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Um estudo para testar diferentes doses de BI 1810631 em pessoas com diferentes tipos de câncer avançado (tumores sólidos com alterações no gene HER2)

27 de outubro de 2026 atualizado por: Boehringer Ingelheim

Um teste de escalonamento de dose de rótulo aberto, fase I, com confirmação de dose e expansão, de BI 1810631 como monoterapia em pacientes com tumores sólidos avançados ou metastáticos com aberrações HER2

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.

The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.

The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.

In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.

The participants are in the study for as long as they benefit from and can tolerate treatment.

Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

554

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Additional US locations available on demand. Please contact for options.
  • Número de telefone: 1-800-243-0127

Estude backup de contato

Locais de estudo

  • Alemanha
      • Augsburg, Alemanha, 86156
        • Concluído
        • Universitätsklinikum Augsburg
      • Cologne, Alemanha, 50937
        • Recrutamento
        • Universitätsklinikum Köln (AöR)
        • Contato:
      • Dresden, Alemanha, 01307
      • Giessen, Alemanha, 35392
        • Recrutamento
        • Justus-Liebig Universität Gießen
        • Contato:
      • Oldenburg, Alemanha, 26121
  • Austrália
    • New South Wales
      • Macquarie Park, New South Wales, Austrália, 2109
        • Concluído
        • Macquarie University
  • Bélgica
      • Anderlecht/Brussels-Capital, Bélgica, 1070
        • Ativo, não recrutando
        • Brussels - HOSP Jules Bordet
  • China
      • Beijing, China, 100036
        • Concluído
        • Beijing Cancer Hospital
      • Changchun, China, 130021
        • Ativo, não recrutando
        • The First Hospital of Jilin University
      • Changchun, China, 130012
        • Concluído
        • Jilin Province Cancer Hospital
      • Fuzhou, China, 350014
        • Ativo, não recrutando
        • Fujian Cancer Hospital
      • Guangzhou, China, 510080
        • Ativo, não recrutando
        • Guangdong Provincial People's Hospital
      • Hangzhou, China, 310022
        • Ativo, não recrutando
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310003
        • Ativo, não recrutando
        • The First Affiliated Hospital, Zhejiang University
      • Harbin, China, 150081
        • Ativo, não recrutando
        • Harbin Medical University Cancer Hospital
      • Nanning, China, 530021
        • Concluído
        • The Affiliated Cancer Hospital, Guangxi Medical University
      • Shanghai, China, 200030
        • Concluído
        • Shanghai Chest Hospital
      • Wuhan, China, 430030
        • Ativo, não recrutando
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
      • Wuhan, China, 430022
        • Ativo, não recrutando
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xiamen, China, 361003
        • Concluído
        • First Affiliated Hospital of Xiamen University
      • Zhengzhou, China, 450052
        • Ativo, não recrutando
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, China, 450008
        • Ativo, não recrutando
        • Henan Cancer Hospital
  • Cingapura
      • Singapore, Cingapura, 169610
        • Recrutamento
        • National Cancer Centre Singapore
        • Contato:
      • Singapore, Cingapura, 119228
        • Concluído
        • National University Hospital-Singapore-22806
  • Coréia do Sul
      • Chungju, Coréia do Sul, 28644
        • Recrutamento
        • Chungbuk National University Hospital
        • Contato:
      • Seongnam, Coréia do Sul, 13620
        • Recrutamento
        • Seoul National University Bundang Hospital
        • Contato:
      • Seoul, Coréia do Sul, 05505
        • Recrutamento
        • Asan Medical Center
        • Contato:
      • Seoul, Coréia do Sul, 06351
        • Recrutamento
        • Samsung Medical Center
        • Contato:
      • Seoul, Coréia do Sul, 03722
        • Ativo, não recrutando
        • Severance Hospital
  • Espanha
      • Barcelona, Espanha, 08035
        • Ativo, não recrutando
        • Hospital Universitari Vall d'Hebron
      • L'Hospitalet de Llobregat, Espanha, 08907
        • Ativo, não recrutando
        • Hospital Duran i Reynals
      • Madrid, Espanha, 28041
        • Ativo, não recrutando
        • Hospital Universitario 12 de Octubre
      • Madrid, Espanha, 28007
        • Concluído
        • Hospital General Universitario Gregorio Marañón
      • Málaga, Espanha, 29010
        • Ativo, não recrutando
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Espanha, 46010
        • Ativo, não recrutando
        • Hospital Clinico Universitario de Valencia
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
    • California
      • Beverly Hills, California, Estados Unidos, 90212
        • Concluído
        • Precision NextGen Oncology
      • Duarte, California, Estados Unidos, 91010
      • Huntington Beach, California, Estados Unidos, 92648
