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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: carboplatin/paclitaxel (CP); Drug: gemcitabine/Eloxatin (GEMOX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087802

SR96669

L_9210

Details and patient eligibility

About

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).

Enrollment: 383 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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383 participants in 2 patient groups

Stratum 1

Active Comparator group

Description:

Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally

Treatment:

Drug: gemcitabine/Eloxatin (GEMOX)

Stratum 2

Active Comparator group

Description:

Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).

Treatment:

Drug: carboplatin/paclitaxel (CP)