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Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy


Inclusion Criteria:



- Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to
curative surgery or radiotherapy

- At least one prior chemotherapy for palliative therapy

- Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status
assessment

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria:

- Concurrent administration of any other tumor therapy

- Pregnant 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:

Overall Survival

Outcome Description:

Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.

Outcome Time Frame:

baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)

Safety Issue:

Yes

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:

10717

NCT ID:

NCT00391274

Start Date:

October 2006

Completion Date:

June 2010

Related Keywords:

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

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