore
National Cancer Center Singapore - Oncology Department
Singapore, Singapore
Curie Oncology | Mount Elizabeth Novena
Singapore, Singapore
Seoul National University Bundang Hospital
Seongnam-si, South Korea
St.Vincent's Hospital
Suwon, South Korea
Chungbuk National University Hospital | Hematology and Oncology
Chungcheongbuk-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System - Oncology Department
Seoul, South Korea
Asan Medical Center | Oncology
Seoul, South Korea
Samsung Medical Center - Oncology Department
Seoul, South Korea
Institut Catala D'oncologia | Hospitalet | Oncologia
L'Hospitalet de Llobregat, Spain
Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
Barcelona, Spain
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia
Madrid, Spain
Hospital Universitario Hm Sanchinarro | Oncologia
Madrid, Spain
Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, Spain
Hospital Universitario Y Politecnico La Fe | Oncologia
Valencia, Spain
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chi-Mei Medical Center, Liouyine
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
Taipei, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan, Taiwan
Trial contact
Bayer Clinical Trials Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.