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En studie for å teste forskjellige doser av BI 1810631 hos personer med forskjellige typer avansert kreft (faste svulster med endringer i HER2-genet)

27. oktober 2026 oppdatert av: Boehringer Ingelheim

En åpen etikett, fase I doseeskaleringsforsøk, med dosebekreftelse og utvidelse, av BI 1810631 som monoterapi hos pasienter med avanserte eller metastatiske solide svulster med HER2-aberrasjoner

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

554

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

Studiesteder

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
        • Fullført
        • Macquarie University
  • Belgia
      • Anderlecht/Brussels-Capital, Belgia, 1070
        • Aktiv, ikke rekrutterende
        • Brussels - HOSP Jules Bordet
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Rekruttering
        • University of Alabama at Birmingham
        • Ta kontakt med:
    • California
      • Beverly Hills, California, Forente stater, 90212
        • Fullført
        • Precision NextGen Oncology
      • Duarte, California, Forente stater, 91010
      • Huntington Beach, California, Forente stater, 92648
        • Fullført
        • City of Hope - Seacliff
      • Irvine, California, Forente stater, 92618
        • Fullført
        • City of Hope-Irvine-69674
      • Los Angeles, California, Forente stater, 90067
      • Orange, California, Forente stater, 92868
      • Sacramento, California, Forente stater, 95817
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20007
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Rekruttering
        • Holy Cross Hospital-Fort Lauderdale-57892
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
    • New York
      • New York, New York, Forente stater, 10016
        • Rekruttering
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • Ta kontakt med:
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • Sarah Cannon Research Institute-Nashville-48456
        • Ta kontakt med:
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Rekruttering
        • Mary Crowley Cancer Research Center
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • The University of Texas MD Anderson Cancer Center
        • Ta kontakt med:
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • Fred Hutchinson Cancer Research Center
        • Ta kontakt med:
  • Frankrike
      • Bron, Frankrike, 69677
        • Aktiv, ikke rekrutterende
        • Hopital Louis Pradel
      • Lyon, Frankrike, 69373
        • Aktiv, ikke rekrutterende
        • CTR Leon Berard
      • Marseille, Frankrike, 13385
        • Aktiv, ikke rekrutterende
        • HOP Timone
      • Paris, Frankrike, 75005
        • Aktiv, ikke rekrutterende
        • INS Curie
      • Rennes, Frankrike, 35000
        • Aktiv, ikke rekrutterende
        • HOP Pontchaillou
      • Villejuif, Frankrike, 94805
        • Aktiv, ikke rekrutterende
        • Institut Gustave Roussy
  • 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
        • Fullført
        • 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
        • Fullført
        • The Chaim Sheba Medical Center Tel HaShomer
  • Italia
      • Candiolo (TO), Italia, 10060
        • Fullført
        • Istituto Di Candiolo
      • Naples, Italia, 80131
        • Fullført
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
      • Parma, Italia, 43100
        • Fullført
        • Azienda Ospedaliera Unversitaria di Parma
  • Japan
      • Chiba, Kashiwa, Japan, 277-8577
        • Rekruttering
        • National Cancer Center Hospital East
        • Ta kontakt med:
      • Ehime, Matsuyama, Japan, 791-0280
        • Rekruttering
        • Shikoku Cancer Center
        • Ta kontakt med:
      • Hiroshima, Hiroshima, Japan, 734-8551
        • Rekruttering
        • Hiroshima University Hospital
        • Ta kontakt med:
