A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Launched by BAYER · Jun 5, 2024
Trial Information
Current as of October 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called BAY 2927088 for people with advanced non-small cell lung cancer (NSCLC) that has specific gene changes known as HER2 mutations. The goal is to find out if BAY 2927088 works better and is safer than the current standard treatments. In this study, participants will either take BAY 2927088 as a pill twice a day or receive standard treatment through an infusion (a method where medication is delivered directly into the bloodstream) every 21 days. The treatment will continue as long as it helps the participant without causing serious side effects.
To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with advanced NSCLC that is not suitable for standard curative treatments. They should also have a confirmed HER2 mutation. The study team will monitor participants closely, checking their health through various tests and scans to see how well the treatment is working and to identify any side effects. This trial is currently recruiting participants and aims to provide valuable information about a potential new treatment option for those facing this challenging disease.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
- • Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
- • Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
- • No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
- • Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
- Exclusion Criteria:
- * Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:
- • a. in situ cancers of cervix, breast, or skin,
- • b. superficial bladder cancer (Ta, Tis and T1),
- • c. limited-stage prostate cancer,
- • d. basal or squamous cancers of the skin.
- • Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
- • Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention.
- • Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).
- • History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
- • Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, Mazowieckie, Poland
Matosinhos, Portugal
Ovidiu, Romania
Timisoara, Romania
Madrid, Spain
Fribourg, Switzerland
Bilkent Ankara, Turkey
Dnipro, Ukraine
Kropyvnytskyi, Ukraine
Kyiv, Ukraine
Newport Beach, California, United States
Whittier, California, United States
Baltimore, Maryland, United States
Farmington Hills, Michigan, United States
Portland, Oregon, United States
Brasilia, Brazil
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Gießen, Hessen, Germany
Köln, Nordrhein Westfalen, Germany
Hemer, Germany
Stuttgart, Germany
Athens, Greece
Majadahonda, Madrid, Spain
Worcester, Massachusetts, United States
Buenos Aires, Argentina
Rivne, Ukraine
Uzhgorod, Ukraine
Torbay, Devon, United Kingdom
Blumenau, Brazil
Chaidari, Greece
Larissa, Greece
Chicago, Illinois, United States
Minneapolis, Minnesota, United States
Beijing, Beijing, China
Belfast, North Ireland, United Kingdom
Kyiv, Ukraine
Uzhgorod, Ukraine
Shanghai, Shanghai, China
Fortaleza, Brazil
Tainan, Taiwan
Orlando, Florida, United States
Adana, Turkey
Bilkent çankaya, Turkey
Chicago, Illinois, United States
Istanbul, Turkey
Caba, Ciudad Auton. De Buenos Aires, Argentina
Lisboa, Portugal
Lisboa, Portugal
Izmir, Turkey
Athens, Greece
Farmington Hills, Michigan, United States
Palermo, Italy
Varese, Italy
Viedma, Argentina
Porto Alegre Rs, Rio Grande Do Sul, Brazil
Hangzhou, Zhejiang, China
Chengdu, Sichuan, China
Olomouc, Czechia
Ostrava Vitkovice, Czechia
Taizhou, China
Zlin, Czechia
Stuttgart, Germany
Tatabanya, Hungary
Hong Kong, Hong Kong
Kowloon, Hong Kong
Bialystok, Poland
Shatin, Hong Kong
Flore¿Ti, Romania
Singapore, Singapore
Bucharest, Romania
Poprad, Slovakia
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Brno, Czechia
Trnava, Slovakia
Budapest, Hungary
Novy Jicin, Czechia
Essen, Germany
Sakarya, Turkey
Santa Monica, California, United States
Taichung, Taiwan
Nürnberg, Germany
Tainan, Taiwan
Whittier, Florida, United States
Wroclaw, Poland
Beijing, China
Changchun, Jilin, China
Hong Kong, Hong Kong
Bordeaux, France
Chengdu, China
Créteil, France
Matosinhos, Porto, Portugal
Villejuif Cedex, France
Coimbra, Portugal
Ube, Yamaguchi, Japan
Madrid, Spain
Perai, Malaysia
Cincinnati, Ohio, United States
Harbin, China
Dallas, Texas, United States
Nanjing, China
Xiamen, China
Recife, Pernambuco, Brazil
Aalborg, Denmark
Wuhan, Hubei, China
Copenhagen Oe, Denmark
Essen, North Rhine Westphalia, Germany
Giessen, Hessen, Germany
Piraeus, Greece
Nürnberg, Germany
Tainan, Taiwan
Taipei, Taiwan
Torquay, Devon, United Kingdom
Cardiff, United Kingdom
Nuevo León, Mexico
Edegem, Belgium
Rivne, Ukraine
New Hyde Park, New York, United States
Beijing, China
Pittsburgh, Pennsylvania, United States
Saint Herblain, France
Tampa, Florida, United States
Suresnes, France
Atlanta, Georgia, United States
Helsinki, Finland
Mexico, Distrito Federal, Mexico
Lodz, Poland
Nantes, France
Rivne, Ukraine
Nice, France
Herning, Denmark
Odense, Denmark
Turku, Finland
Barretos, Sao Paulo, Brazil
Meldola, Emilia Romagna, Italy
Chaidari, Greece
Orbassano, Piemonte, Italy
Aviano, Friuli Venezia Giulia, Italy
Verona, Italy
Padova, Veneto, Italy
Subang Jaya, Selangor, Malaysia
Taipei, Taiwan
Linyi, China
Taipei, Taiwan
Guangzhou, China
Zlin, Zlinsky Kraj, Czechia
Bauru, Brazil
Blumenau, Santa Catarina, Brazil
Atlanta, Georgia, United States
New Hyde Park, New York, United States
Valencia, Spain
Ostrava Vítkovice, Czechia
Portland, Oregon, United States
Richmond, Virginia, United States
Sofia, Bulgaria
Turku, Finland
Columbus, Georgia, United States
Farmington Hills, Michigan, United States
Athens, Greece
Athens, Greece
Majadahonda, Madrid, Spain
Petaling Jaya, Selangor, Malaysia
Barcelona, Spain
Shah Alam, Selangor, Malaysia
Madrid, Spain
Shanghai, China
Roma, Lazio, Italy
Helsinki, Finland
Avellino, Campania, Italy
Milano, Lombardia, Italy
Royal Oak, Michigan, United States
George Town,, Malaysia
Miramar, Florida, United States
Pamplona, Spain
Nanning, China
San Francisco, California, United States
Salzburg, Austria
Yuregir, Turkey
Salzburg, Austria
Brampton, Ontario, Canada
Suresnes, France
Villejuif Cedex, France
Beijing, Beijing, China
Harbin, Heilongjiang, China
Taizhou, Zhejiang, China
Jerusalem, Israel
Athens, Greece
Kitaadachi Gun, Saitama, Japan
Yonago, Tottori, Japan
Wien, Austria
Niigata, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Otwock, Poland
Poznan, Poland
Wien, Austria
Chaidari, Greece
Leuven, Vlaams Brabant, Belgium
Tel Aviv, Israel
Roeselare, West Flanders, Belgium
Montreal, Quebec, Canada
Wuhan, Hubei, China
Hangzhou, Zhejiang, China
Bologna, Emilia Romagna, Italy
Newport Beach, California, United States
Athens, Greece
Heidelberg, Australia
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, Brazil
Guangzhou, China
Fuzhou, Fujian, China
Hangzhou, China
Changsha, Hunan, China
Beijing, China
Wuhan, China
Harbin, China
København ø, Denmark
Forlì Cesena, Emilia Romagna, Italy
Hong Kong, Hong Kong
Avellino, Campania, Italy
Bologna, Emilia Romagna, Italy
Roma, Lazio, Italy
Milano, Lombardia, Italy
Matosinhos, Portugal
Subang Jaya, Malaysia
Milano, Lombardia, Italy
Padova, Veneto, Italy
Singapore, Singapore
Poprad, Slovakia
Kashiwa, Chiba, Japan
Barcelona, Spain
Sapporo, Hokkaido, Japan
Kaohsiung, Taiwan
Kiev, Ukraine
Pamplona, Spain
Essen, North Rhine Westphalia, Germany
Ostrava, Czechia
Hirakata, Osaka, Japan
Osakasayama, Osaka, Japan
Nuevo León, Mexico
Taipei, Taiwan
Panagyurishte, Pazardzhik, Bulgaria
Sofia, Bulgaria
Yüregir, Turkey
Kobe, Hyogo, Japan
Sagamihara, Kanagawa, Japan
Dnipropetrovsk, Ukraine
Flore?Ti, Comuna Floresti, Romania
Olomouc, Czechia
Köln, Nordrhein Westfalen, Germany
Antwerpen, Belgium
Ashdod, Israel
Cheras, Malaysia
Blumenau, Brazil
Bucuresti, Romania
Baden, Aargau, Switzerland
Buderim, Australia
Shah Alam, Malaysia
Wuhan, China
Xiamen, China
Istanbul, Turkey
Tainan, Taiwan
Garran, Australia
Antwerpen, Belgium
Leuven, Belgium
Linyi, China
Toronto, Ontario, Canada
Roeselare, Belgium
Montreal, Canada
Vancouver, Canada
Nanjing, Jiangsu, China
Porto Alegre, Rio Grande Do Sul, Brazil
Montpellier, France
Beijing, China
Mulhouse, France
Aalborg, Denmark
Herning, Denmark
Paris, France
København ø, Denmark
Odense, Denmark
Turku, Finland
Osakasayama Shi, Japan
Bordeaux, France
Sapporo, Japan
Ube, Japan
Cheongju Si, Chungcheongbugdo, Korea, Republic Of
Seoul, Korea, Republic Of
México, Distrito Federal, Mexico
Yangsan Si, Gyeongsangnamdo, Korea, Republic Of
Cdmx, Mexico
Naucalpan, Mexico
Gwangju, Korea, Republic Of
Jinju Si, Korea, Republic Of
San Pedro Garza García, Mexico
Nijmegen, Netherlands
Kielce, Poland
Lodz, Poland
Seoul, Korea, Republic Of
Matosinhos, Porto, Portugal
Kadikoy, Turkey
Barcelona, Spain
Barcelona, Spain
Madrid, Spain
Baden, Switzerland
Kucukcekmece, Turkey
Sakarya, Turkey
Yenimahalle, Turkey
Jinan, China
Shanghai, China
Torquay, United Kingdom
Aarhus N, Denmark
Valencia, Spain
Madrid, Spain
Valencia, Spain
Lund, Sweden
Umeå, Sweden
Kaohsiung City, Kaohsiung, Taiwan
Taichung, Taiwan
Liverpool, New South Wales, Australia
Recife, Brazil
Sao Paulo, Brazil
Sao Paulo, Brazil
Sao Paulo, Brazil
Barretos, Brazil
Panagyurishte, Bulgaria
Thessaloniki, Greece
Pleven, Bulgaria
Ashdod, Israel
Thessaloniki, Greece
Be'er Sheva, Israel
Pordenone, Friuli Venezia Giulia, Italy
Forlì Cesena, Italy
Roma, Lazio, Italy
Milano, Lombardia, Italy
Roma, Italy
Milano, Lombardia, Italy
Verona, Italy
Nagoya, Aichi, Japan
Himeji, Hyogo, Japan
Milano, Lombardia, Italy
Torino, Piemonte, Italy
Padova, Veneto, Italy
Avellino, Italy
Bologna, Italy
Sagamihara, Kanagawa, Japan
Sendai, Miyagi, Japan
A Coruna, Spain
Bunkyo Ku, Japan
Badalona, Spain
Barcelona, Spain
Fukuoka Shi, Japan
Hirakata, Japan
Pierre Bénite, France
Kashiwa, Japan
Brest, France
Kobe, Japan
Créteil, France
Osaka Shi, Japan
Lille, France
Comuna Floresti, Romania
Limoges, France
Paris, France
Nanjing, China
Nanning, China
Hollywood, Florida, United States
Singapore, Singapore
Singapore, Singapore
Houston, Texas, United States
La Tronche, France
Barañaín, Navarra, Spain
Lille, France
Newport Beach, California, United States
Limoges, France
Tampa, Florida, United States
Montpellier, France
Blacktown, New South Wales, Australia
Seoul, Korea, Republic Of
Puebla, Mexico
Mulhouse, France
Paris, France
Uzhhorod, Ukraine
Villejuif Cedex, France
Paris, France
Taipei, Taiwan
Pierre Bénite, France
Bunkyo Ku, Tokyo, Japan
Rouen, France
Frankfurt, Germany
Buenos Aires, Argentina
São José Do Rio Preto, Sao Paulo, Brazil
Concord, New South Wales, Australia
Córdoba, Argentina
Brampton, Ontario, Canada
Beijing, China
Brest, France
Roma, Lazio, Italy
Gießen, Hessen, Germany
Köln, Nordrhein Westfalen, Germany
Tbc, Argentina
Waratah, New South Wales, Australia
Jinju Si, Gyeongsangnam Do, Korea, Republic Of
Hwasun Gun, Korea, Republic Of
København ø, Denmark
Petaling Jaya, Selangor, Malaysia
Kuala Lumpur, Malaysia
Odense C, Denmark
San Diego, California, United States
Copenhagen, Denmark
Hong Kong, Hong Kong
Kiev, Ukraine
Padova, Veneto, Italy
Kirovograd, Ukraine
Kyiv, Ukraine
Lutsk, Ukraine
Varna, Bulgaria
Bucuresti, Romania
Singapore, Singapore
Craiova, Romania
Craiova, Romania
Natal, Rio Grande Do Norte, Brazil
Vancouver, Canada
La Tronche, France
Singapore, Singapore
Osaka, Japan
Amsterdam, Netherlands
Beijing, China
Paris Cedex 5, France
Bordeaux Cedex, France
Rozzano, Lombardia, Italy
Rouen, France
Cluj Napoca, Romania
Saint Herblain, France
Porto, Portugal
Cluj Napoca, Romania
Sofia, Bulgaria
Tainan, Tnn, Taiwan
Budapest, Hungary
Belfast, North Ireland, United Kingdom
Guildford, Surrey, United Kingdom
Fukuoka, Japan
San Diego, California, United States
Vancouver, British Columbia, Canada
San Francisco, California, United States
Santa Monica, California, United States
Beijing, Beijing, China
Seoul, Korea, Republic Of
Changsha, Hunan, China
Hangzhou, Zhejiang, China
Shanghai, China
Coimbra, Portugal
Madrid, Spain
Montpellier, France
Villejuif, France
Nanjing, China
Nový Jicín, Czechia
Berlin, Germany
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Fort Lauderdale, Florida, United States
Firenze, Italy
Chicago, Illinois, United States
Chicago, Illinois, United States
Lecce, Italy
Baltimore, Maryland, United States
Milano, Italy
Worcester, Massachusetts, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Houston, Texas, United States
Plovdiv, Bulgaria
Plovdiv, Bulgaria
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported