{"preliminary_commentary":{"by_channel":{"x_thread":22,"youtube":6,"podcast":6},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04129502\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"EXCLAIM-2","nct_id":"NCT04129502","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=exclaim-2-nct04129502. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"TAK-788 160 milligram (mg) with or without food, capsules, orally, once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria.","label":"TAK-788 Group (Arm A)","type":"EXPERIMENTAL"},{"description":"Pemetrexed 500 milligram per meter square (mg/m\\^2) plus cisplatin 75 mg/m\\^2, infusion, IV, once on Day 1 of 21-day cycle pemetrexed 500 mg/m\\^2 plus carboplatin, infusion, IV, once at a dose calculated to produce area under curve (AUC) of 5 milligram\\*minute per milliliter (mg\\*min/mL) on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/cisplatin or pemetrexed/carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m\\^2, on Day 1 of a 21-day cycle thereafter.","label":"Platinum-based Chemotherapy Group (Arm B)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-09-22","type":"ACTUAL"},"conditions":["Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)"],"enrollment":{"count":354,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"TAK-788","otherNames":["AP32788","Mobocertinib"],"type":"DRUG"},{"name":"Pemetrexed","otherNames":["Alimta"],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-23","lead_sponsor":"Takeda","official_title":"A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2026-09-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1","timeFrame":"Up to approximately 40 months after the first participant is randomized"}],"references":[{"citation":"Janne PA, Wang BC, Cho BC, Zhao J, Li J, Hochmair M, Peters S, Besse B, Pavlakis N, Neal JW, Kato T, Wu YL, Nguyen D, Lin J, Lin J, Vranceanu F, Szumski A, Lin HM, Fram RJ, Mok TSK. First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial. J Clin Oncol. 2025 May;43(13):1553-1563. doi: 10.1200/JCO-24-01269. Epub 2025 Jan 29.","pmid":"39879577","type":"DERIVED"}],"start_date":{"date":"2020-01-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations","url":"https://clinicaltrials.gov/study/NCT04129502"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/exclaim-2-nct04129502"}