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Brief Title: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Official Title: A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Study ID: NCT00981058
Brief Summary: The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
Detailed Description: Multinational, randomized, multicenter, open-label, Phase III study of 1093 participants (age ≥ 18 years) with histologically- or cytologically-confirmed, stage IV squamous-cell NSCLC, who have received no prior therapy for metastatic disease, will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization). Participants will undergo radiographic assessment of disease status (computed tomography or magnetic resonance imaging) every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. After the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
ImClone Investigational Site, Chandler, Arizona, United States
ImClone Investigational Site, Fayetteville, Arkansas, United States
ImClone Investigational Site, Sacramento, California, United States
ImClone Investigational Site, Galesburg, Illinois, United States
ImClone Investigational Site, Goshen, Indiana, United States
ImClone Investigational Site, Wichita, Kansas, United States
ImClone Investigational Site, Hazard, Kentucky, United States
ImClone Investigational Site, Baltimore, Maryland, United States
ImClone Investigational Site, Jefferson City, Missouri, United States
ImClone Investigational Site, Lincoln, Nebraska, United States
ImClone Investigational Site, New York, New York, United States
ImClone Investigational Site, Akron, Ohio, United States
ImClone Investigational Site, Camp Hill, Pennsylvania, United States
ImClone Investigational Site, Memphis, Tennessee, United States
ImClone Investigational Site, Fairfax, Virginia, United States
ImClone Investigational Site, Garran, New South Wales, Australia
ImClone Investigational Site, Westmead, New South Wales, Australia
ImClone Investigational Site, Wollongong, New South Wales, Australia
ImClone Investigational Site, East Bentleigh, Victoria, Australia
ImClone Investigational Site, Geelong, Victoria, Australia
ImClone Investigational Site, Linz, , Austria
ImClone Investigational Site, Wien, , Austria
ImClone Investigational Site, Wien, , Austria
ImClone Investigational Site, Duffel, , Belgium
ImClone Investigational Site, Liege, , Belgium
ImClone Investigational Site, Namur, , Belgium
ImClone Investigational Site, Barretos, , Brazil
ImClone Investigational Site, Brasilia, Distrito Federal, , Brazil
ImClone Investigational Site, Goiania, , Brazil
ImClone Investigational Site, Ijui, , Brazil
ImClone Investigational Site, Itajai, , Brazil
ImClone Investigational Site, Lajeado, , Brazil
ImClone Investigational Site, Porto Alegre/RS, , Brazil
ImClone Investigational Site, Salvador, , Brazil
ImClone Investigational Site, Santo Andre, , Brazil
ImClone Investigational Site, Sao Paulo, , Brazil
ImClone Investigational Site, São Paulo - SP, , Brazil
ImClone Investigational Site, Saint John, New Brunswick, Canada
ImClone Investigational Site, Brampton, Ontario, Canada
ImClone Investigational Site, Saskatoon, Saskatchewan, Canada
ImClone Investigational Site, Dubrovnik, , Croatia
ImClone Investigational Site, Pula, , Croatia
ImClone Investigational site, Zagreb, , Croatia
ImClone Investigational Site, Brest Cedex, , France
ImClone Investigational Site, Caen, , France
ImClone Investigational Site, Draguignan, , France
ImClone Investigational Site, Grenoble, , France
ImClone Investigational Site, Le Mans Cedex, , France
ImClone Investigational Site, Le Mans, , France
ImClone Investigational Site, Lille, , France
ImClone Investigational Site, Lyon, , France
ImClone Investigational Site, Marseille, , France
ImClone Investigational Site, Paris, , France
ImClone Investigational Site, Paris, , France
ImClone Investigational Site, Paris, , France
ImClone Investigational Site, Paris, , France
ImClone Investigational Site, Rennes, , France
ImClone Investigational Site, Saint-Jean, , France
ImClone Investigational Site, Toulon Armées, , France
ImClone Investigational Site, Berlin, , Germany
ImClone Investigational Site, Essen, , Germany
ImClone Investigational Site, Essen, , Germany
ImClone Investigational Site, Frankfurt, , Germany
ImClone Investigational Site, Gauting, , Germany
ImClone Investigational Site, Großhansdorf, , Germany
ImClone Investigational Site, Halle, , Germany
ImClone Investigational Site, Hamburg, , Germany
ImClone Investigational Site, Hamburg, , Germany
ImClone Investigational Site, Heidelberg, , Germany
ImClone Investigational Site, Hemer, , Germany
ImClone Investigational Site, Hofheim, , Germany
ImClone Investigational Site, Karlsruhe, , Germany
ImClone Investigational Site, Lostau, , Germany
ImClone Investigational Site, Löwenstein, , Germany
ImClone Investigational Site, München, , Germany
ImClone Investigational Site, Münster, , Germany
ImClone Investigational Site, Regensburg, , Germany
ImClone Investigational Site, Regensburg, , Germany
ImClone Investigational Site, Ulm, , Germany
ImClone Investigational Site, Athens, , Greece
ImClone Investigational Site, Heraklion, Crete, , Greece
ImClone Investigational Site, Patras, , Greece
ImClone Investigational Site, Thessaloniki, , Greece
ImClone Investigational Site, Budapest, , Hungary
ImClone Investigational Site, Budapest, , Hungary