      • Osaka, Osaka, Japan, 541-8567
        • Rekruttering
        • Osaka International Cancer Institute
        • Ta kontakt med:
      • Osaka, Sakai, Japan, 590-0197
        • Rekruttering
        • Kindai University Hospital
        • Ta kontakt med:
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Rekruttering
        • Hamamatsu University Hospital
        • Ta kontakt med:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
        • Ta kontakt med:
  • Kina
      • Beijing, Kina, 100036
        • Fullført
        • Beijing Cancer Hospital
      • Changchun, Kina, 130021
        • Aktiv, ikke rekrutterende
        • The First Hospital of Jilin University
      • Changchun, Kina, 130012
        • Fullført
        • 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
        • Fullført
        • The Affiliated Cancer Hospital, Guangxi Medical University
      • Shanghai, Kina, 200030
        • Fullført
        • 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
        • Fullført
        • 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
  • Nederland
      • Amsterdam, Nederland, 1066 CX
        • Rekruttering
        • Nederlands Kanker Instituut
        • Ta kontakt med:
      • Leiden, Nederland, 2333 ZA
        • Aktiv, ikke rekrutterende
        • Leids Universitair Medisch Centrum (LUMC)
  • Portugal
      • Porto, Portugal, 4100-180
        • Fullført
        • Hospital CUF Porto
  • Singapore
      • Singapore, Singapore, 169610
        • Rekruttering
        • National Cancer Centre Singapore
        • Ta kontakt med:
      • Singapore, Singapore, 119228
        • Fullført
        • National University Hospital-Singapore-22806
  • Spania
      • Barcelona, Spania, 08035
        • Aktiv, ikke rekrutterende
        • Hospital Universitari Vall d'Hebron
      • L'Hospitalet de Llobregat, Spania, 08907
        • Aktiv, ikke rekrutterende
        • Hospital Duran i Reynals
      • Madrid, Spania, 28041
        • Aktiv, ikke rekrutterende
        • Hospital Universitario 12 de Octubre
      • Madrid, Spania, 28007
        • Fullført
        • Hospital General Universitario Gregorio Marañón
      • Málaga, Spania, 29010
        • Aktiv, ikke rekrutterende
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spania, 46010
        • Aktiv, ikke rekrutterende
        • Hospital Clinico Universitario de Valencia
  • Storbritannia
      • London, Storbritannia, SW3 6JJ
        • Aktiv, ikke rekrutterende
        • The Royal Marsden Hospital, Chelsea
      • London, Storbritannia, W12 0HS
        • Aktiv, ikke rekrutterende
        • Hammersmith Hospital
      • Sutton, Storbritannia, SM2 5PT
        • Aktiv, ikke rekrutterende
        • The Royal Marsden Hospital, Sutton
  • Sverige
      • Stockholm, Sverige, 171 76
        • Fullført
        • Karolinska Universitetssjukhuset Solna
  • Sør -Korea
      • Chungju, Sør -Korea, 28644
        • Rekruttering
        • Chungbuk National University Hospital
        • Ta kontakt med:
      • Seongnam, Sør -Korea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 06351
        • Rekruttering
        • Samsung Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 03722
        • Aktiv, ikke rekrutterende
        • Severance Hospital
  • Tyskland
      • Augsburg, Tyskland, 86156
        • Fullført
        • Universitätsklinikum Augsburg
      • Cologne, Tyskland, 50937
        • Rekruttering
        • Universitätsklinikum Köln (AöR)
        • Ta kontakt med:
      • Dresden, Tyskland, 01307
      • Giessen, Tyskland, 35392
        • Rekruttering
        • Justus-Liebig Universität Gießen
        • Ta kontakt med:
      • Oldenburg, Tyskland, 26121
  • Østerrike
      • Linz, Østerrike, 4020
        • Fullført
        • Ordensklinikum Linz GmbH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fase Ib - Doseutvidelsesdel: Kohort 1
Legemiddel: zongertinib

zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Eksperimentell: Fase Ib - Doseutvidelsesdel: Kohort 2
Legemiddel: zongertinib

zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Eksperimentell: Fase Ib - Doseutvidelsesdel: Kohort 3
Legemiddel: zongertinib

zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Eksperimentell: Fase Ib - Doseutvidelsesdel: Kohort 4
Legemiddel: zongertinib

zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Eksperimentell: Fase Ib - Doseutvidelsesdel: Kohort 5
Legemiddel: zongertinib

zongertinib

Andre navn:
  • BI 1810631, Hernexeos®
Eksperimentell: Phase Ia - Dose escalation part

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

zongertinib

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

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

zongertinib

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

Cohort only in Japan
Legemiddel: zongertinib

zongertinib

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

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

zongertinib

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

Cohort only in China
Legemiddel: zongertinib

zongertinib

Andre navn:
  • BI 1810631, Hernexeos®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fase Ia: Antall pasienter med dosebegrensende toksisiteter (DLT) i MTD-evalueringsperioden
Tidsramme: På slutten av syklus 1 (hver syklus er 21 dager).
På slutten av syklus 1 (hver syklus er 21 dager).
Fase Ib: Kohort 4: Objektiv respons i henhold til Respons Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) ved sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 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
Tiltaksbeskrivelse
Tidsramme
Fase Ia: Antall pasienter som opplever DLT i hele behandlingsperioden
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 8, opptil 8 måneder.
Fra starten av prøvebehandlingen til slutten av måned 8, opptil 8 måneder.
Fase Ib - Kohort 4: Varighet av objektiv respons (DoR) i henhold til RANO-BM ved sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Kohort 4: Sykdomskontroll (DC) i henhold til RANO-BM av sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Kohort 4: Progresjonsfri overlevelse (PFS) i henhold til RANO-BM vurdert av sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Kohort 4: ELLER i henhold til RECIST 1.1 ved sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Kohort 4: Varighet av OR i henhold til RECIST 1.1 ved sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Kohort 4: DC i henhold til RECIST 1.1 ved sentral uavhengig gjennomgang
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Alle kohorter: Antall pasienter som opplever DLT i løpet av hele behandlingsperioden
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase Ib - Alle kohorter: Endring fra baseline til dag 1 av syklus 5 i EORTC Core Quality of Life-spørreskjema (EORTC QLQ-C30) fysisk fungerende domenepoengsum
Tidsramme: Grunnlinje og på dag 1 av syklus 5 (hver syklus er 21 dager).
Grunnlinje og på dag 1 av syklus 5 (hver syklus er 21 dager).
Fase Ib - Alle kohorter: Endring fra baseline til dag 1 av syklus 5 i total poengsum for ikke-småcellet lungekreft Symptom Assessment Questionnaire (NSCLC-SAQ)
Tidsramme: Grunnlinje og på dag 1 av syklus 5 (hver syklus er 21 dager).
Grunnlinje og på dag 1 av syklus 5 (hver syklus er 21 dager).
Fase Ib - Alle kohorter: Endring fra baseline til dag 1 av syklus 5 i EORTC-punktliste 46 (IL46) poengsum
Tidsramme: Grunnlinje og på dag 1 av syklus 5 (hver syklus er 21 dager).
Grunnlinje og på dag 1 av syklus 5 (hver syklus er 21 dager).
Fase Ia: Maksimal målt konsentrasjon av zongertinib i plasma (Cmax)
Tidsramme: På dag 1 og på dag 15 av syklus 1 (hver syklus er 21 dager).
På dag 1 og på dag 15 av syklus 1 (hver syklus er 21 dager).
Fase Ia: Areal under konsentrasjon-tid-kurven for zongertinib i plasma (AUC0-t2)
Tidsramme: På dag 1 og på dag 15 av syklus 1 (hver syklus er 21 dager).
På dag 1 og på dag 15 av syklus 1 (hver syklus er 21 dager).
Fase Ib - Alle kohorter: Total overlevelse (OS), definert som tid fra første behandlingsadministrering til død uansett årsak
Tidsramme: Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måned 12, opptil 12 måneder.
Fase IB - Kohort 4: PFS i henhold til RECIST 1.1 av Central Independent Review
Tidsramme: Fra starten av prøvebehandlingen til slutten av måneden 12, opptil 12 måneder.
Fra starten av prøvebehandlingen til slutten av måneden 12, opptil 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. juli 2021

Primær fullføring (Antatt)

29. februar 2028

Studiet fullført (Antatt)

29. august 2029

Datoer for studieregistrering

Først innsendt

4. mai 2021

Først innsendt som oppfylte QC-kriteriene

12. mai 2021

Først lagt ut (Faktiske)

14. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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