Status:
COMPLETED
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Carcinoma，Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cel...
Eligibility Criteria
Inclusion
- Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
- Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than or equal to (≥) 12 weeks
- Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
- Adequate hematological , liver and renal function
Exclusion
- Known hypersensitivity to erlotinib or any of its excipients
- Squamous non-small cell or small cell tumors or absence of histological report
- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
- Prior exposure to inhibitors of EGFR
- Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
- Radical radiotherapy with curative intent within 28 days prior to enrollment
- Any active non-controlled systemic disease
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01153984
Start Date
June 1 2011
End Date
July 1 2015
Last Update
April 13 2017
Active Locations (9)
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1
County Hospital Alba; Oncology
Alba Iulia, Romania, 510073
2
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
Bucharest, Romania, 022328
3
Institute Of Oncology Bucharest; Medical Oncology
Bucharest, Romania, 022338
4
Spitalul de Boli Cronice Sf. Luca
Bucharest, Romania, 04195