A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
NCT ID: NCT01185847
Last Updated: 2016-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2010-11-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A non-squamous
RO5083945
intravenously, until disease progression
cisplatin
standard treatment, up to 6 cycles
pemetrexed
standard treatment, up to 6 cycles
A squamous
RO5083945
intravenously, until disease progression
cisplatin
standard treatment, up to 6 cycles
gemcitabine
standard treatment, up to 6 cycles
B non-squamous
cisplatin
standard treatment, up to 6 cycles
pemetrexed
standard treatment, up to 6 cycles
B squamous
cisplatin
standard treatment, up to 6 cycles
gemcitabine
standard treatment, up to 6 cycles
Interventions
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RO5083945
intravenously, until disease progression
cisplatin
standard treatment, up to 6 cycles
gemcitabine
standard treatment, up to 6 cycles
pemetrexed
standard treatment, up to 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer
* At least 1 measurable disease lesion as per RECIST criteria
* Confirmed presence of EGFR in tumor tissue
* ECOG performance status 0-1
* Adequate hematological, renal and liver function
Exclusion Criteria
* Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
* Symptomatic or active CNS metastases
* Recent history of poorly controlled hypertension (systolic \>180mmHg or diastolic \>100mmHg)
* Requirement for steroids \> 40 mg prednisolone
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Charleroi, , Belgium
Leuven, , Belgium
Liège, , Belgium
Caen, , France
Marseille, , France
Saint-Herblain, , France
Toulouse, , France
Bad Berka, , Germany
Cologne, , Germany
Gauting, , Germany
Großhansdorf, , Germany
Heidelberg, , Germany
Mainz, , Germany
Mannheim, , Germany
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Ancona, The Marches, Italy
Lido di Camaiore, Tuscany, Italy
Livorno, Tuscany, Italy
Perugia, Umbria, Italy
Lodz, , Poland
Otwock, , Poland
Warsaw, , Poland
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Seville, Sevilla, Spain
London, , United Kingdom
Countries
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Other Identifiers
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2010-018945-72
Identifier Type: -
Identifier Source: secondary_id
BP22349
Identifier Type: -
Identifier Source: org_study_id
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