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En studie för att testa olika doser av BI 1810631 hos personer med olika typer av avancerad cancer (fasta tumörer med förändringar i HER2-genen)

27 oktober 2026 uppdaterad av: Boehringer Ingelheim

En öppen etikett, fas I-dosupptrappningsförsök, med dosbekräftelse och utökning, av BI 1810631 som monoterapi hos patienter med avancerade eller metastaserande solida tumörer 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

554

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Fas Ib - Dosexpansionsdel: Kohort 1
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Fas Ib - Dosexpansionsdel: Kohort 2
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Fas Ib - Dosexpansionsdel: Kohort 3
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Fas Ib - Dosexpansionsdel: Kohort 4
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Fas Ib - Dosexpansionsdel: Kohort 5
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Phase Ia - Dose escalation part

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

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Phase Ib - Dose expansion part: Cohort 6

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

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Phase Ib - Dose expansion part: Cohort 7

Cohort only in Japan
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Phase Ib - Dose expansion part: Cohort 8

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

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®
Experimentell: Phase Ib - Dose expansion part: Cohort 9

Cohort only in China
Läkemedel: zongertinib

zongertinib

Andra namn:
  • BI 1810631, Hernexeos®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fas Ia: Antal patienter med Dosbegränsande Toxicitet (DLT) under MTD-utvärderingsperioden
Tidsram: I slutet av cykel 1 (varje cykel är 21 dagar).
I slutet av cykel 1 (varje cykel är 21 dagar).
Fas Ib: Kohort 4: Objektiv respons enligt Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) av central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Phase Ia: Maximum Tolerated Dose (MTD)
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fas Ia: Antal patienter som upplever DLT under hela behandlingsperioden
Tidsram: Från början av provbehandlingen till slutet av månad 8, upp till 8 månader.
Från början av provbehandlingen till slutet av månad 8, upp till 8 månader.
Fas Ib - Kohort 4: Duration of Objective Response (DoR) enligt RANO-BM av central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Kohort 4: Sjukdomskontroll (DC) enligt RANO-BM av central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Kohort 4: Progressionsfri överlevnad (PFS) enligt RANO-BM bedömd av central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Kohort 4: ELLER enligt RECIST 1.1 genom central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Kohort 4: Varaktighet av OR enligt RECIST 1.1 av central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Kohort 4: DC enligt RECIST 1.1 genom central oberoende granskning
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Alla kohorter: Antal patienter som upplever DLT under hela behandlingsperioden
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas Ib - Alla kohorter: Ändring från baslinje till dag 1 av cykel 5 i EORTC Core Quality of Life-enkät (EORTC QLQ-C30) domänpoäng för fysiskt fungerande domän
Tidsram: Baslinje och på dag 1 av cykel 5 (varje cykel är 21 dagar).
Baslinje och på dag 1 av cykel 5 (varje cykel är 21 dagar).
Fas Ib - Alla kohorter: Ändring från baslinje till dag 1 av cykel 5 i totalpoäng för icke-småcellig lungcancer Symtom Assessment Questionnaire (NSCLC-SAQ)
Tidsram: Baslinje och på dag 1 av cykel 5 (varje cykel är 21 dagar).
Baslinje och på dag 1 av cykel 5 (varje cykel är 21 dagar).
Fas Ib - Alla kohorter: Ändra från baslinje till dag 1 av cykel 5 i EORTC-objektlista 46 (IL46) poäng
Tidsram: Baslinje och på dag 1 av cykel 5 (varje cykel är 21 dagar).
Baslinje och på dag 1 av cykel 5 (varje cykel är 21 dagar).
Fas Ia: Maximal uppmätt koncentration av zongertinib i plasma (Cmax)
Tidsram: På dag 1 och dag 15 av cykel 1 (varje cykel är 21 dagar).
På dag 1 och dag 15 av cykel 1 (varje cykel är 21 dagar).
Fas Ia: Area under koncentration-tid-kurvan för zongertinib i plasma (AUC0-t2)
Tidsram: På dag 1 och dag 15 av cykel 1 (varje cykel är 21 dagar).
På dag 1 och dag 15 av cykel 1 (varje cykel är 21 dagar).
Fas Ib - Alla kohorter: Total överlevnad (OS), definierad som tiden från första behandlingsadministrering till dödsfall oavsett orsak
Tidsram: Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Från början av provbehandlingen till slutet av månad 12, upp till 12 månader.
Fas IB - Kohort 4: PFS enligt RECIST 1.1 av Central Independent Review
Tidsram: Från början av försöksbehandlingen till slutet av månaden 12, upp till 12 månader.
Från början av försöksbehandlingen till slutet av månaden 12, upp till 12 månader.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

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Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 juli 2021

Primärt slutförande (Beräknad)

29 februari 2028

Avslutad studie (Beräknad)

29 augusti 2029

Studieregistreringsdatum

Först inskickad

4 maj 2021

Först inskickad som uppfyllde QC-kriterierna

12 maj 2021

Första postat (Faktisk)

14 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

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IPD-planbeskrivning

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

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