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New pill targets tough lung cancers in first human trial

NCT ID NCT05099172

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded). * Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible. Note: Except for participants eligible for Group F and Group H (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease. * Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant. * Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable. * Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \[US\] sites) or an equally accredited (outside of the US) local laboratory. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Minimum life expectancy of 12 weeks. * Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment: 1. Hemoglobin ≥ 9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing. 2. Platelets ≥ 100 × 10\^9 cells/L. 3. Absolute neutrophil count ≥ 1.5 ×10\^9 cells/L. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing. * Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment: a. Estimated glomerular filtration rate (eGFR) \> 50 mL/min per 1.73 m\^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula. * Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment: 1. Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis). 2. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor). Exclusion Criteria: * Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug. * Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug. * Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug. * Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug. * Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor. * Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery). * History of spinal cord compression or brain metastases with the following exceptions: 1. Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill. 2. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion/Extension (with the exception of Group G and Group H) if all of the following criteria are met: * there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. * Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib. 3. Participants with history of spinal cord compression \>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic. 4. Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg/day dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible. * History of congestive heart failure (CHF) Class \>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec). * Participants with: 1. Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator's discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells/uL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies/mL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months 2. Active Hepatitis B infection (positive for Hepatitis B surface antigen \[HbsAg\]) and Hepatitis B virus \[HBV\] DNA). 3. Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay). NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment. * Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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