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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Page 1 of 7 (26 locations)

1

Beijing, China, 100021

2

Beijing, China, 100142

3

Beijing, China, 101149

4

Guangzhou, China, 510060