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Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3
Not Enrolling
Non-small Cell Lung Cancer

Thank you

Trial Information

Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

This study evaluates the use of Targretin capsules (bexarotene) in combination with
Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in
patients who have not yet received chemotherapy for their lung cancer. Every patient
receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy
cycles (approximately four months). Half of the patients are randomly assigned to receive
Targretin capsules once daily in addition to the chemotherapy. The other half is randomized
to receive a standard platinum-containing chemotherapy without Targretin capsules.

Inclusion Criteria

Patients must have:

- Pathologic (histologic or cytologic) confirmation of NSCLC

- Stage IIIB with malignant pleural effusion or Stage IV disease

- At least one measurable or evaluable NSCLC lesion that has not been previously
irradiated unless radiation therapy was more than three weeks prior to entry in the
study and the lesion has been shown to have progressed subsequent to the radiation

- ECOG performance status 0 or 1

- Adequate organ system function

- Fasting serum triglycerides that are within the age-adjusted normal range (or
normalized with appropriate intervention such as antilipid therapy prior to the
initiation of Targretin capsule therapy).

Patients must be able to complete at least four cycles of combination chemotherapy (i.e.,
approximately four months)

Patients must not have had:

- Brain metastasis

- Prior chemotherapy for NSCLC

- Prior platinum-based chemotherapy for any indication

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

From date of randomization to date of death

Safety Issue:


Principal Investigator

Mack Mabry, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ligand Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

March 2005

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Targretin
  • Retinoid
  • Bexarotene
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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