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Zongertinib / Lung Cancer, Non Squamous, Non Small Cell / Cisplatin · Phase 2 Trial
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial registration evaluating tolerability of zongertinib combined with platinum-based chemotherapy with or without pembrolizumab in treatment-naïve adults with HER2-mutant advanced non-squamous NSCLC. No results are posted in this registry record; the study is actively recruiting and will not inform clinical decisions until completion and publication of results.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Lung Cancer, Non-squamous, Non-small Cell; age from 18 Years. Intervention: Arm A: zongertinib + cisplatin or carboplatin and pemetrexed; Arm B: zongertinib + cisplatin or carboplatin and pemetrexe…. Compared with: Zongertinib plus platinum-based chemotherapy (without pembrolizumab) versus zongertinib plus platinum-based chemotherapy plus pembrolizumab.. n = 60. 17 sites across 7 countries.
This is a planned Phase 2 trial registration evaluating tolerability of zongertinib combined with platinum-based chemotherapy with or without pembrolizumab in treatment-naïve adults with HER2-mutant advanced non-squamous NSCLC. No results are posted in this registry record; the study is actively recruiting and will not inform clinical decisions until completion and publication of results.
Primary outcome is tolerability (discontinuation/interruption), not efficacy or survival.
This trial is still recruiting and has not reported results. Clinicians should not base treatment decisions on this registration. Results, once published, may inform the tolerability profile of this combination strategy in a molecularly selected population.
This is an ongoing Phase 2 trial registration with no results reported; it describes a planned study of tolerability in a molecularly defined but small population, which cannot yet inform clinical practice.
As stated by the source record.
Quoted from the source exactly as published.
This trial is still recruiting and has not reported results. Clinicians should not base treatment decisions on this registration. Results, once published, may inform the tolerability profile of this combination strategy in a molecularly selected population.
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 (NCT07486817). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Lung Cancer, Non-squamous, Non-small Cell. Interventions: DRUG: Zongertinib; DRUG: Cisplatin; DRUG: Carboplatin; DRUG: Pemetrexed; DRUG: Pembrolizumab. Primary outcome measures: Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment , up to 6 weeks. Brief summary: This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth. Participants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years. Pembrolizumab is given every 3 weeks for up to 2 years. This study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.