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Spots Global Cancer Trial Database for First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

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Trial Identification

Brief Title: First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin

Official Title: A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Study ID: NCT00982111

Study Description

Brief Summary: The research study is testing the investigational drug necitumumab 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 pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.

Detailed Description: Multinational, randomized, multicenter, open-label Phase 3 study of 633 participants with advanced, nonsquamous (Stage IV) NSCLC. Participants will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in 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 (computed tomography or magnetic resonance imaging) of disease status 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

ImClone Investigational Site, Nyack, New York, United States

ImClone Investigational Site, Kogarah, New South Wales, Australia

ImClone Investigational Site, Hobart, Tasmania, Australia

ImClone Investigational Site, East Bentleigh, Victoria, Australia

ImClone Investigational Site, Rankweil, , Austria

ImClone Investigational Site, Wien, , Austria

ImClone Investigational Site, Wien, , Austria

ImClone Investigational Site, Duffel, , Belgium

ImClone Investigational Site, Liège, , Belgium

ImClone Investigational Site, Namur, , Belgium

ImClone Investigational Site, Barretos - SP, , Brazil

ImClone Investigational Site, Brasilia, Distrito Federal, , Brazil

ImClone Investigational Site, Goiania - GO, , 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, Ribeirão Preto - SP, , Brazil

ImClone Investigational Site, Salvador, , Brazil

ImClone Investigational Site, Santo Andre - SP, , Brazil

ImClone Investigational Site, São Paulo - SP, , Brazil

ImClone Investigational Site, Montreal, Quebec, Canada

ImClone Investigational Site, Pula, , Croatia

ImClone Investigational Site, Caen, , France

ImClone Investigational Site, Paris, , France

ImClone Investigational Site, Berlin, , 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, 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, Mainz, , Germany

ImClone Investigational Site, München, , Germany

ImClone Investigational Site, Münster, , 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, Budapest, , Hungary

ImClone Investigational Site, Budapest, , Hungary

ImClone Investigational Site, Deszk, , 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, Parma, , Italy

ImClone Investigational Site, Perugia, , Italy

ImClone Investigational Site, Olsztyn, , Poland

ImClone Investigational Site, Otwock, , Poland

ImClone Investigational Site, Poznan, , Poland

ImClone Investigational Site, Radom, , Poland

ImClone Investigational Site, Szczecin, , Poland

ImClone Investigational Site, Wroclaw, , Poland

ImClone Investigational Site, Coimbra, , Portugal

ImClone Investigational Site, Lisboa, , 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, Sibiu, , Romania

ImClone Investigational Site, Ivanovo, , Russian Federation

ImClone Investigational Site, Kirov, , Russian Federation

ImClone Investigational Site, Omsk, , 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, Yaroslavi, , Russian Federation

ImClone Investigational Site, Bratislava, , Slovakia

ImClone Investigational Site, Nitra, , Slovakia

ImClone Investigational Site, Bloemfontein, Free State, South Africa

ImClone Investigational Site, Pretoria, Gauteng, South Africa

Imclone Investigational Site, Sevilla, Andalucia, 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, L'Hospitalet de Llobregat, , Spain

ImClone Investigational Site, Aberdeen, , United Kingdom

ImClone Investigational Site, Bournemouth, , United Kingdom

ImClone Investigational Site, Edinburgh, , United Kingdom

ImClone Investigational Site, Guildford, , United Kingdom

ImClone Investigational Site, Leeds, , United Kingdom

ImClone Investigational Site, Preston, , United Kingdom

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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