{"preliminary_commentary":{"by_channel":{"x_thread":5,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["poziotinib"]],"indication":null,"name":"ZENITH20","nct_id":"NCT03318939","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=zenith20-nct03318939. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.","label":"Cohort 1: Poziotinib 16 mg","type":"EXPERIMENTAL"},{"description":"Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.","label":"Cohort 2: Poziotinib 16 mg","type":"EXPERIMENTAL"},{"description":"Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.","label":"Cohort 3: Poziotinib 16 mg","type":"EXPERIMENTAL"},{"description":"Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.","label":"Cohort 4: Poziotinib 8 mg","type":"EXPERIMENTAL"},{"description":"Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease 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8mg","type":"EXPERIMENTAL"},{"description":"Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.","label":"Cohort 5: Poziotinib 10 mg","type":"EXPERIMENTAL"},{"description":"Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.","label":"Cohort 5: Poziotinib 12 mg","type":"EXPERIMENTAL"},{"description":"Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.","label":"Cohort 5: Poziotinib 16 mg","type":"EXPERIMENTAL"},{"description":"Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.","label":"Cohort 6: Poziotinib 8 mg","type":"EXPERIMENTAL"},{"description":"Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.","label":"Cohort 6: Poziotinib 16 mg","type":"EXPERIMENTAL"},{"description":"Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.","label":"Cohort 7: Poziotinib 8 mg","type":"EXPERIMENTAL"},{"description":"Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.","label":"Cohort 7: Poziotinib 16 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-04-03","type":"ACTUAL"},"conditions":["NSCLC"],"enrollment":{"count":648,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Poziotinib","otherNames":[],"type":"DRUG"}],"last_update":"2026-06-12","lead_sponsor":"Spectrum Pharmaceuticals, Inc","official_title":"A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2023-04-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Objective Response Rate (ORR)","timeFrame":"Up to 3 years"}],"references":[{"citation":"Le X, Cornelissen R, Garassino M, Clarke JM, Tchekmedyian N, Goldman JW, Leu SY, Bhat G, Lebel F, Heymach JV, Socinski MA. Poziotinib in Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Insertion Mutations After Prior Therapies: ZENITH20-2 Trial. J Clin Oncol. 2022 Mar 1;40(7):710-718. doi: 10.1200/JCO.21.01323. Epub 2021 Nov 29.","pmid":"34843401","type":"DERIVED"}],"start_date":{"date":"2017-10-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation","url":"https://clinicaltrials.gov/study/NCT03318939"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/zenith20-nct03318939"}