Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
Sponsor: Boehringer Ingelheim
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Phase Ia: Maximum Tolerated Dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 21 days).
Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Time frame: At the end of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2 and 5 : Objective response (OR) as assessed by central independent review
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3, 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
Time frame: From the start of the trial treatment until end of month 12, up to 12 months.
Secondary Endpoints
Phase Ia: Number of patients experiencing DLTs during the entire treatment period
Phase Ia: Maximum measured concentration of zongertinib in plasma (Cmax)
Phase Ia: Area under the concentration-time curve of zongertinib in plasma (AUC0-t2)
Eligibility Criteria
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…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →