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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 02, 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

Belfast, North Ireland, United Kingdom

Chicago, Illinois, United States

Minneapolis, Minnesota, United States

Beijing, Beijing, China

Shanghai, Shanghai, China

Kyiv, Ukraine

Uzhgorod, Ukraine

Fortaleza, Brazil

Orlando, Florida, United States

Tainan, Taiwan

Caba, Ciudad Auton. De Buenos Aires, Argentina

Adana, Turkey

Bilkent çankaya, Turkey

Istanbul, Turkey

Chicago, Illinois, United States

Lisboa, Portugal

Izmir, Turkey

Athens, Greece

Palermo, Italy

Varese, Italy

Farmington Hills, Michigan, United States

Lisboa, Portugal

Hangzhou, Zhejiang, China

Viedma, Argentina

Porto Alegre Rs, Rio Grande Do Sul, Brazil

Chengdu, Sichuan, China

Olomouc, Czechia

Ostrava Vitkovice, Czechia

Taizhou, China

Stuttgart, Germany

Zlin, Czechia

Hong Kong, Hong Kong

Tatabanya, Hungary

Kowloon, Hong Kong

Bialystok, Poland

Bucharest, Romania

Shatin, Hong Kong

Flore¿Ti, Romania

Singapore, Singapore

Poprad, Slovakia

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Brno, Czechia

Novy Jicin, Czechia

Essen, Germany

Nürnberg, Germany

Trnava, Slovakia

Santa Monica, California, United States

Budapest, Hungary

Taichung, Taiwan

Sakarya, Turkey

Tainan, Taiwan

Whittier, Florida, United States

Wroclaw, Poland

Changchun, Jilin, China

Chengdu, China

Beijing, China

Hong Kong, Hong Kong

Villejuif Cedex, France

Ube, Yamaguchi, Japan

Matosinhos, Porto, Portugal

Bordeaux, France

Créteil, France

Madrid, Spain

Cincinnati, Ohio, United States

Coimbra, Portugal

Harbin, China

Nanjing, China

Perai, Malaysia

Xiamen, China

Aalborg, Denmark

Dallas, Texas, United States

Copenhagen Oe, Denmark

Recife, Pernambuco, Brazil

Giessen, Hessen, Germany

Essen, North Rhine Westphalia, Germany

Nürnberg, Germany

Piraeus, Greece

Tainan, Taiwan

Wuhan, Hubei, China

Taipei, Taiwan

Nuevo León, Mexico

Torquay, Devon, United Kingdom

Rivne, Ukraine

Edegem, Belgium

Beijing, China

Cardiff, United Kingdom

Saint Herblain, France

Suresnes, France

Tampa, Florida, United States

New Hyde Park, New York, United States

Pittsburgh, Pennsylvania, United States

Atlanta, Georgia, United States

Helsinki, Finland

Mexico, Distrito Federal, Mexico

Lodz, Poland

Rivne, Ukraine

Nantes, France

Nice, France

Herning, Denmark

Odense, Denmark

Barretos, Sao Paulo, Brazil

Chaidari, Greece

Turku, Finland

Aviano, Friuli Venezia Giulia, Italy

Meldola, Emilia Romagna, Italy

Verona, Italy

Orbassano, Piemonte, Italy

Padova, Veneto, Italy

Taipei, Taiwan

Subang Jaya, Selangor, Malaysia

Taipei, Taiwan

Guangzhou, China

Bauru, Brazil

Atlanta, Georgia, United States

Linyi, China

New Hyde Park, New York, United States

Zlin, Zlinsky Kraj, Czechia

Valencia, Spain

Blumenau, Santa Catarina, Brazil

Columbus, Georgia, United States

Ostrava Vítkovice, Czechia

Farmington Hills, Michigan, United States

Turku, Finland

Portland, Oregon, United States

Richmond, Virginia, United States

Sofia, Bulgaria

Athens, Greece

Athens, Greece

Petaling Jaya, Selangor, Malaysia

Shah Alam, Selangor, Malaysia

Shanghai, China

Helsinki, Finland

Majadahonda, Madrid, Spain

Roma, Lazio, Italy

Barcelona, Spain

Royal Oak, Michigan, United States

George Town,, Malaysia

Madrid, Spain

Pamplona, Spain

Avellino, Campania, Italy

Milano, Lombardia, Italy

San Francisco, California, United States

Salzburg, Austria

Salzburg, Austria

Brampton, Ontario, Canada

Miramar, Florida, United States

Beijing, Beijing, China

Nanning, China

Yuregir, Turkey

Suresnes, France

Villejuif Cedex, France

Jerusalem, Israel

Harbin, Heilongjiang, China

Taizhou, Zhejiang, China

Athens, Greece

Niigata, Japan

Kitaadachi Gun, Saitama, Japan

Yonago, Tottori, Japan

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Otwock, Poland

Poznan, Poland

Wien, Austria

Wien, Austria

Leuven, Vlaams Brabant, Belgium

Roeselare, West Flanders, Belgium

Chaidari, Greece

Montreal, Quebec, Canada

Tel Aviv, Israel

Bologna, Emilia Romagna, Italy

Wuhan, Hubei, China

Hangzhou, Zhejiang, China

Athens, Greece

Heidelberg, Australia

Porto Alegre, Rio Grande Do Sul, Brazil

Newport Beach, California, United States

Fuzhou, Fujian, China

Changsha, Hunan, China

Beijing, China

Sao Paulo, Brazil

Wuhan, China

Guangzhou, China

København ø, Denmark

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

Roma, Lazio, Italy

Singapore, Singapore

Poprad, Slovakia

Barcelona, Spain

Milano, Lombardia, Italy

Milano, Lombardia, Italy

Kaohsiung, Taiwan

Kiev, Ukraine

Pamplona, Spain

Padova, Veneto, Italy

Kashiwa, Chiba, Japan

Sapporo, Hokkaido, Japan

Essen, North Rhine Westphalia, Germany

Hirakata, Osaka, Japan

Osakasayama, Osaka, Japan

Nuevo León, Mexico

Ostrava, Czechia

Taipei, Taiwan

Panagyurishte, Pazardzhik, Bulgaria

Sofia, Bulgaria

Yüregir, Turkey

Kobe, Hyogo, Japan

Sagamihara, Kanagawa, Japan

Flore?Ti, Comuna Floresti, Romania

Dnipropetrovsk, Ukraine

Olomouc, Czechia

Köln, Nordrhein Westfalen, Germany

Ashdod, Israel

Antwerpen, Belgium

Cheras, Malaysia

Blumenau, Brazil

Bucuresti, Romania

Baden, Aargau, Switzerland

Shah Alam, Malaysia

Buderim, Australia

Istanbul, Turkey

Wuhan, China

Tainan, Taiwan

Linyi, China

Xiamen, China

Garran, Australia

Antwerpen, Belgium

Leuven, Belgium

Toronto, Ontario, Canada

Montreal, Canada

Roeselare, Belgium

Porto Alegre, Rio Grande Do Sul, Brazil

Montpellier, France

Vancouver, Canada

Nanjing, Jiangsu, China

Beijing, China

Aalborg, Denmark

Mulhouse, France

Herning, Denmark

København ø, Denmark

Paris, France

Odense, Denmark

Turku, Finland

Osakasayama Shi, Japan

Sapporo, Japan

Ube, Japan

Bordeaux, France

Seoul, Korea, Republic Of

México, Distrito Federal, Mexico

Cdmx, Mexico

Cheongju Si, Chungcheongbugdo, Korea, Republic Of

Naucalpan, Mexico

San Pedro Garza García, Mexico

Nijmegen, Netherlands

Kielce, Poland

Lodz, Poland

Matosinhos, Porto, Portugal

Barcelona, Spain

Yangsan Si, Gyeongsangnamdo, Korea, Republic Of

Barcelona, Spain

Madrid, Spain

Baden, Switzerland

Kadikoy, Turkey

Gwangju, Korea, Republic Of

Kucukcekmece, Turkey

Sakarya, Turkey

Jinju Si, Korea, Republic Of

Seoul, Korea, Republic Of

Jinan, China

Yenimahalle, Turkey

Shanghai, China

Torquay, United Kingdom

Aarhus N, Denmark

Madrid, Spain

Valencia, Spain

Valencia, Spain

Lund, Sweden

Taichung, Taiwan

Umeå, Sweden

Kaohsiung City, Kaohsiung, Taiwan

Liverpool, New South Wales, Australia

Recife, Brazil

Sao Paulo, Brazil

Barretos, Brazil

Sao Paulo, Brazil

Sao Paulo, Brazil

Panagyurishte, Bulgaria

Thessaloniki, Greece

Thessaloniki, Greece

Pleven, Bulgaria

Forlì Cesena, Italy

Ashdod, Israel

Be'er Sheva, Israel

Roma, Italy

Pordenone, Friuli Venezia Giulia, Italy

Verona, Italy

Roma, Lazio, Italy

Nagoya, Aichi, Japan

Milano, Lombardia, Italy

Himeji, Hyogo, Japan

Sagamihara, Kanagawa, Japan

Milano, Lombardia, Italy

Milano, Lombardia, Italy

Sendai, Miyagi, Japan

Bunkyo Ku, Japan

Fukuoka Shi, Japan

Hirakata, Japan

Kashiwa, Japan

Torino, Piemonte, Italy

Padova, Veneto, Italy

Avellino, Italy

Bologna, Italy

Kobe, Japan

Osaka Shi, Japan

A Coruna, Spain

Badalona, Spain

Comuna Floresti, Romania

Barcelona, Spain

Pierre Bénite, France

Singapore, Singapore

Brest, France

Créteil, France

Lille, France

Limoges, France

Paris, France

Nanjing, China

Nanning, China

Singapore, Singapore

Barañaín, Navarra, Spain

Hollywood, Florida, United States

Houston, Texas, United States

La Tronche, France

Newport Beach, California, United States

Tampa, Florida, United States

Lille, France

Blacktown, New South Wales, Australia

Seoul, Korea, Republic Of

Puebla, Mexico

Limoges, France

Montpellier, France

Mulhouse, France

Paris, France

Uzhhorod, Ukraine

Paris, France

Villejuif Cedex, France

Taipei, Taiwan

Bunkyo Ku, Tokyo, Japan

Pierre Bénite, France

Rouen, France

Buenos Aires, Argentina

Frankfurt, Germany

Concord, New South Wales, Australia

Brampton, Ontario, Canada

Beijing, China

Brest, France

Roma, Lazio, Italy

Córdoba, Argentina

Tbc, Argentina

Waratah, New South Wales, Australia

São José Do Rio Preto, Sao Paulo, Brazil

Gießen, Hessen, Germany

Köln, Nordrhein Westfalen, Germany

København ø, Denmark

Petaling Jaya, Selangor, Malaysia

Jinju Si, Gyeongsangnam Do, Korea, Republic Of

Hwasun Gun, Korea, Republic Of

Kuala Lumpur, Malaysia

San Diego, California, United States

Copenhagen, Denmark

Odense C, Denmark

Hong Kong, Hong Kong

Padova, Veneto, Italy

Kiev, Ukraine

Kirovograd, Ukraine

Kyiv, Ukraine

Bucuresti, Romania

Craiova, Romania

Lutsk, Ukraine

Craiova, Romania

Singapore, Singapore

Singapore, Singapore

Natal, Rio Grande Do Norte, Brazil

Vancouver, Canada

La Tronche, France

Paris Cedex 5, France

Varna, Bulgaria

Osaka, Japan

Beijing, China

Amsterdam, Netherlands

Rozzano, Lombardia, Italy

Cluj Napoca, Romania

Cluj Napoca, Romania

Sofia, Bulgaria

Bordeaux Cedex, France

Budapest, Hungary

Rouen, France

Fukuoka, Japan

San Diego, California, United States

Saint Herblain, France

San Francisco, California, United States

Porto, Portugal

Santa Monica, California, United States

Vancouver, British Columbia, Canada

Tainan, Tnn, Taiwan

Beijing, Beijing, China

Changsha, Hunan, China

Belfast, North Ireland, United Kingdom

Hangzhou, Zhejiang, China

Guildford, Surrey, United Kingdom

Shanghai, China

Montpellier, France

Seoul, Korea, Republic Of

Villejuif, France

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Coimbra, Portugal

Madrid, Spain

Fort Lauderdale, Florida, United States

Nanjing, China

Nový Jicín, Czechia

Berlin, Germany

Firenze, Italy

Lecce, Italy

Milano, Italy

Chicago, Illinois, United States

Baltimore, Maryland, United States

Worcester, Massachusetts, United States

Cincinnati, Ohio, United States

Chicago, Illinois, 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