Status:
COMPLETED
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 no...
Eligibility Criteria
Inclusion
- Adult patients, \>/=18 years of age
- 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
- Prior chemotherapy or treatment with another systemic anti-cancer agent
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01185847
Start Date
November 1 2010
End Date
September 1 2012
Last Update
January 1 2016
Active Locations (32)
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1
Charleroi, Belgium, B6000
2
Leuven, Belgium, 3000
3
Liège, Belgium, 4000
4
Caen, France, 14033