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

Completed · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00190710

Run by

Eli Lilly and Company

People needed

242

Starts

2004-03-01

Expected to finish

2007-08-01

Last updated by the study team

2007-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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