Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive

• One (1) unidimensionally measurable lesion

• ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1

• Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.

• Recovery in full from any previous surgical procedure

• No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease

Exclusion Criteria:

• Hypersensitivity to any of the 4 study drugs

• Concurrent immunotherapy or participation in any investigational drug study within 4 weeks

• Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft

• History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)

• Patient is a pregnant or lactating female