{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NADIMII","nct_id":"NCT03838159","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nadimii-nct03838159. 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":"NADIMII","arms":[{"description":"* Neoadjuvant treatment (200 mg/m3 Paclitaxel+ AUC5 Carboplatin+ 360 mg Nivolumab) will start within 1-3 days from randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.\n* Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3) .\n* Adjuvant treatment:Nivolumab: 480 mg Q4W (+/- 3 days) for 6 months (6 cycles). Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week (+ 7 days) from surgery and for 6 months.","label":"Experimental: Neo-Adjuvant Immunotherapy","type":"EXPERIMENTAL"},{"description":"* Neoadjuvant treatment (200mg/m3 Paclitaxel+ AUC5 Carboplatin). It will start within 1-3 days from randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.\n* Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3)","label":"Control: Neo-Adjuvant Chemotherapy","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-11-30","type":"ESTIMATED"},"conditions":["Non Small Cell Lung Cancer"],"enrollment":{"count":90,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Paclitaxel","otherNames":["Taxol"],"type":"DRUG"},{"name":"Carboplatin","otherNames":["Paraplatin"],"type":"DRUG"},{"name":"Nivolumab","otherNames":["Opdivo"],"type":"DRUG"}],"last_update":"2026-04-30","lead_sponsor":"Fundación GECP","official_title":"A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-11-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Evaluation of the pathological complete response (pCR)","timeFrame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months."}],"references":[{"citation":"Sierra-Rodero B, Gil-Gonzalez A, Molina-Alejandre M, Nadal E, Calvo V, Lazaro M, Insa A, Massuti B, Martinez Marti A, de Castro J, Garcia Campelo R, Gonzalez Larriba JL, Bernabe R, Domine M, Ponce Aix S, Cobo M, Camps C, Reguart N, Bosch-Barrera J, Majem M, Aguilar A, Palmero R, Blanco Clemente M, Martin-Lopez J, Munoz-Viana R, Megias D, Gutierrez-Escobedo JM, Martinez-Toledo C, Cruz-Bermudez A, Provencio M. Decoding B-cell Signatures of Complete Pathologic Response to Perioperative Chemoimmunotherapy in Non-Small Cell Lung Cancer. Clin Cancer Res. 2026 Apr 15;32(8):1499-1512. doi: 10.1158/1078-0432.CCR-25-3315.","pmid":"41805895","type":"DERIVED"},{"citation":"Provencio M, Nadal E, Gonzalez-Larriba JL, Martinez-Marti A, Bernabe R, Bosch-Barrera J, Casal-Rubio J, Calvo V, Insa A, Ponce S, Reguart N, de Castro J, Mosquera J, Cobo M, Aguilar A, Lopez Vivanco G, Camps C, Lopez-Castro R, Moran T, Barneto I, Rodriguez-Abreu D, Serna-Blasco R, Benitez R, Aguado de la Rosa C, Palmero R, Hernando-Trancho F, Martin-Lopez J, Cruz-Bermudez A, Massuti B, Romero A. Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):504-513. doi: 10.1056/NEJMoa2215530. Epub 2023 Jun 28.","pmid":"37379158","type":"DERIVED"}],"start_date":{"date":"2019-05-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"NADIM II: Neo-Adjuvant Immunotherapy","url":"https://clinicaltrials.gov/study/NCT03838159"},"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/nadimii-nct03838159"}