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
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
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
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Ministry of Health
Study ID:
BP22349
NCT ID:
NCT01185847
Start Date:
November 2010
Completion Date:
November 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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