Conditions: Non-small Cell Lung Cancer Metastatic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
Response rates.

Changes in tumor blood flow.

Detailed description:
To determine the objective response rates of cisplatin and gemcitabine with or without SUBATM-itraconazole in patients with chemotherapy-naïve metastatic squamous non-small cell lung cancer.

To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.

Arms:
arm 1: SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone. arm 2: Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.

Interventions: intervention 1: Cisplatin + Gemcitabine with SUBATM-itraconazole intervention 2: Cisplatin + Gemcitabine
Intervention descriptions: intervention 1: Experimental Arm intervention 2: Active Comparator

Protocol document: