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Spots Global Cancer Trial Database for A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Official Title: A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

Study ID: NCT01185847

Study Description

Brief Summary: This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Charleroi, , Belgium

, Leuven, , Belgium

, Liège, , Belgium

, Caen, , France

, Marseille, , France

, Saint Herblain, , France

, Toulouse, , France

, Bad Berka, , Germany

, Gauting, , Germany

, Grosshansdorf, , Germany

, Heidelberg, , Germany

, Köln, , Germany

, Mainz, , Germany

, Mannheim, , Germany

, Milano, Lombardia, Italy

, Milan, Lombardia, Italy

, Ancona, Marche, Italy

, Lido Di Camaiore, Toscana, Italy

, Livorno, Toscana, Italy

, Perugia, Umbria, Italy

, Lodz, , Poland

, Otwock, , Poland

, Warszawa, , Poland

, Barcelona, , Spain

, Barcelona, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Madrid, , Spain

, Malaga, , Spain

, Sevilla, , Spain

, London, , United Kingdom

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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