A Trial of Carboplatin and Gemcitabine Versus Gemcitabine Alone in Patients With Non-Small-Cell Lung Cancer

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Gemcitabine (Drug); Carboplatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Official title: A Randomized Phase III Trial of Paraplatin (Carboplatin) + Gemzar Versus Gemzar Alone in Patients With Advanced Non-Small Cell Lung Cancer

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.

Secondary outcome:

To determine and compare the 1-year survival produced by combined Paraplatin (carboplatin) + Gemcitabine versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2

To determine the safety of combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2

To compare the response rate between treatment groups

To compare the changes in QOL between treatment groups

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologic or cytologic new diagnosis of NSCLC, Stage IIIB with a cytologically

positive pleural or pericardial effusion or Stage IV.

- No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of

NSCLC.

- ECOG Performance Status of 2 .

- Patients must be at least 3 weeks since major surgery. Patients must be at least 1

week since surgery, such as mediastinoscopy, pleuroscopy, or thoracostomy.

- Patients must have measurable disease, defined as lesions that can be accurately

measured in at least 1 dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.

Exclusion Criteria:

- Any prior radiation therapy to the thoracic area.

- Active and ongoing systemic infection.

- Prior radiation to greater than 25% of the bone marrow.

- ECOG PS other than 2

- Patients with a known hypersensitivity to gemcitabine and carboplatin.

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., Dallas, Texas 75204, United States

Lilly Clinical Trial Registry

Starting date: March 2004
Ending date: August 2007
Last updated: November 10, 2007