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 November 12, 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
Belfast, North Ireland, United Kingdom
Chicago, Illinois, United States
Minneapolis, Minnesota, United States
Beijing, Beijing, China
Shanghai, Shanghai, China
Kyiv, Ukraine
Uzhgorod, Ukraine
Tainan, Taiwan
Adana, Turkey
Bilkent çankaya, Turkey
Fortaleza, Brazil
Orlando, Florida, United States
Caba, Ciudad Auton. De Buenos Aires, Argentina
Chicago, Illinois, United States
Istanbul, Turkey
Lisboa, Portugal
Izmir, Turkey
Lisboa, Portugal
Athens, Greece
Palermo, Italy
Varese, Italy
Farmington Hills, Michigan, United States
Viedma, Argentina
Porto Alegre Rs, Rio Grande Do Sul, Brazil
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Taizhou, China
Olomouc, Czechia
Ostrava Vitkovice, Czechia
Zlin, Czechia
Stuttgart, Germany
Hong Kong, Hong Kong
Kowloon, Hong Kong
Shatin, Hong Kong
Tatabanya, Hungary
Bialystok, Poland
Bucharest, Romania
Flore¿Ti, Romania
Singapore, Singapore
Poprad, Slovakia
Trnava, Slovakia
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Brno, Czechia
Novy Jicin, Czechia
Essen, Germany
Nürnberg, Germany
Budapest, Hungary
Sakarya, Turkey
Santa Monica, California, United States
Taichung, Taiwan
Tainan, Taiwan
Wroclaw, Poland
Whittier, Florida, United States
Changchun, Jilin, China
Beijing, China
Chengdu, China
Hong Kong, Hong Kong
Bordeaux, France
Créteil, France
Villejuif Cedex, France
Ube, Yamaguchi, Japan
Matosinhos, Porto, Portugal
Coimbra, Portugal
Madrid, Spain
Cincinnati, Ohio, United States
Perai, Malaysia
Harbin, China
Nanjing, China
Dallas, Texas, United States
Recife, Pernambuco, Brazil
Wuhan, Hubei, China
Xiamen, China
Aalborg, Denmark
Copenhagen Oe, Denmark
Giessen, Hessen, Germany
Piraeus, Greece
Essen, North Rhine Westphalia, Germany
Nürnberg, Germany
Tainan, Taiwan
Taipei, Taiwan
Nuevo León, Mexico
Rivne, Ukraine
Torquay, Devon, United Kingdom
Cardiff, United Kingdom
Edegem, Belgium
New Hyde Park, New York, United States
Beijing, China
Pittsburgh, Pennsylvania, United States
Tampa, Florida, United States
Saint Herblain, France
Suresnes, France
Atlanta, Georgia, United States
Mexico, Distrito Federal, Mexico
Lodz, Poland
Helsinki, Finland
Rivne, Ukraine
Barretos, Sao Paulo, Brazil
Nantes, France
Nice, France
Herning, Denmark
Turku, Finland
Odense, Denmark
Meldola, Emilia Romagna, Italy
Aviano, Friuli Venezia Giulia, Italy
Chaidari, Greece
Verona, Italy
Subang Jaya, Selangor, Malaysia
Taipei, Taiwan
Orbassano, Piemonte, Italy
Taipei, Taiwan
Padova, Veneto, Italy
Linyi, China
Guangzhou, China
Zlin, Zlinsky Kraj, Czechia
Bauru, Brazil
Blumenau, Santa Catarina, Brazil
Ostrava Vítkovice, Czechia
Atlanta, Georgia, United States
New Hyde Park, New York, United States
Columbus, Georgia, United States
Valencia, Spain
Portland, Oregon, United States
Richmond, Virginia, United States
Sofia, Bulgaria
Farmington Hills, Michigan, United States
Athens, Greece
Petaling Jaya, Selangor, Malaysia
Turku, Finland
Shah Alam, Selangor, Malaysia
Athens, Greece
Shanghai, China
Majadahonda, Madrid, Spain
Helsinki, Finland
Roma, Lazio, Italy
Barcelona, Spain
Madrid, Spain
Avellino, Campania, Italy
Royal Oak, Michigan, United States
George Town,, Malaysia
Milano, Lombardia, Italy
Miramar, Florida, United States
Pamplona, Spain
San Francisco, California, United States
Salzburg, Austria
Nanning, China
Salzburg, Austria
Yuregir, Turkey
Brampton, Ontario, Canada
Suresnes, France
Beijing, Beijing, China
Villejuif Cedex, France
Jerusalem, Israel
Harbin, Heilongjiang, China
Athens, Greece
Taizhou, Zhejiang, China
Niigata, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Kitaadachi Gun, Saitama, Japan
Yonago, Tottori, Japan
Otwock, Poland
Poznan, Poland
Wien, Austria
Leuven, Vlaams Brabant, Belgium
Wien, Austria
Chaidari, Greece
Roeselare, West Flanders, Belgium
Tel Aviv, Israel
Bologna, Emilia Romagna, Italy
Newport Beach, California, United States
Montreal, Quebec, Canada
Wuhan, Hubei, China
Hangzhou, Zhejiang, China
Athens, Greece
Heidelberg, Australia
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, Brazil
Fuzhou, Fujian, China
Changsha, Hunan, China
Beijing, China
Wuhan, China
Guangzhou, China
Hangzhou, China
Harbin, China
København ø, Denmark
Hong Kong, Hong Kong
Forlì Cesena, Emilia Romagna, Italy
Avellino, Campania, Italy
Bologna, Emilia Romagna, Italy
Roma, Lazio, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Padova, Veneto, Italy
Matosinhos, Portugal
Subang Jaya, Malaysia
Singapore, Singapore
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Kaohsiung, Taiwan
Kiev, Ukraine
Pamplona, Spain
Poprad, Slovakia
Barcelona, Spain
Ostrava, Czechia
Taipei, Taiwan
Yüregir, Turkey
Essen, North Rhine Westphalia, Germany
Hirakata, Osaka, Japan
Osakasayama, Osaka, Japan
Nuevo León, Mexico
Dnipropetrovsk, Ukraine
Panagyurishte, Pazardzhik, Bulgaria
Sofia, Bulgaria
Kobe, Hyogo, Japan
Antwerpen, Belgium
Sagamihara, Kanagawa, Japan
Blumenau, Brazil
Flore?Ti, Comuna Floresti, Romania
Köln, Nordrhein Westfalen, Germany
Olomouc, Czechia
Ashdod, Israel
Cheras, Malaysia
Bucuresti, Romania
Baden, Aargau, Switzerland
Buderim, Australia
Shah Alam, Malaysia
Wuhan, China
Istanbul, Turkey
Xiamen, China
Linyi, China
Tainan, Taiwan
Toronto, Ontario, Canada
Montreal, Canada
Garran, Australia
Antwerpen, Belgium
Vancouver, Canada
Leuven, Belgium
Nanjing, Jiangsu, China
Beijing, China
Aalborg, Denmark
Herning, Denmark
København ø, Denmark
Roeselare, Belgium
Odense, Denmark
Turku, Finland
Porto Alegre, Rio Grande Do Sul, Brazil
Bordeaux, France
Montpellier, France
Osakasayama Shi, Japan
Mulhouse, France
Sapporo, Japan
Paris, France
Seoul, Korea, Republic Of
México, Distrito Federal, Mexico
Cdmx, Mexico
Naucalpan, Mexico
San Pedro Garza García, Mexico
Nijmegen, Netherlands
Kielce, Poland
Lodz, Poland
Matosinhos, Porto, Portugal
Ube, Japan
Cheongju Si, Chungcheongbugdo, Korea, Republic Of
Yangsan Si, Gyeongsangnamdo, Korea, Republic Of
Barcelona, Spain
Barcelona, Spain
Madrid, Spain
Gwangju, Korea, Republic Of
Baden, Switzerland
Jinju Si, Korea, Republic Of
Kadikoy, Turkey
Seoul, Korea, Republic Of
Jinan, China
Kucukcekmece, Turkey
Shanghai, China
Sakarya, Turkey
Aarhus N, Denmark
Yenimahalle, Turkey
Madrid, Spain
Torquay, United Kingdom
Valencia, Spain
Valencia, Spain
Taichung, Taiwan
Kaohsiung City, Kaohsiung, Taiwan
Liverpool, New South Wales, Australia
Lund, Sweden
Umeå, Sweden
Barretos, Brazil
Recife, Brazil
Thessaloniki, Greece
Sao Paulo, Brazil
Thessaloniki, Greece
Sao Paulo, Brazil
Ashdod, Israel
Sao Paulo, Brazil
Be'er Sheva, Israel
Pordenone, Friuli Venezia Giulia, Italy
Panagyurishte, Bulgaria
Roma, Lazio, Italy
Pleven, Bulgaria
Milano, Lombardia, Italy
Forlì Cesena, Italy
Milano, Lombardia, Italy
Roma, Italy
Verona, Italy
Milano, Lombardia, Italy
Torino, Piemonte, Italy
Padova, Veneto, Italy
Avellino, Italy
Nagoya, Aichi, Japan
Bologna, Italy
Himeji, Hyogo, Japan
A Coruna, Spain
Badalona, Spain
Sagamihara, Kanagawa, Japan
Sendai, Miyagi, Japan
Barcelona, Spain
Bunkyo Ku, Japan
Fukuoka Shi, Japan
Hirakata, Japan
Kashiwa, Japan
Kobe, Japan
Pierre Bénite, France
Osaka Shi, Japan
Brest, France
Comuna Floresti, Romania
Créteil, France
Singapore, Singapore
Singapore, Singapore
Lille, France
Barañaín, Navarra, Spain
Limoges, France
Paris, France
Hollywood, Florida, United States
Nanjing, China
Nanning, China
Houston, Texas, United States
Newport Beach, California, United States
La Tronche, France
Tampa, Florida, United States
Blacktown, New South Wales, Australia
Lille, France
Limoges, France
Montpellier, France
Mulhouse, France
Seoul, Korea, Republic Of
Puebla, Mexico
Uzhhorod, Ukraine
Paris, France
Paris, France
Villejuif Cedex, France
Taipei, Taiwan
Bunkyo Ku, Tokyo, Japan
Pierre Bénite, France
Rouen, France
Frankfurt, Germany
Buenos Aires, Argentina
São José Do Rio Preto, Sao Paulo, Brazil
Concord, New South Wales, Australia
Brampton, Ontario, Canada
Córdoba, Argentina
Beijing, China
Brest, France
Roma, Lazio, Italy
Tbc, Argentina
Waratah, New South Wales, Australia
Gießen, Hessen, Germany
København ø, Denmark
Köln, Nordrhein Westfalen, Germany
Petaling Jaya, Selangor, Malaysia
Jinju Si, Gyeongsangnam Do, Korea, Republic Of
San Diego, California, United States
Copenhagen, Denmark
Hwasun Gun, Korea, Republic Of
Kuala Lumpur, Malaysia
Kiev, Ukraine
Odense C, Denmark
Kirovograd, Ukraine
Hong Kong, Hong Kong
Lutsk, Ukraine
Kyiv, Ukraine
Padova, Veneto, Italy
Bucuresti, Romania
Varna, Bulgaria
Craiova, Romania
Craiova, Romania
Natal, Rio Grande Do Norte, Brazil
Vancouver, Canada
La Tronche, France
Paris Cedex 5, France
Singapore, Singapore
Osaka, Japan
Singapore, Singapore
Amsterdam, Netherlands
Rozzano, Lombardia, Italy
Cluj Napoca, Romania
Beijing, China
Bordeaux Cedex, France
Cluj Napoca, Romania
Sofia, Bulgaria
Budapest, Hungary
Rouen, France
Saint Herblain, France
Porto, Portugal
Fukuoka, Japan
Tainan, Tnn, Taiwan
San Diego, California, United States
Belfast, North Ireland, United Kingdom
San Francisco, California, United States
Santa Monica, California, United States
Guildford, Surrey, United Kingdom
Seoul, Korea, Republic Of
Coimbra, Portugal
Vancouver, British Columbia, Canada
Madrid, Spain
Beijing, Beijing, China
Changsha, Hunan, China
Hangzhou, Zhejiang, China
Nanjing, China
Shanghai, China
Montpellier, France
Nový Jicín, Czechia
Berlin, Germany
Villejuif, France
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Firenze, Italy
Lecce, Italy
Fort Lauderdale, Florida, United States
Milano, Italy
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
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