Solid Tumours
Conditions
Interventions
Oral dose of zongertinib each day until criteria for stopping medication are met.
Sponsors
Hagimori Kenta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion criteria: Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Patients >=18 years old or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the Informed consent form (ICF). Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of HER2 overexpression/amplification Known activating HER2 mutations An archival (enrolment) tumour tissue sample must be submitted after inclusion of the patient to retrospectively confirm the HER2 status (enrolment tissue sample). If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor. Please note that sample must not be from an area irradiated prior to the biopsy. 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. Further inclusion criteria apply.
Exclusion criteria
Exclusion criteria: Main Exclusion criteria: Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC) Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 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 Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial Not completely recovered from major surgery (major according to the investigator's assessment) performed prior to screening or planned within 6 months after screening, e.g. hip replacement Further exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response (OR) is defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1, as assessed by central independent review, from the date of treatment start until the earliest date of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or trial treatment discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of objective response (DOR) is defined as the time from first documented confirmed OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response, assessed by central independent review. - Progression-free survival (PFS) is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first. - Disease control (DC) is defined as best overall response of CR or PR or stable disease (SD) where best overall response is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review. - Occurrence of treatment-emergent AEs. - Change from baseline to Week 48 or PD, if earlier, in the European Organisation for Research and Treatment of Cancer item list (EORTC IL19) (5 items, physical functioning scale of EORTC quality of life questionnaire (QLQ-C30). - Overall survival (OS) is defined as the time from start of treatment to death from any cause. | — |
Countries
Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Netherlands, Norway, South Korea, Spain, USA
Contacts
Public ContactTomohiro Yamagami
Boehringer Ingelheim
Outcome results
None listed