New pill targets tough lung cancers in first human trial

NCT ID NCT05099172

Recruiting now Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This study tests a new oral drug, BAY 2927088, for people with advanced non-small cell lung cancer that has specific EGFR or HER2 mutations. The trial has four parts to find the safest dose and see if the drug shrinks tumors. About 400 participants will take the drug daily until their cancer worsens or side effects become too severe.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: BAY 2927088 (sevabertinib)
What this could lead to: If successful, this could lead to a new targeted oral treatment for people with advanced lung cancer that has specific EGFR or HER2 mutations.
What could go wrong: This is an early first-in-human study, so safety and effectiveness are not yet known. The drug may not work or could cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED NON-SMALL CELL LUNG CANCER EGFR MUTATION HER2 MUTATION

Contacts and locations

Locations

AP-HM - Hopital de la Timone - Centre d'Essais en Cancerologie
WITHDRAWN

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France
AZ Delta | Clinical Trial Center - Pneumology
ACTIVE_NOT_RECRUITING

Roeselare, West Flanders, 8800, Belgium
Aichi Cancer Center Hospital
ACTIVE_NOT_RECRUITING

Nagoya, Aichi-ken, 464-8681, Japan
Asan Medical Center | Oncology
ACTIVE_NOT_RECRUITING

Seoul, 05505, South Korea
Azienda Ospedaliero Universitaria Parma - SC Oncologia Medica
ACTIVE_NOT_RECRUITING

Parma, 43126, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
ACTIVE_NOT_RECRUITING

Orbassano, 10043, Italy
Banner MD Anderson Cancer Center at Banner Gateway Medical Center
COMPLETED

Gilbert, Arizona, 85234, United States
Beijing Cancer Hospital - Oncology Department
ACTIVE_NOT_RECRUITING

Beijing, Beijing Municipality, 100142, China
Beijing Hospital
ACTIVE_NOT_RECRUITING

Beijing, Beijing Municipality, 100730, China
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
COMPLETED

Detroit, Michigan, 48202, United States
Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia
COMPLETED

Verona, 37134, Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati
ACTIVE_NOT_RECRUITING

Aviano, 33081, Italy
Chaim Sheba Medical Center
COMPLETED

Ramat Gan, 5262000, Israel
Chang Gung Memorial Hospital at Linkou
ACTIVE_NOT_RECRUITING

Taoyuan, 33305, Taiwan
Chi-Mei Medical Center, Liouyine
ACTIVE_NOT_RECRUITING

Tainan, 73657, Taiwan
Chung Shan Medical University Hospital
WITHDRAWN

Taichung, 402306, Taiwan
Chungbuk National University Hospital | Hematology and Oncology
ACTIVE_NOT_RECRUITING

Chungcheongbuk-do, North Chungcheong, 28644, South Korea
City of Hope - Duarte Cancer Center
COMPLETED

Duarte, California, 91010, United States
Curie Oncology | Mount Elizabeth Novena
ACTIVE_NOT_RECRUITING

Singapore, 329563, Singapore
Dana-Farber Cancer Institute - Oncology Department
COMPLETED

Boston, Massachusetts, 02215, United States
Emory Winship Cancer Institute
ACTIVE_NOT_RECRUITING

Atlanta, Georgia, 30322, United States
Erasmus University Medical Center | Research Department - Lung Diseases
COMPLETED

Rotterdam, South Holland, 3015 GD, Netherlands
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
ACTIVE_NOT_RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
ACTIVE_NOT_RECRUITING

Roma, 00128, Italy
Fujian Cancer Hospital
ACTIVE_NOT_RECRUITING

Fuzhou, Fujian, 350014, China
Gustave Roussy - Departement Oncologie-Radiotherapie
COMPLETED

Villejuif, Île-de-France Region, 94805, France
Harbin Medical University Cancer Hospital
TERMINATED

Harbin, Heilongjiang, 150000, China
Hokkaido University Hospital
ACTIVE_NOT_RECRUITING

Sapporo, Hokkaido, 060-8648, Japan
Hong Kong United Oncology Centre
RECRUITING

Kowloon, 00000, Hong Kong
Hopital Nord Laennec - Oncologie medicale thoracique et digestive
ACTIVE_NOT_RECRUITING

Nantes, Pays de la Loire Region, 44093, France
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
WITHDRAWN

São Paulo, 05651-901, Brazil
Hospital Universitari Dexeus Grupo Quironsalud | Oncologia
ACTIVE_NOT_RECRUITING

Barcelona, 08028, Spain
Hospital Universitari Vall D Hebron | Oncologia
ACTIVE_NOT_RECRUITING

Barcelona, 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz | Oncologia
ACTIVE_NOT_RECRUITING

Madrid, 28040, Spain
Hospital Universitario Hm Sanchinarro | Oncologia
COMPLETED

Madrid, 28050, Spain
Hospital Universitario Virgen De La Victoria | Oncologia
WITHDRAWN

Málaga, 29010, Spain
Hospital Universitario Y Politecnico La Fe | Oncologia
ACTIVE_NOT_RECRUITING

Valencia, 46026, Spain
Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
WITHDRAWN

São José do Rio Preto, São Paulo, 15090-000, Brazil
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
ACTIVE_NOT_RECRUITING

Rozzano, 20089, Italy
Hunan Cancer Hospital - Oncology Department
ACTIVE_NOT_RECRUITING

Changsha, Hunan, 410013, China
IPO Porto
RECRUITING

Porto, 4200-072, Portugal
Inova Schar Cancer Insitute - Inova Fairfax Hospital
WITHDRAWN

Fairfax, Washington, 22031, United States
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
COMPLETED

Bordeaux, New Aquitaine, 33000, France
Institut Catala D'oncologia | Hospitalet | Oncologia
ACTIVE_NOT_RECRUITING

L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Institut Curie - Paris - Oncologie medicale
COMPLETED

Paris, Île-de-France Region, 75248, France
Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale
ACTIVE_NOT_RECRUITING

Saint-Herblain, Pays de la Loire Region, 44800, France
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative
COMPLETED

Milan, 20141, Italy
Kanagawa Cancer Center
ACTIVE_NOT_RECRUITING

Yokohama, Kanagawa, 241-8515, Japan
Kindai University Hospital
ACTIVE_NOT_RECRUITING

Sakai, Osaka, 590-0197, Japan
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
ACTIVE_NOT_RECRUITING

Natal, Rio Grande do Norte, 59040-000, Brazil
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
ACTIVE_NOT_RECRUITING

Nanjing, Jiangsu, 210008, China
National Cancer Center Hospital
ACTIVE_NOT_RECRUITING

Chuo-ku, Tokyo, 104-0045, Japan
National Cancer Center Hospital East
ACTIVE_NOT_RECRUITING

Kashiwa, Chiba, 277-8577, Japan
National Cancer Center Singapore - Oncology Department
ACTIVE_NOT_RECRUITING

Singapore, 168583, Singapore
National Cheng Kung University Hospital
ACTIVE_NOT_RECRUITING

Tainan, 704, Taiwan
National Hospital Organization Shikoku Cancer Center
COMPLETED

Matsuyama, Ehime, 791-0280, Japan
National Taiwan University Hospital
ACTIVE_NOT_RECRUITING

Taipei, 100, Taiwan
National University Hospital Medical Centre
ACTIVE_NOT_RECRUITING

Singapore, 119074, Singapore
Nederlands Kanker Instituut
ACTIVE_NOT_RECRUITING

Amsterdam, North Holland, 1066 CX, Netherlands
Okayama University Hospital
TERMINATED

Okayama, 700-8558, Japan
Osaka International Cancer Institute
ACTIVE_NOT_RECRUITING

Osaka, 541-8567, Japan
Prince of Wales Hospital
ACTIVE_NOT_RECRUITING

Hong Kong, Hong Kong SAR, 00000, Hong Kong
Qilu Hosp., Shandong Univ.
TERMINATED

Jinan, Shandong, 250012, China
Queen Mary Hospital
ACTIVE_NOT_RECRUITING

Hong Kong, Hong Kong SAR, 00000, Hong Kong
Rabin Medical Center | Beilinson Campus
COMPLETED

Petah Tikva, 4941492, Israel
Radboud University Medical Center | Afdeling Interne Geneeskunde
WITHDRAWN

Nijmegen, Gelderland, 6500 HB, Netherlands
Roswell Park Comprehensive Cancer Center
WITHDRAWN

Buffalo, New York, 14263, United States
START Research Portugal
WITHDRAWN

Lisbon, 1649-028, Portugal
Samsung Medical Center | Oncology
ACTIVE_NOT_RECRUITING

Seoul, 06351, South Korea
Seoul National University Bundang Hospital | Hematology and Medical Oncology
COMPLETED

Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital | Oncology
ACTIVE_NOT_RECRUITING

Jongno -Gu, Seoul, 03080, South Korea
Severance Hospital | Oncology
ACTIVE_NOT_RECRUITING

Seoul, 03722, South Korea
Shandong University - Shandong Cancer Hospital
ACTIVE_NOT_RECRUITING

Jinan, Shandong, 250117, China
Shanghai Chest Hospital, Shanghai Jiaotong University
ACTIVE_NOT_RECRUITING

Shanghai, Shanghai Municipality, 200030, China
Shizuoka Cancer Center
COMPLETED

Sunto, Shizuoka, 411-8777, Japan
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
ACTIVE_NOT_RECRUITING

Hangzhou, Zhejiang, 310016, China
St Vincent's Hospital | Oncology
ACTIVE_NOT_RECRUITING

Suwon, Gyeonggi-do, 16247, South Korea
Taichung Veterans General Hospital
ACTIVE_NOT_RECRUITING

Taichung, 40705, Taiwan
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)
WITHDRAWN

Taipei, 23561, Taiwan
Tennessee Oncology - Nashville Centennial Clinic
RECRUITING

Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
WITHDRAWN

Bethesda, Maryland, 20817, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
ACTIVE_NOT_RECRUITING

Houston, Texas, 77030, United States
Tottori University Hospital
COMPLETED

Yonago, Tottori, 683-8504, Japan
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
ACTIVE_NOT_RECRUITING

Lyon, Auvergne-Rhône-Alpes, 69373, France
UZ Leuven Gasthuisberg - Pneumology Department
ACTIVE_NOT_RECRUITING

Leuven, Flemish Brabant, 3000, Belgium
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech
ACTIVE_NOT_RECRUITING

Wuhan, Hubei, 430023, China
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Łodzi
WITHDRAWN

Lodz, 92-213, Poland
Uniwersyteckie Centrum Kliniczne
WITHDRAWN

Gdansk, 80-214, Poland
Virginia Cancer Specialists, PC - Fairfax
COMPLETED

Fairfax, Washington, 22031, United States
West China Hospital Sichuan University
ACTIVE_NOT_RECRUITING

Chengdu, Sichuan, 610041, China
Zhejiang Cancer Hospital
ACTIVE_NOT_RECRUITING

Hangzhou, Zhejiang, 310022, China
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province
ACTIVE_NOT_RECRUITING

Taizhou, Jiangsu, 317000, China

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