{"preliminary_commentary":{"by_channel":{"x_thread":4},"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":[["erlotinib"]],"indication":"stage IIIA-N2 EGFR-mutant non-small-cell lung cancer","name":"EMERGING-CTONG 1103","nct_id":"NCT01407822","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=emerging-ctong-1103-nct01407822. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"EMERGING","arms":[{"description":"In the neo-adjuvant treatment phase, erlotinib 150 mg/day taken orally for 6 weeks(42 days).In the post-surgery phase, erlotinib 150mg/day taken orally for 1 year or till disease progression or unacceptable toxicity.","label":"Erlotinib arm","type":"EXPERIMENTAL"},{"description":"In the neo-adjuvant treatment phase, patient will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 1 of a 3-week schedule for 2 cycles. In the post-surgery phase, Gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 1 of a 3-week schedule for 2 cycles or till disease progression or unacceptable toxicity.","label":"Chemo arm","type":"ACTIVE_COMPARATOR"}],"collaborators":["Guangdong Provincial People's Hospital","Tianjin Medical University Cancer Institute and Hospital","Jilin Provincial Tumor Hospital","Jiangsu Cancer Institute & Hospital","Zhejiang Cancer Hospital","Peking University Cancer Hospital & Institute","Sun Yat-sen University","West China Hospital","The First Affiliated Hospital of Dalian Medical University","Peking University People's Hospital","Xi'an Jiaotong University","Shanghai Zhongshan Hospital","Guangzhou General Hospital of Guangzhou Military Command","The First Affiliated Hospital of Guangzhou Medical University","Fujian Medical University Union Hospital","Linyi Tumour Hospital","Northern Jiangsu People's Hospital"],"completion_date":{"date":"2022-12","type":"ESTIMATED"},"conditions":["Non-small Cell Lung Cancer"],"enrollment":{"count":72,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Erlotinib","otherNames":["Tarceva"],"type":"DRUG"},{"name":"Gemcitabine/cisplatin","otherNames":["Gemzar/cisplatin"],"type":"DRUG"}],"last_update":"2018-09-11","lead_sponsor":"Guangdong Association of Clinical Trials","official_title":"A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of GC as (Neo)Adjuvant Treatment in Stage IIIA-N2 NSCLC With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING)","overall_status":"UNKNOWN","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2018-04-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"The objective response rate (ORR) in neoadjuvant treatment","timeFrame":"Tumor response will be evaluated after 6 weeks of induction treatment (during day 43 to day 49)."}],"references":[{"citation":"Kappers I, Klomp HM, Burgers JA, Van Zandwijk N, Haas RL, van Pel R. Neoadjuvant (induction) erlotinib response in stage IIIA non-small-cell lung cancer. J Clin Oncol. 2008 Sep 1;26(25):4205-7. doi: 10.1200/JCO.2008.16.3709. No abstract available.","pmid":"18757336","type":"BACKGROUND"},{"citation":"Takamochi K, Suzuki K, Sugimura H, Funai K, Mori H, Bashar AH, Kazui T. Surgical resection after gefitinib treatment in patients with lung adenocarcinoma harboring epidermal growth factor receptor gene mutation. Lung Cancer. 2007 Oct;58(1):149-55. doi: 10.1016/j.lungcan.2007.04.016. Epub 2007 Jun 4.","pmid":"17548126","type":"BACKGROUND"},{"citation":"Haura EB, Sommers E, Song L, Chiappori A, Becker A. A pilot study of preoperative gefitinib for early-stage lung cancer to assess intratumor drug concentration and pathways mediating primary resistance. J Thorac Oncol. 2010 Nov;5(11):1806-14. doi: 10.1097/JTO.0b013e3181f38f70.","pmid":"20881637","type":"BACKGROUND"},{"citation":"Rizvi NA, Rusch V, Pao W, Chaft JE, Ladanyi M, Miller VA, Krug LM, Azzoli CG, Bains M, Downey R, Flores R, Park B, Singh B, Zakowski M, Heelan RT, Shen R, Kris MG. Molecular characteristics predict clinical outcomes: prospective trial correlating response to the EGFR tyrosine kinase inhibitor gefitinib with the presence of sensitizing mutations in the tyrosine binding domain of the EGFR gene. Clin Cancer Res. 2011 May 15;17(10):3500-6. doi: 10.1158/1078-0432.CCR-10-2102. Epub 2011 May 10.","pmid":"21558399","type":"BACKGROUND"},{"citation":"Zhong WZ, Yan HH, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang XZ, Yan WP, Liao RQ, Yang JJ, Zhang XC, Liu SY, Zhou Q, Wu YL. Erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non-small-cell lung cancer: final overall survival analysis of the EMERGING-CTONG 1103 randomised phase II trial. Signal Transduct Target Ther. 2023 Feb 24;8(1):76. doi: 10.1038/s41392-022-01286-3.","pmid":"36823150","type":"DERIVED"},{"citation":"Zhong WZ, Chen KN, Chen C, Gu CD, Wang J, Yang XN, Mao WM, Wang Q, Qiao GB, Cheng Y, Xu L, Wang CL, Chen MW, Kang X, Yan W, Yan HH, Liao RQ, Yang JJ, Zhang XC, Zhou Q, Wu YL. Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Treatment of Stage IIIA-N2 EGFR-Mutant Non-Small-Cell Lung Cancer (EMERGING-CTONG 1103): A Randomized Phase II Study. J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13.","pmid":"31194613","type":"DERIVED"}],"start_date":{"date":"2011-12-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT01407822"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/emerging-ctong-1103-nct01407822"}