{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":[["brigatinib"]],"indication":"ALK-positive advanced non-small cell lung cancer","name":"J-ALTA","nct_id":"NCT03410108","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=j-alta-nct03410108. 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":"Brigatinib 90 milligram (mg), tablets, orally, once daily (QD) for first 7 days followed by brigatinib, 180 mg, tablets, orally, QD in Cycle 1 of 28 days followed by brigatinib 180 mg, tablets, orally, QD in Cycle 2 and onward cycles of 28 days until investigator-assessed progressive disease (PD) or intolerable toxicity, withdrawal of consent, or discontinuation for any other reason, whichever comes first up to Cycle 34 of 28-day cycle, until data cut-off date 29 September 2020.","label":"Brigatinib 90 mg + Brigatinib 180 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2021-07-28","type":"ACTUAL"},"conditions":["ALK-positive Advanced NSCLC"],"enrollment":{"count":104,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Brigatinib","otherNames":[],"type":"DRUG"}],"last_update":"2024-05-08","lead_sponsor":"Takeda","official_title":"A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2020-09-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Confirmed Objective Response Rate (ORR) in the Main Cohort of the Refractory Expansion Part","timeFrame":"From the start of study treatment up to confirmed CR or PR (Up to approximately 23 months)"},{"measure":"12 Months Progression-Free Survival (PFS) Rate in the Tyrosine Kinase Inhibitor (TKI) Naïve Expansion Cohort","timeFrame":"From the start of study treatment up to Month 12"}],"references":[{"citation":"Mok T, Nishio M, Yoshida T, Ahn MJ, Kudou K, Asato T, Yang H, Tong X, Vincent S, Zhang P, Yamamoto N, Kim ES. Efficacy and safety of brigatinib after alectinib in patients with ALK-positive NSCLC: Integrated analysis of the ALTA-2 and J-ALTA studies. Lung Cancer. 2025 Nov;209:108793. doi: 10.1016/j.lungcan.2025.108793. Epub 2025 Oct 9.","pmid":"41110382","type":"DERIVED"},{"citation":"Sugawara S, Kondo M, Yokoyama T, Kumagai T, Nishio M, Goto K, Nakagawa K, Seto T, Yamamoto N, Kudou K, Asato T, Zhang P, Ohe Y. Brigatinib in Japanese patients with tyrosine kinase inhibitor-naive ALK-positive non-small cell lung cancer: first results from the phase 2 J-ALTA study. Int J Clin Oncol. 2022 Dec;27(12):1828-1838. doi: 10.1007/s10147-022-02232-7. Epub 2022 Aug 29.","pmid":"36036294","type":"DERIVED"}],"start_date":{"date":"2018-01-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)","url":"https://clinicaltrials.gov/study/NCT03410108"},"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/j-alta-nct03410108"}