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

Recruiting in Palo Alto (17 mi)

+68 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Eligibility 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

Treatment Details

Interventions

• Carboplatin (Platinum-based compounds)
• Gemcitabine (Alkylating agents)
• Oxaliplatin (Platinum-based compounds)
• Paclitaxel (Plant alkaloids)

Participant Groups

Group I: Stratum 2 Active Control 1 Intervention

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).

Group II: Stratum 1 Active Control 1 Intervention

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

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

🇪🇺 Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

🇨🇦 Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Comprehensive Cancer Centers of Nevada Las Vegas, NV

Interlakes Oncology & Hematology, P.C. Rochester, NY

South Florida Oncology & Hematology Consultants Plantation, FL

Hematology Oncology Associates of Illinois Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

Sanofi Lead Sponsor

References