        • Concluído
        • City of Hope - Seacliff
      • Irvine, California, Estados Unidos, 92618
        • Concluído
        • City of Hope-Irvine-69674
      • Los Angeles, California, Estados Unidos, 90067
      • Orange, California, Estados Unidos, 92868
      • Sacramento, California, Estados Unidos, 95817
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20007
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Recrutamento
        • Holy Cross Hospital-Fort Lauderdale-57892
        • Contato:
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
    • New York
      • New York, New York, Estados Unidos, 10016
        • Recrutamento
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • Contato:
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Recrutamento
        • Sarah Cannon Research Institute-Nashville-48456
        • Contato:
    • Texas
      • Dallas, Texas, Estados Unidos, 75230
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • The University of Texas MD Anderson Cancer Center
        • Contato:
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Recrutamento
        • Fred Hutchinson Cancer Research Center
        • Contato:
  • França
      • Bron, França, 69677
        • Ativo, não recrutando
        • Hopital Louis Pradel
      • Lyon, França, 69373
        • Ativo, não recrutando
        • CTR Leon Berard
      • Marseille, França, 13385
        • Ativo, não recrutando
        • HOP Timone
      • Paris, França, 75005
        • Ativo, não recrutando
        • INS Curie
      • Rennes, França, 35000
        • Ativo, não recrutando
        • HOP Pontchaillou
      • Villejuif, França, 94805
        • Ativo, não recrutando
        • Institut Gustave Roussy
  • Holanda
      • Amsterdam, Holanda, 1066 CX
        • Recrutamento
        • Nederlands Kanker Instituut
        • Contato:
      • Leiden, Holanda, 2333 ZA
        • Ativo, não recrutando
        • Leids Universitair Medisch Centrum (LUMC)
  • Hong Kong
      • Hong Kong, Hong Kong
        • Ativo, não recrutando
        • Queen Mary Hospital
      • Hong Kong, Hong Kong, 999077
        • Ativo, não recrutando
        • Prince of Wales Hospital-Hong Kong-20715
  • Israel
      • Haifa, Israel, 3109601
        • Concluído
        • Rambam Medical Center
      • Kfar Saba, Israel, 44281
        • Ativo, não recrutando
        • Meir Medical Center
      • Tel Aviv, Israel, 6423906
        • Ativo, não recrutando
        • Sourasky Medical Center
      • Tel HaShomer, Israel, 52621
        • Concluído
        • The Chaim Sheba Medical Center Tel HaShomer
  • Itália
      • Candiolo (TO), Itália, 10060
        • Concluído
        • Istituto Di Candiolo
      • Naples, Itália, 80131
        • Concluído
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
      • Parma, Itália, 43100
        • Concluído
        • Azienda Ospedaliera Unversitaria di Parma
  • Japão
      • Chiba, Kashiwa, Japão, 277-8577
        • Recrutamento
        • National Cancer Center Hospital East
        • Contato:
      • Ehime, Matsuyama, Japão, 791-0280
        • Recrutamento
        • Shikoku Cancer Center
        • Contato:
      • Hiroshima, Hiroshima, Japão, 734-8551
        • Recrutamento
        • Hiroshima University Hospital
        • Contato:
      • Osaka, Osaka, Japão, 541-8567
        • Recrutamento
        • Osaka International Cancer Institute
        • Contato:
      • Osaka, Sakai, Japão, 590-0197
        • Recrutamento
        • Kindai University Hospital
        • Contato:
      • Shizuoka, Hamamatsu, Japão, 431-3192
        • Recrutamento
        • Hamamatsu University Hospital
        • Contato:
      • Tokyo, Chuo-ku, Japão, 104-0045
        • Recrutamento
        • National Cancer Center Hospital
        • Contato:
  • Portugal
      • Porto, Portugal, 4100-180
        • Concluído
        • Hospital CUF Porto
  • Reino Unido
      • London, Reino Unido, SW3 6JJ
        • Ativo, não recrutando
        • The Royal Marsden Hospital, Chelsea
      • London, Reino Unido, W12 0HS
        • Ativo, não recrutando
        • Hammersmith Hospital
      • Sutton, Reino Unido, SM2 5PT
        • Ativo, não recrutando
        • The Royal Marsden Hospital, Sutton
  • Suécia
      • Stockholm, Suécia, 171 76
        • Concluído
        • Karolinska Universitetssjukhuset Solna
  • Áustria
      • Linz, Áustria, 4020
        • Concluído
        • Ordensklinikum Linz GmbH

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) .

  • Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.

  • Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).

  • Adequate organ function defined as all of the following:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (≥ 1.5 x 10^3/μL) (≥ 1500/mm^3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 10^9/L (100 x 10^3/μL) (100 x 10^3/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication.
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
    • Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula (≥ 30 mL/min/1.73m² for cohorts 6, 8, and 9).
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
    • Alkaline Phosphatase < 5 x ULN.

  • Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2)

  • Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.

  • At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.

  • Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

  • Male or female patients. Women of childbearing potential (WOCBP) and men who are able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Additional inclusion criteria for Phase Ia

  • Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)
  • Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease

Additional inclusion criteria for Phase Ib - Cohort 1 only

  • Non-squamous non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with non-squamous NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.

Additional inclusion criteria for Phase Ib - Cohort 2 only

  • Non-squamous NSCLC patient with a documented HER2 mutation in the tyrosine kinase domain (TKD) as per local lab results.
  • Treatment naïve for non-squamous NSCLC.

Additional inclusion criteria for Phase Ib - Cohort 3 only

  • NSCLC Patient with a documented HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results or squamous NSCLC patient with mutation in the TKD as per local lab results. After implementation of CTP v8, only non-squamous NSCLC patients with a documented activating HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy. After implementation of CTP v8, patients who had received, in the advanced/metastatic setting, at least one line of systemic therapy OR patients who are treatment naïve for non-squamous NSCLC (no prior systemic therapy, immunotherapy or targeted therapy for stage IIIB or IV adenocarcinoma).

Additional inclusion criteria for Phase Ib - Cohort 4 only

  • NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
  • NSCLC patients who are either treatment naïve or who had received any prior line of treatment, in the advanced/metastatic setting. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.
  • Patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.

Additional inclusion criteria for Phase Ib - Cohort 5 only

  • Non-squamous NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
  • Patient should have received, in the advanced/metastatic setting, at least one line of systemic therapy that includes a platinum-based combination chemotherapy and should have been treated with previous HER2 directed antibody-drug conjugates (ADC) in the same advanced/metastatic setting and developed disease progression recurrence during or after completing this therapy. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.

Additional inclusion criteria for Phase Ib - Cohort 6 only

  • Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
  • Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
  • Patient who is not eligible for any other recruiting cohort.

Additional inclusion criteria for Phase Ib - Cohort 7 only

  • Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
  • Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
  • Patient who is not eligible for any other recruiting cohort.

Additional inclusion criteria for Phase Ib - Cohort 8 only

  • Treatment naïve for NSCLC
  • NSCLC (adenocarcinoma or squamous) patient with documented HER2 mutation in the tyrosine kinase domain (TKD) or non-squamous NSCLC with a documented HER2 mutation in the non tyrosine kinase domain (non TKD) as per local lab results

Additional inclusion criteria for Phase Ib - Cohort 9 only

  • Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.

Further inclusion criteria apply.

Exclusion Criteria:

  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening

  • Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except:

    • effectively treated non-melanoma skin cancers
    • effectively treated carcinoma in situ of the cervix
    • effectively treated ductal carcinoma in situ
    • other effectively treated malignancy that is considered cured by local treatment.

  • Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication

  • Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial

  • Previous treatment with zongertinib.

  • Radiotherapy within 2 weeks prior to first study treatment, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week prior to first study treatment.

Further exclusion criteria apply.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Fase Ib - Parte da expansão da dose: Coorte 1
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Fase Ib - Parte da expansão da dose: Coorte 2
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Fase Ib - Parte da expansão da dose: Coorte 3
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Fase Ib - Parte da expansão da dose: Coorte 4
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Fase Ib - Parte da expansão da dose: Coorte 5
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Phase Ia - Dose escalation part

Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Phase Ib - Dose expansion part: Cohort 6

Cohort only in the United States of America (USA)
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Phase Ib - Dose expansion part: Cohort 7

Cohort only in Japan
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Phase Ib - Dose expansion part: Cohort 8

Cohort only in the United States of America (USA)
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®
Experimental: Phase Ib - Dose expansion part: Cohort 9

Cohort only in China
Medicamento: zongertinib

zongertinib

Outros nomes:
  • BI 1810631, Hernexeos®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fase Ia: Número de pacientes com Toxicidades Limitantes de Dose (DLTs) no período de avaliação MTD
Prazo: No final do Ciclo 1 (cada ciclo tem 21 dias).
No final do Ciclo 1 (cada ciclo tem 21 dias).
Fase Ib: Coorte 4: Resposta objetiva de acordo com a avaliação de resposta em neuro-oncologia para metástases cerebrais (RANO-BM) por revisão independente central
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Phase Ia: Maximum Tolerated Dose (MTD)
Prazo: At the end of Cycle 1 (each cycle is 21 days).

Maximum tolerated dose is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period in any studied regimen.
At the end of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response (OR) as assessed by central independent review
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.

OR is defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (patients prior to CTP v8.0), 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.

