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