title: [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)].
abstract: BACKGROUND
  Cisplatin-based chemotherapy and concurrent radiotherapy are the standard treatments for locally advanced unresectable NSCLC. New therapeutic combinations using molecular targeted drugs are needed.
  
  
  METHODS
  Eligible patients with previously untreated stage III non squamous, NSCLC will receive thoracic radiation (66 Gy) along with cisplatin (75 mg/m(2)) and pemetrexed (500 mg/m(2)) on day 1 administered intravenously every 21 days for four cycles; weekly cetuximab will be added from the first week of therapy. The primary objective of this phase II study (IFCT 0803) is to assess the disease control rate at the 16th week, one month after the completion of the treatment. Based on a two-stage Simon approach, a total of 106 patients are required with an interim analysis of the first 34 planned.
  
  
  RESULTS
  This trial will provide information on the feasibility, efficacy and tolerability of this new therapeutic combination. Should the primary objective be achieved, a phase III randomised study testing the position of cetuximab could be considered.
authors.affiliation: Unité de Cancérologie Thoracique, Hôpital Saint-Joseph, 185 Rue Raymond-Losserand, 75674 Paris cedex 14, France. jean.tredaniel@sls.aphp.fr
authors.forename: J
authors.initials: J
authors.lastname: Tredaniel
authors.forename: F
authors.initials: F
authors.lastname: Mornex
authors.forename: I
authors.initials: I
authors.lastname: Barillot
authors.forename: O
authors.initials: O
authors.lastname: Diaz
authors.forename: C
authors.initials: C
authors.lastname: Hennequin
authors.forename: C
authors.initials: C
authors.lastname: Le Pechoux
authors.forename: A
authors.initials: A
authors.lastname: Lavole
authors.forename: P
authors.initials: P
authors.lastname: Giraud
authors.forename: P-J
authors.initials: PJ
authors.lastname: Souquet
authors.forename: L
authors.initials: L
authors.lastname: Teixeira
authors.forename: F
authors.initials: F
authors.lastname: Vaylet
authors.forename: G
authors.initials: G
authors.lastname: Zalcman
authors.forename: L
authors.initials: L
authors.lastname: Baudrin
authors.forename: F
authors.initials: F
authors.lastname: Morin
authors.forename: B
authors.initials: B
authors.lastname: Milleron
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D000068818:Cetuximab; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D011879:Radiotherapy Dosage
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D000068818:Cetuximab; D002945:Cisplatin