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Randomized Phase II Trial to Outline the Efficacy of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/Paclitaxel) When Used as Preoperative Chemotherapy In Patients With Stage I and II NSCLC


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non Small Cell Lung

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Trial Information

Randomized Phase II Trial to Outline the Efficacy of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/Paclitaxel) When Used as Preoperative Chemotherapy In Patients With Stage I and II NSCLC


Inclusion Criteria:



- Histologically or cytologically confirmed non small cell lung cancer

- No prior chemotherapy or radiation for non small cell lung cancer

- No prior malignancy

Exclusion Criteria:

- Pregnancy or breastfeeding

- Serious concomitant disorders

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathological complete response rate, in previously untreated patients with clinical Stage I and II non-small cell lung cancer (NSCLC).

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:

5488

NCT ID:

NCT00191256

Start Date:

June 2001

Completion Date:

July 2006

Related Keywords:

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

Name

Location

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