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En undersøgelse for at teste forskellige doser af BI 1810631 hos mennesker med forskellige typer avanceret kræft (faste tumorer med ændringer i HER2-genet)

27. oktober 2026 opdateret af: Boehringer Ingelheim

Et åbent etiket, fase I dosiseskaleringsforsøg, med dosisbekræftelse og udvidelse, af BI 1810631 som monoterapi hos patienter med avancerede eller metastatiske solide tumorer med HER2-aberrationer

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

554

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Additional US locations available on demand. Please contact for options.
  • Telefonnummer: 1-800-243-0127

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fase Ib - Dosisudvidelsesdel: Kohorte 1
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Fase Ib - Dosisudvidelsesdel: Kohorte 2
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Fase Ib - Dosisudvidelsesdel: Kohorte 3
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Fase Ib - Dosisudvidelsesdel: Kohorte 4
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Fase Ib - Dosisudvidelsesdel: Kohorte 5
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase Ia - Dose escalation part

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

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase Ib - Dose expansion part: Cohort 6

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

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase Ib - Dose expansion part: Cohort 7

Cohort only in Japan
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase Ib - Dose expansion part: Cohort 8

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

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®
Eksperimentel: Phase Ib - Dose expansion part: Cohort 9

Cohort only in China
Medicin: zongertinib

zongertinib

Andre navne:
  • BI 1810631, Hernexeos®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fase Ia: Antal patienter med dosisbegrænsende toksiciteter (DLT'er) i MTD-evalueringsperioden
Tidsramme: I slutningen af ​​cyklus 1 (hver cyklus er 21 dage).
I slutningen af ​​cyklus 1 (hver cyklus er 21 dage).
Fase Ib: Kohorte 4: Objektiv respons ifølge Respons Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Phase Ia: Maximum Tolerated Dose (MTD)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fase Ia: Antal patienter, der oplever DLT i hele behandlingsperioden
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 8, op til 8 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 8, op til 8 måneder.
Fase Ib - Kohorte 4: Varighed af objektiv respons (DoR) ifølge RANO-BM ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Kohorte 4: Sygdomskontrol (DC) ifølge RANO-BM ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Kohorte 4: Progressionsfri overlevelse (PFS) ifølge RANO-BM vurderet ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Kohorte 4: ELLER ifølge RECIST 1.1 ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Kohorte 4: Varighed af OR i henhold til RECIST 1.1 ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Kohorte 4: DC ifølge RECIST 1.1 ved central uafhængig gennemgang
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Alle kohorter: Antal patienter, der oplever DLT i hele behandlingsperioden
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase Ib - Alle kohorter: Ændring fra baseline til dag 1 i cyklus 5 i EORTC Core Quality of Life-spørgeskema (EORTC QLQ-C30) fysisk fungerende domæne-score
Tidsramme: Baseline og på dag 1 af cyklus 5 (hver cyklus er 21 dage).
Baseline og på dag 1 af cyklus 5 (hver cyklus er 21 dage).
Fase Ib - Alle kohorter: Ændring fra baseline til dag 1 i cyklus 5 i ikke-småcellet lungekræft Symptom Assessment Questionnaire (NSCLC-SAQ) total score
Tidsramme: Baseline og på dag 1 af cyklus 5 (hver cyklus er 21 dage).
Baseline og på dag 1 af cyklus 5 (hver cyklus er 21 dage).
Fase Ib - Alle kohorter: Ændring fra baseline til dag 1 i cyklus 5 i EORTC-punktliste 46 (IL46) score
Tidsramme: Baseline og på dag 1 af cyklus 5 (hver cyklus er 21 dage).
Baseline og på dag 1 af cyklus 5 (hver cyklus er 21 dage).
Fase Ia: Maksimal målt koncentration af zongertinib i plasma (Cmax)
Tidsramme: På dag 1 og på dag 15 i cyklus 1 (hver cyklus er 21 dage).
På dag 1 og på dag 15 i cyklus 1 (hver cyklus er 21 dage).
Fase Ia: Areal under koncentration-tid-kurven for zongertinib i plasma (AUC0-t2)
Tidsramme: På dag 1 og på dag 15 i cyklus 1 (hver cyklus er 21 dage).
På dag 1 og på dag 15 i cyklus 1 (hver cyklus er 21 dage).
Fase Ib - Alle kohorter: Samlet overlevelse (OS), defineret som tid fra første behandlingsadministrering til død af enhver årsag
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fase IB - Kohort 4: PFS I henhold til RECIST 1.1 af Central Independent Review
Tidsramme: Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Fra starten af ​​forsøgsbehandlingen til slutningen af ​​måned 12, op til 12 måneder.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. juli 2021

Primær færdiggørelse (Anslået)

29. februar 2028

Studieafslutning (Anslået)

29. august 2029

Datoer for studieregistrering

Først indsendt

4. maj 2021

Først indsendt, der opfyldte QC-kriterier

12. maj 2021

Først opslået (Faktiske)

14. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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