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Een onderzoek om verschillende doses BI 1810631 te testen bij mensen met verschillende soorten gevorderde kanker (vaste tumoren met veranderingen in het HER2-gen)

27 oktober 2026 bijgewerkt door: Boehringer Ingelheim

Een open-label, fase I-dosisescalatieonderzoek, met dosisbevestiging en -uitbreiding, van BI 1810631 als monotherapie bij patiënten met gevorderde of gemetastaseerde vaste tumoren met HER2-afwijkingen

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

554

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Fase Ib - Deel dosisuitbreiding: Cohort 1
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Fase Ib - Deel dosisuitbreiding: Cohort 2
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Fase Ib - Deel dosisuitbreiding: Cohort 3
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Fase Ib - Deel dosisuitbreiding: Cohort 4
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Fase Ib - Deel dosisuitbreiding: Cohort 5
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Phase Ia - Dose escalation part

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

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Phase Ib - Dose expansion part: Cohort 6

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

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Phase Ib - Dose expansion part: Cohort 7

Cohort only in Japan
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Phase Ib - Dose expansion part: Cohort 8

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

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®
Experimenteel: Phase Ib - Dose expansion part: Cohort 9

Cohort only in China
Geneesmiddel: zongertinib

zongertinib

Andere namen:
  • BI 1810631, Hernexeos®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fase Ia: aantal patiënten met dosisbeperkende toxiciteiten (DLT's) in de MTD-evaluatieperiode
Tijdsspanne: Aan het einde van cyclus 1 (elke cyclus duurt 21 dagen).
Aan het einde van cyclus 1 (elke cyclus duurt 21 dagen).
Fase Ib: Cohort 4: Objectieve respons volgens Response Assessment in Neuro-Oncology for Brain Metastasen (RANO-BM) door centrale onafhankelijke review
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Phase Ia: Maximum Tolerated Dose (MTD)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fase Ia: aantal patiënten met DLT's gedurende de gehele behandelingsperiode
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 8, tot 8 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 8, tot 8 maanden.
Fase Ib - Cohort 4: Duur van objectieve respons (DoR) volgens RANO-BM door centrale onafhankelijke beoordeling
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Cohort 4: Ziektebestrijding (DC) volgens RANO-BM door centrale onafhankelijke beoordeling
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Cohort 4: Progressievrije overleving (PFS) volgens RANO-BM zoals beoordeeld door centrale onafhankelijke beoordeling
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Cohort 4: OF volgens RECIST 1.1 door centrale onafhankelijke beoordeling
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Cohort 4: Duur van de OK volgens RECIST 1.1 door centrale onafhankelijke beoordeling
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Cohort 4: DC volgens RECIST 1.1 door centrale onafhankelijke beoordeling
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Alle cohorten: aantal patiënten dat DLT's ondervond tijdens de gehele behandelingsperiode
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, tot 12 maanden.
Fase Ib - Alle cohorten: verandering vanaf baseline tot dag 1 van cyclus 5 in EORTC Core Quality of Life-vragenlijst (EORTC QLQ-C30) domeinscore fysiek functioneren
Tijdsspanne: Basislijn en op dag 1 van cyclus 5 (elke cyclus duurt 21 dagen).
Basislijn en op dag 1 van cyclus 5 (elke cyclus duurt 21 dagen).
Fase Ib - Alle cohorten: verandering vanaf baseline tot dag 1 van cyclus 5 in totaalscore voor niet-kleincellige longkanker Symptom Assessment Questionnaire (NSCLC-SAQ)
Tijdsspanne: Basislijn en op dag 1 van cyclus 5 (elke cyclus duurt 21 dagen).
Basislijn en op dag 1 van cyclus 5 (elke cyclus duurt 21 dagen).
Fase Ib - Alle cohorten: verandering vanaf baseline tot dag 1 van cyclus 5 in EORTC-itemlijst 46 (IL46)-score
Tijdsspanne: Basislijn en op dag 1 van cyclus 5 (elke cyclus duurt 21 dagen).
Basislijn en op dag 1 van cyclus 5 (elke cyclus duurt 21 dagen).
Fase Ia: Maximaal gemeten concentratie zongertinib in plasma (Cmax)
Tijdsspanne: Op dag 1 en op dag 15 van cyclus 1 (elke cyclus duurt 21 dagen).
Op dag 1 en op dag 15 van cyclus 1 (elke cyclus duurt 21 dagen).
Fase Ia: Gebied onder de concentratie-tijdcurve van zongertinib in plasma (AUC0-t2)
Tijdsspanne: Op dag 1 en op dag 15 van cyclus 1 (elke cyclus duurt 21 dagen).
Op dag 1 en op dag 15 van cyclus 1 (elke cyclus duurt 21 dagen).
Fase Ib - Alle cohorten: Totale overleving (OS), gedefinieerd als de tijd vanaf de eerste behandeling tot overlijden door welke oorzaak dan ook
Tijdsspanne: Vanaf het begin van de proefbehandeling tot eind maand 12, maximaal 12 maanden.
Vanaf het begin van de proefbehandeling tot eind maand 12, maximaal 12 maanden.
Fase IB - Cohort 4: PFS volgens RECIST 1.1 door Central Independent Review
Tijdsspanne: Vanaf het begin van de proefbehandeling tot het einde van de maand 12, tot 12 maanden.
Vanaf het begin van de proefbehandeling tot het einde van de maand 12, tot 12 maanden.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boehringer Ingelheim

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 juli 2021

Primaire voltooiing (Geschat)

29 februari 2028

Studie voltooiing (Geschat)

29 augustus 2029

Studieregistratiedata

Eerst ingediend

4 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2021

Eerst geplaatst (Werkelijk)

14 mei 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

27 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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