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

Lilly

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190710

9297

B9E-US-S358

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)