Status:
COMPLETED
A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment 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:
PHASE3
Brief Summary
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-s...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- advanced (stage IIIB/IV)non-small cell lung cancer;
- measurable disease;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Exclusion
- prior exposure to agents directed at the HER axis;
- prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- unstable systemic disease;
- any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- brain metastasis or spinal cord compression.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00883779
Start Date
April 1 2009
End Date
December 1 2014
Last Update
December 14 2015
Active Locations (26)
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1
Beijing, China, 100021
2
Beijing, China, 100142
3
Beijing, China, 101149
4
Guangzhou, China, 510060