Clincal Trial Protocol version 8.0 = CTP v8.0
From the start of the trial treatment until end of month 12, up to 12 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Fase Ia: Número de pacientes com DLTs durante todo o período de tratamento
Prazo: Desde o início do tratamento experimental até o final do mês 8, até 8 meses.
Desde o início do tratamento experimental até o final do mês 8, até 8 meses.
Fase Ib - Coorte 4: Duração da resposta objetiva (DoR) de acordo com RANO-BM por revisão independente central
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Coorte 4: Controle da doença (DC) de acordo com RANO-BM por revisão independente central
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Coorte 4: Sobrevida livre de progressão (PFS) de acordo com RANO-BM conforme avaliado por revisão independente central
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Coorte 4: OU de acordo com RECIST 1.1 por revisão central independente
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Coorte 4: Duração do OR de acordo com RECIST 1.1 por revisão central independente
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Coorte 4: DC de acordo com RECIST 1.1 por revisão central independente
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Todas as Coortes: Número de pacientes com DLTs durante todo o período de tratamento
Prazo: Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Desde o início do tratamento experimental até o final do mês 12, até 12 meses.
Fase Ib - Todas as Coortes: Alteração desde a linha de base até o Dia 1 do Ciclo 5 no questionário básico de qualidade de vida do EORTC (EORTC QLQ-C30) pontuação do domínio do funcionamento físico
Prazo: Linha de base e no dia 1 do ciclo 5 (cada ciclo é de 21 dias).
Linha de base e no dia 1 do ciclo 5 (cada ciclo é de 21 dias).
Fase Ib - Todas as Coortes: Mudança da linha de base para o Dia 1 do Ciclo 5 na pontuação total do Questionário de Avaliação de Sintomas de Câncer de Pulmão de Células Não Pequenas (NSCLC-SAQ)
Prazo: Linha de base e no dia 1 do ciclo 5 (cada ciclo é de 21 dias).
Linha de base e no dia 1 do ciclo 5 (cada ciclo é de 21 dias).
Fase Ib - Todas as Coortes: Mudança da linha de base para o Dia 1 do Ciclo 5 na pontuação da Lista 46 (IL46) do item EORTC
Prazo: Linha de base e no dia 1 do ciclo 5 (cada ciclo é de 21 dias).
Linha de base e no dia 1 do ciclo 5 (cada ciclo é de 21 dias).
Fase Ia: Concentração máxima medida de zongertinib no plasma (Cmax)
Prazo: No dia 1 e no dia 15 do Ciclo 1 (cada ciclo dura 21 dias).
No dia 1 e no dia 15 do Ciclo 1 (cada ciclo dura 21 dias).
Fase Ia: Área sob a curva concentração-tempo de zongertinib no plasma (AUC0-t2)
Prazo: No dia 1 e no dia 15 do Ciclo 1 (cada ciclo dura 21 dias).
No dia 1 e no dia 15 do Ciclo 1 (cada ciclo dura 21 dias).
Fase Ib - Todas as coortes: Sobrevida global (SG), definida como o tempo desde a primeira administração do tratamento até a morte por qualquer causa
Prazo: Desde o início do tratamento experimental até o final do 12º mês, até 12 meses.
Desde o início do tratamento experimental até o final do 12º mês, até 12 meses.
Fase IB - Coorte 4: PFS de acordo com Recist 1.1 pela Central Independent Review
Prazo: Desde o início do tratamento do teste até o final do mês 12, até 12 meses.
Desde o início do tratamento do teste até o final do mês 12, até 12 meses.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.

DoR is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response as assessed by central independent review.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control (DC)
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.

DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST version 1.1 as assessed central independent review, from first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Progression-free survival (PFS)
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.

PFS is defined as the time from first treatment administration until tumor progression according to RECIST version 1.1 as assessed by central independent review, or death from any cause, whichever occurs earlier.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response according to response assessment in RANO-BM criteria as assessed by central independent review for patients with central nervous system (CNS) lesions at baseline
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control according to RANO-BM criteria as assessed by central independent review for patients with CNS lesions at baseline
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Duration of objective response according to RECIST 1.1 by investigator assessment
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RECIST 1.1 as assessed by the investigator
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Progression-free survival according to RECIST 1.1 as assessed by the investigator
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Objective response according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DoR in CNS lesions according to RECIST 1.1 by central independent review
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DC in CNS lesions according to RECIST 1.1 by central independent review
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: PFS in CNS lesions according to RECIST 1.1 as assessed by central independent review
Prazo: From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de julho de 2021

Conclusão Primária (Estimado)

29 de fevereiro de 2028

Conclusão do estudo (Estimado)

29 de agosto de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2021

Primeira postagem (Real)

14 de maio de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1479-0001
  • 2020-004563-47 (Número EudraCT)
  • 2024-511246-39-00 (Identificador de registro: CTIS (EU))
  • U1111-1312-5969 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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