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BATTLE Grant

The BATTLE grant consists of an “umbrella trial” plus four phase II clinical trials. To be eligible for the BATTLE trials, patients must have a diagnosis of stage IIIB, stage IV, or advanced, incurable non-small cell lung cancer, confirmed by tumor biopsy and/or fine-needle aspiration, and have received at least one chemotherapy regimen.

All patients who meet the eligibility criteria are enrolled in the Umbrella trial and will undergo a tumor biomarker analysis, the results of which determine assignment to one of the four phase II clinical trials listed below. The goal is to assign a patient to the clinical trial that offers the best benefit based on the characteristics of his/her tissue biomarker profile; in other words, treatment is individualized.

Clinical Trials

The primary objective of each of the four phase II clinical studies is to determine after the second cycle of treatment (eight weeks) if the patient’s disease has progressed. This will be determined by chest X-ray, CT or MRI scan, and optional re-biopsy of the tumor. Patients with no progression of disease will continue on the treatment. Patients whose disease has progressed will not be eligible to continue treatment on that particular study, but will be eligible to pursue other treatments, such as one of the other BATTLE clinical trials:

2005-0824: Erlotinib (Tarceva™): Patients will be treated with erlotinib once daily without interruption. A four week (28 days) period of treatment will be considered one cycle of therapy. Response to treatment will be evaluated by chest X-ray, and CT or MRI scan after cycle 2 (8 weeks) and every two cycles thereafter. An optional tumor re-biopsy is obtained after cycle 2 if patient consents.

2005-0826: Erlotinib + Bexarotene: Patients will receive 4-week cycles of therapy with combination erlotinib and bexarotene. Erlotinib will be administered daily by mouth at a dose of 150mg. Bexarotene will be administered daily by mouth at a dose of 400mg/m2. Response to treatment will be evaluated by chest X-ray, and CT or MRI scan after cycle 2 (8 weeks) and every two cycles thereafter. An optional tumor re-biopsy is obtained after cycle 2 if patient consents.

2005-0825: ZD6474: Patients will receive ZD6474 daily by mouth at a dose of 300mg. At the end of two 4-week cycles, patients’ response to treatment will be evaluated by chest x-ray, CT scan or MRI, and optional re-biopsy. Response to treatment will be evaluated by chest X-ray, and CT or MRI scan after cycle 2 (8 weeks) and every two cycles thereafter. An optional tumor re-biopsy is obtained after cycle 2 if patient consents.

2005-0827: Sorafenib: Patients will receive Sorafenib twice a day by mouth at a dose of 400mg. A four-week (28 days) period of treatment will be considered one cycle of therapy. Response to treatment will be evaluated by chest X-ray, and CT or MRI scan after cycle 2 (8 weeks) and every two cycles thereafter. An optional tumor re-biopsy is obtained after cycle 2 if patient consents.

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© 2014 The University of Texas MD Anderson Cancer Center