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Search / Trial NCT06452277

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

Nsclc Erbb2 Mutation

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported