Status:

TERMINATED

A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients wit...

Eligibility Criteria

Inclusion

  • adult patients, \>=70 years of age or with ECOG PS of 2;
  • advanced (stage IIIB or IV)non-small cell lung cancer;
  • no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion

  • active brain metastasis or spinal cord suppression;
  • unstable systemic disease.

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2011

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT00940875

Start Date

June 1 2009

End Date

September 1 2011

Last Update

April 2 2015

Active Locations (17)

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Page 1 of 5 (17 locations)

1

Port Macquarie, New South Wales, Australia, 2444

2

Randwick, New South Wales, Australia, 2031

3

Sydney, New South Wales, Australia, 2139

4

Sydney, New South Wales, Australia, 2747