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A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC

Outcome Time Frame:

22 months

Principal Investigator

Yasir Nagarwala, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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