Status:
COMPLETED
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years of age.
- Histologically documented non-small cell lung cancer (NSCLC).
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients of reproductive potential must agree to use effective contraception.
Exclusion
- Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- Prior treatment with any monoclonal antibody therapy.
- Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- Pre-existing interstitial lung disease.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Pregnant or lactating women.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01230710
Start Date
March 1 2011
End Date
September 1 2013
Last Update
March 30 2015
Active Locations (7)
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1
Bangalore, India, 560027
2
Chennai, India, 600035
3
Delhi, India, 110085
4
Hyderabad, India, 500 034