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Advanced Non Small Cell Lung Cancer, HER2 Mutation / Sevabertinib / Cisplatin · Phase 3 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 trial registration for sevabertinib versus standard chemotherapy in HER2-mutated advanced NSCLC, with an estimated enrollment of 444 participants and primary endpoint of progression-free survival over 2 years. No results have been posted to the registry as of this record; the study is currently recruiting and no efficacy or safety data are available.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Advanced Non-small Cell Lung Cancer, HER2 Mutation; age from 18 Years. Intervention: Sevabertinib. Compared with: Standard of care (SoC) — Active Comparator. n = 444. 279 sites across 36 countries.
This is a Phase 3 trial registration for sevabertinib versus standard chemotherapy in HER2-mutated advanced NSCLC, with an estimated enrollment of 444 participants and primary endpoint of progression-free survival over 2 years. No results have been posted to the registry as of this record; the study is currently recruiting and no efficacy or safety data are available.
This is a registry record; no results have been reported and no efficacy or safety data are available
The source did not state who this applies to in practice.
Phase 3 trial registration with no results posted; describes planned enrollment and design only, supporting no current evidence of efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT06452277). This is a study registration, not published results. Lead sponsor: Bayer. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 444 participants (ESTIMATED). Conditions: Advanced Non-small Cell Lung Cancer, HER2 Mutation. Interventions: DRUG: Sevabertinib; DRUG: Pembrolizumab; DRUG: Cisplatin; DRUG: Carboplatin; DRUG: Pemetrexed. Primary outcome measures: Progression free survival (PFS) per RECIST 1.1 as assessed by BICR , Up to approximately 2 years. Brief summary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
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