Abstract | BACKGROUND: METHODS: We did this open-label, randomised phase 3 study at 184 investigative sites in 26 countries. Patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous non-small-cell lung cancer, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and adequate organ function and who had not received previous chemotherapy for their disease were eligible for inclusion. Enrolled patients were randomly assigned centrally 1:1 to a maximum of six 3-week cycles of gemcitabine and cisplastin chemotherapy with or without necitumumab according to a block randomisation scheme (block size of four) by a telephone-based interactive voice response system or interactive web response system. Chemotherapy was gemcitabine 1250 mg/m(2) administered intravenously over 30 min on days 1 and 8 of a 3-week cycle and cisplatin 75 mg/m(2) administered intravenously over 120 min on day 1 of a 3-week cycle. Necitumumab 800 mg, administered intravenously over a minimum of 50 min on days 1 and 8, was continued after the end of chemotherapy until disease progression or intolerable toxic side-effects occurred. Randomisation was stratified by ECOG performance status and geographical region. Neither physicians nor patients were masked to group assignment because of the expected occurrence of acne-like rash--a class effect of EGFR antibodies--that would have unmasked most patients and investigators to treatment. The primary endpoint was overall survival, analysed by intention to treat. We report the final clinical analysis. This study is registered with ClinicalTrials.gov, number NCT00981058. FINDINGS: INTERPRETATION: FUNDING: Eli Lilly and Company.
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Authors | Nick Thatcher, Fred R Hirsch, Alexander V Luft, Aleksandra Szczesna, Tudor E Ciuleanu, Mircea Dediu, Rodryg Ramlau, Rinat K Galiulin, Beatrix Bálint, György Losonczy, Andrzej Kazarnowicz, Keunchil Park, Christian Schumann, Martin Reck, Henrik Depenbrock, Shivani Nanda, Anamarija Kruljac-Letunic, Raffael Kurek, Luis Paz-Ares, Mark A Socinski, SQUIRE Investigators |
Journal | The Lancet. Oncology
(Lancet Oncol)
Vol. 16
Issue 7
Pg. 763-74
(Jul 2015)
ISSN: 1474-5488 [Electronic] England |
PMID | 26045340
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 Elsevier Ltd. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Gentamicins
- necitumumab
- Cisplatin
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Topics |
- Adult
- Age Factors
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Carcinoma, Squamous Cell
(drug therapy, mortality, pathology)
- Cisplatin
(administration & dosage)
- Disease-Free Survival
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Gentamicins
(administration & dosage)
- Humans
- Kaplan-Meier Estimate
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasm Invasiveness
(pathology)
- Neoplasm Staging
- Proportional Hazards Models
- Risk Assessment
- Sex Factors
- Survival Analysis
- Treatment Outcome
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