ImClone Investigational Site, Deszk, , Hungary
ImClone Investigational Site, Farkasgyepü, , Hungary
ImClone Investigational Site, Mosonmagyaróvár, , Hungary
ImClone Investigational Site, Szombathely, , Hungary
ImClone Investigational Site, Székesfehérvár, , Hungary
ImClone Investigational Site, Törökbálint, , Hungary
ImClone Investigational Site, Lido di Camaiore, Lucca, Italy
ImClone Investigational Site, Aviano, Pordenone, Italy
ImClone Investigational Site, Frosinone, , Italy
ImClone Investigational Site, Genova, , Italy
ImClone Investigational Site, Milano, , Italy
ImClone Investigational Site, Milano, , Italy
ImClone Investigational Site, Monza, , Italy
ImClone Investigational Site, Parma, , Italy
ImClone Investigational Site, Perugia, , Italy
ImClone Investigational Site, Incheon, , Korea, Republic of
ImClone Investigational Site, Jeonju-si, , Korea, Republic of
ImClone Investigational Site, Seongnam, , Korea, Republic of
ImClone Investigational Site, Seoul, , Korea, Republic of
ImClone Investigational Site, Seoul, , Korea, Republic of
ImClone Investigational Site, Seoul, , Korea, Republic of
ImClone Investigational Site, Suwon, , Korea, Republic of
ImClone Investigational Site, Cebu City, , Philippines
ImClone Investigational Site, Cebu, , Philippines
ImClone Investigational Site, Davao City, , Philippines
ImClone Investigational Site, Makati City, , Philippines
ImClone Investigational Site, Manila, , Philippines
ImClone Investigational Site, Quezon City, , Philippines
ImClone Investigational Site, Quezon City, , Philippines
ImClone Investigational Site, Olsztyn, , Poland
ImClone Investigational Site, Otwock, , Poland
ImClone Investigational Site, Poznan, , Poland
ImClone Investigational Site, Radom, , Poland
ImClone Investigational Site, Rzeszow, , Poland
ImClone Investigational Site, Szczecin, , Poland
ImClone Investigational Site, Torun, , Poland
ImClone Investigational Site, Wroclaw, , Poland
ImClone Investigational Site, Coimbra, , Portugal
ImClone Investigational Site, Lisboa, , Portugal
ImClone Investigational Site, Lisboa, , Portugal
ImClone Investigational Site, Porto, , Portugal
ImClone Investigational Site, Brasov, , Romania
ImClone Investigational Site, Bucharest, , Romania
ImClone Investigational Site, Bucharest, , Romania
ImClone Investigational Site, Cluj-Napoca, , Romania
ImClone Investigational Site, Craiova, Dolj, , Romania
ImClone Investigational Site, Iasi, , Romania
ImClone Investigational Site, Piatra Neamt, , Romania
ImClone Investigational Site, Sibiu, , Romania
ImClone Investigational Site, Ivanovo, , Russian Federation
ImClone Investigational Site, Kirov, , Russian Federation
ImClone Investigational Site, Krasnodar, , Russian Federation
ImClone Investigational Site, Moscow, , Russian Federation
ImClone Investigational Site, Omsk, , Russian Federation
ImClone Investigational Site, Smolensk, , Russian Federation
ImClone Investigational Site, St. Petersburg, , Russian Federation
ImClone Investigational Site, St. Petersburg, , Russian Federation
ImClone Investigational Site, St. Petersburg, , Russian Federation
ImClone Investigational Site, St. Petersburg, , Russian Federation
ImClone Investigational Site, Ufa, , Russian Federation
ImClone Investigational Site, Yaroslavl, , Russian Federation
ImClone Investigational Site, Belgrade, , Serbia
ImClone Investigational Site, Kragujevac, , Serbia
ImClone Investigational Site, Nis, , Serbia
ImClone Investigational Site, Sremska Kamenica, , Serbia
ImClone Investigational Site, Singapore, , Singapore
ImClone Investigational Site, Bratislava, , Slovakia
ImClone Investigational Site, Nitra, , Slovakia
ImClone Investigational Site, Poprad, , Slovakia
ImClone Investigational Site, Bloemfontein, Free State, South Africa
ImClone Investigational Site, Pretoria, Gauteng, South Africa
ImClone Investigational Site, Durban, Kwazulu-Natal, South Africa
ImClone Investigational Site, Sevilla, Andalucía, Spain
ImClone Investigational Site, Avila, Castilla Y Leon, Spain
ImClone Investigational Site, Barcelona, Cataluña, Spain
ImClone Investigational Site, Barcelona, Cataluña, Spain
ImClone Investigational Site, Terrassa, Cataluña, Spain
ImClone Investigational Site, Madrid, Communidad De Madrid, Spain
ImClone Investigational Site, Madrid, Communidad De Madrid, Spain
ImClone Investigational Site, Majadahonda, Communidad De Madrid, Spain
ImClone Investigational Site, Barcelona, , Spain
ImClone Investigational Site, L'Hospitalet de Llobregat, , Spain
ImClone Investigational Site, Madrid, , Spain
ImClone Investigational Site, Taichung, , Taiwan
ImClone Investigational Site, Taichung, , Taiwan
ImClone Investigational Site, Chiang Mai, , Thailand
ImClone Investigational Site, Songkhla, , Thailand
ImClone Investigational Site, Aberdeen, , United Kingdom
ImClone Investigational Site, Bournemouth, , United Kingdom
ImClone Investigational Site, Dundee, , United Kingdom
ImClone Investigational Site, Edinburgh, , United Kingdom
ImClone Investigational Site, Guildford, , United Kingdom
ImClone Investigational Site, Liverpool, , United Kingdom
ImClone Investigational Site, London, , United Kingdom
ImClone Investigational Site, Manchester, , United Kingdom
ImClone Investigational Site, Manchester, , United Kingdom
ImClone Investigational Site, Preston, , United Kingdom
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR