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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR