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