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A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Defined as the time from randomization to the first observation of disease progression, or death due to any cause.

Outcome Time Frame:

Baseline to first observation of disease progression or death, 12 weeks up to 31 months

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

China: Food and Drug Administration

Study ID:

10918

NCT ID:

NCT00409006

Start Date:

February 2007

Completion Date:

May 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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