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A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy


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

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Trial Information

A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy


Inclusion Criteria:



- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
lung cancer (NSCLC) that is not amenable to curative therapy.

- Patients must have been previously treated with one platinum-containing chemotherapy
regimen for locally advanced or metastatic disease. Patients are also eligible if
they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant
chemotherapy, but must have received an additional chemotherapy regimen upon
recurrence.

- No more than two prior systemic anti-cancer therapies will be allowed.

- Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior
radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed
at least 2 weeks before study enrollment, and the patient must have recovered from
the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

- Pregnancy.

- Breast-feeding.

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.

- Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a
5-day period.

- 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 Time Frame:

baseline to date of death from any cause

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:

United States: Food and Drug Administration

Study ID:

8433

NCT ID:

NCT00078260

Start Date:

December 2003

Completion Date:

April 2008

Related Keywords:

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

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