BATTLE: Biomarker-Based Approaches of Targeted Therapy for Lung Cancer Elimination

Abstract : The Program BATTLE (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination) seeks to establish individualized targeted therapy by prospectively examining patients? tumor biomarker profiles and assigning them to corresponding targeted therapies with the expectation to yield a better clinical outcome. This novel approach will be a proof-of-principle experiment to test the benefit of molecular-based individualized targeted therapy for lung cancer patients. Specifically, the objectives of the BATTLE program are: 1) To establish a clinical trial program using biomarkers to select individualized targeted therapy for patients with chemorefractory advanced NSCLC through the implementation of molecular classification based on the status of specific targeted biomarkers and adaptive randomization via hierarchical Bayes modeling. 2) To study the molecular mechanisms of response and resistance to targeted agents to discover new signaling pathways for test in future trials. 3) To identify molecular features in tumor tissues to correlate with tumor response or resistance, and identify serum biomarkers as surrogates. 4) To investigate other targeted agents in combination to overcome the resistance due to novel signaling pathways (e.g., mTOR and PI3K/Akt) and improve treatment efficacy. BATTLE is composed of four Specific Aims with four phase II clinical trials and an umbrella protocol in Aim 1, six research projects in Aims 2 - 4, and two potential phase I trials in Aim 4. Here, we present our scientific progression the BATTLE program for the first grant year.