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Neoplasm Metastasis / Non Small Cell Lung Cancer · Phase 1 Trial
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for zongertinib, a novel HER2-targeting agent, in adults with HER2-mutant solid tumours and non-small-cell lung cancer. The study is designed to establish maximum tolerated dose and preliminary efficacy; no results are currently posted in this registry record.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Neoplasm Metastasis, Non-Small Cell Lung Cancer; age from 18 Years. Intervention: Phase Ia - Dose escalation part; Phase Ib - Dose expansion part: Cohort 1; Phase Ib - Dose expansion part: Cohort 2; Phase Ib - Dose expansion part: Cohort 3; Phase Ib - Dose expansion part: Cohort 4; Phase Ib - Dose expansion part: Cohort…. n = 554. 85 sites across 18 countries.
This is a Phase 1 trial registration for zongertinib, a novel HER2-targeting agent, in adults with HER2-mutant solid tumours and non-small-cell lung cancer. The study is designed to establish maximum tolerated dose and preliminary efficacy; no results are currently posted in this registry record.
This is a Phase 1 trial; efficacy is assessed as secondary to safety and tolerability. Long-term efficacy and safety data are not reported.
Clinicians should await posted results before considering zongertinib for use. This registration documents a first-in-human trial with safety and preliminary efficacy endpoints; efficacy claims cannot be made until Phase Ib data mature.
This is a Phase 1 trial registration with no results posted; the study is active but not yet recruiting and designed to establish safety and tolerability before efficacy assessment.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should await posted results before considering zongertinib for use. This registration documents a first-in-human trial with safety and preliminary efficacy endpoints; efficacy claims cannot be made until Phase Ib data mature.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04886804). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 554 participants (ESTIMATED). Conditions: Neoplasm Metastasis, Non-Small Cell Lung Cancer. Interventions: DRUG: zongertinib. Primary outcome measures: Phase Ia: Maximum Tolerated Dose (MTD) , 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 , 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 , 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 , From the start of the trial treatment until end of month 12, up to 12 months.; Phase Ib: Cohort 4: Objective response according to Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) by central independent review , From the start of the trial treatment until end of month 12, up to 12 months.. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.