Status:

COMPLETED

Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

Lead Sponsor:

Eli Lilly and Company

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (...

Eligibility Criteria

Inclusion

  • Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
  • Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
  • Have 'never smoked' (defined as having smoked \<100 cigarettes during his/her lifetime)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion

  • Concurrent administration of any other tumor therapy
  • Other co-existing malignancies
  • Pregnancy or breast feeding
  • Serious concomitant disorders
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2010

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT00409006

Start Date

February 1 2007

End Date

May 1 2010

Last Update

September 9 2010

Active Locations (7)

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Page 1 of 2 (7 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fujian, China, 350014

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Qingdao, China, 266003

3

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Shanghai, China, 201900

4

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seoul, South Korea, 137-701