Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2023
Poziotinib in Treatment-Naive NSCLC Harboring HER2 Exon 20 Mutations: ZENITH20-4, A Multicenter, Multicohort, Open-Label, Phase 2 Trial (Cohort 4).
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Poziotinib in non-small-cell lung cancer patients with HER2 exon 20 mutations: A pooled analysis of randomized clinical trials.Medicine · 2022Pooled it
- New Treatment Strategies for Rare Genomic Alterations:Cancers · 2026Review
- Loss of Payload Sensitivity and Other Mechanisms of Resistance to T-DXd in HER2-Mutant NSCLC: Implications for Subsequent Responsiveness to HER2 TKIs.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026Article
- Intestinal Organoid-Based Mathematical Modeling Predicts Clinical Gastrointestinal Toxicity of Oral Oncology Drugs.CPT: pharmacometrics & systems pharmacology · 2026Article
- Evaluating zongertinib in the treatment of patients with HER2-mutant non-small cell lung cancer.Future oncology (London, England) · 2026Review
- AXL-SHC1 signaling axis mediates adaptive resistance to HER2-targeted tyrosine kinase inhibitors in HER2-aberrant lung and gastric cancers.NPJ precision oncology · 2026Article
- Evolving treatment strategies for HER2-altered non-small-cell lung cancer: the rise of TKIs and ADCs.Frontiers in oncology · 2026Review
- A Review on EGFR-Tyrosine Kinase Inhibitors and their Resistance Mechanisms.Current pharmaceutical design · 2026Review
- Real-world outcomes of trastuzumab deruxtecan as second- or further-line treatment in patients withTranslational lung cancer research · 2025Article
- Recent Advances in the Development and Clinical Use of HER2 Inhibitors in Non-Small Cell Lung Cancer.Biomolecules · 2025Review
- Enhanced HER2 internalization by clathrin-dependent endocytosis in non-small cell lung cancer positive for HER2 mutations.British journal of cancer · 2025Article
- [Advances in Targeted Therapy for Advanced Non-small Cell Lung Cancer with HER2 Mutation].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025Review
- HER2 in Non-Small Cell Lung Cancer (NSCLC): Evolution of the Therapeutic Landscape and Emerging Drugs-A Long Way to the Top.Molecules (Basel, Switzerland) · 2025Review
- Research advancements of antibody drug conjugates in non-small cell lung cancer with HER2 alterations.Journal of translational medicine · 2025Review
- Genomic and clinical characterization of HER2 exon 20 mutations in non-small cell lung cancer: insights from a multicenter study in South China.BMC cancer · 2025Observational
- HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Article
- Recent advances in therapeutic strategies for non-small cell lung cancer.Journal of hematology & oncology · 2025Review
- New advances in the treatment of EGFR exon20ins mutant advanced NSCLC.American journal of cancer research · 2025Review
- HER2 alterations in non-small cell lung cancer (NSCLC): from biology and testing to advances in treatment modalities.Frontiers in oncology · 2025Review
- The continually evolving landscape of novel therapies in oncogene-driven advanced non-small-cell lung cancer.Therapeutic advances in medical oncology · 2025Review
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Authors and funding
17 authors.
Funding
Abstract
introductionERBB2 or HER2 alterations are found in approximately 2% to 5% of NSCLCs; most are exon 20 insertion mutations. The efficacy and safety of poziotinib, an oral tyrosine kinase inhibitor, were assessed in patients with treatment-naive NSCLC whose tumors harbor HER2 exon 20 insertions.
methodsZENITH20 is an open-label, multicohort, multicenter, global, phase 2 trial. ZENITH20-C4 enrolled treatment-naive patients with NSCLC with tumors harboring HER2 exon 20 insertions. Poziotinib was administered 16 mg once daily (QD) or 8 mg twice daily (BID). The primary end point was objective response rate (ORR) by independent central review. Secondary and exploratory end points included disease control rate, duration of response, progression-free survival, and safety.
resultsA total of 80 patients (16 mg QD, n = 47; 8 mg BID, n = 33) were treated in ZENITH20-C4. ORR was 39% (95% confidence interval [CI]: 28%-50%; 31 of 80), with a disease control rate of 73% (95% CI: 61%-82%; 58 of 80); 80% of the patients experienced tumor reduction. Median duration of response was 5.7 (95% CI: 4.6-11.9) months, and median progression-free survival was 5.6 (95% CI: 5.4-7.3) months. The most common grade 3 treatment-related adverse events were rash (QD, 45%; BID, 39%), stomatitis (QD, 21%; BID, 15%), and diarrhea (QD, 15%; BID, 21%). Among all subtypes of HER2 exon 20 insertions, seven patients (9%) harboring tumors with G778_P780dupGSP had the best clinical outcomes (ORR, 71%).
conclusionsPoziotinib was found to have clinically meaningful efficacy with a manageable toxicity profile for patients with treatment-naive NSCLC harboring HER2 exon 20 mutations.
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