DiseaseMedical Area Oriented Research
Disease-Oriented Research – Respiratory System Tumors
Medical Oncology Division of the Respiratory System Aaron GOLDHIRSCH, MD Director (ad interim)
STAFF Director Medical Oncology Unit of the Respiratory system: Tommaso De Pas, MD Deputy Directors: Chiara Catania, MD, Cristina Noberasco, MD Consultant: Gianluca Spitaleri, MD, Angelo Delmonte, MD Translational research: Francesca Toffalorio, MD, PhD Clinical Fellow: Mariacarmela Santarpia, MD, PhD Research Nurses: Veronica Brunelli Data Managers: Sabrina Boselli, Sparacio Eleonora, Valentina Liparulo, Letizia Sirica Secretary: Monica Croce
Activities 2012.
The Medical Oncology Division of the Respiratory system was established to guarantee the best of care to patients with thoracic malignancies. This goal is mainly pursued by the creation of a dedicated staff, who accurately takes care of the patient in each stage of disease, and promotes appropriate clinical trials to test new drugs and novel therapies. An intensive collaboration with the Division of Thoracic Surgery make sure the correct follow-up of the patient from the pre- to the post-surgical time. One of the main research fields of the Division is nonsmall cell lung cancer (NSCLC). Several phase I, II and III clinical trials are currently opened to cure this kind
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IEO — Scientific Report 2012 — Ongoing Research 2013
of disease, both in the metastatic and adjuvant setting. The drugs currently investigated vary among targeted therapy (the drugs target specific proteins of pivotal pathways altered in NSCLC), combined therapy and immunotherapy. In detail, the following clinical trials are currently opened: Target therapies: 1. ALK (Anaplastic Lymphoma Kinase) pathway • Crizotinib (three trials evaluate the efficacy and safety of PF-02341066, Crizotinib, a small-molecule able to inhibit the c-Met/HGFR receptor and the anaplastic lymphoma kinase: a phase II, open-label single arm study to evaluate the efficacy and safety of Crizotinib and two phase III, randomized, openlabel study of Crizotinib versus standard of care chemotherapy, in patients with NSCLC either pretreated and chemonaive, harboring a translocation or inversion involving the ALK gene locus) • LDK378 (phase I, II and III studies with the ALK inhibitor LDK378 in patients with advanced NSCLC progressed to Crizotinib or as first line treatment) • LDK378 plus AUY922 (phase Ib/II heat shock protein 90 inhibitor in patients with advanced NSCLC progressed to ALK-inhibitors) • RO5424802 (phase I/II of RO5424802, a new ALK inhibitor, in patients with ALK mutations who failed crizotinib treatment) 2. EGFR (Epidermal Growth Factor Receptor) pathway • MetMAb (phase III study of Monoclonal antibody directed against the cMet receptor, in combination with erlotinib, in patients with advanced Met positive NSCLC) • INC280 (phase IB/II study of INC280, a Met inhibitor, in association to gefitinib, in patients progressed to EGFR inhibitors carrying cMet amplification) • SAR125844 (phase I study of SAR125844, a Met inhibitor, in patients with solid tumors harboring cMet amplification or in phospho-Met positive tumors)
• Afatinib (phase IIIb study of Afatinib, an irreversible inhibitor of EGFR and HER2, in patients with advanced NSCLC EGFR-TKI inhibitors naive) • AUY922 (phase II study of AUY922 in patients with advanced NSCLC progressed to EGFR-TKI inhibitors) • Dacomitinib (phase III study of dacomitinib versus gefitinib as first line treatment in patients with EGFR mutated tumors) • PROSE study (this phase III study is aimed at prospectively evaluating the value of the proteomic profile as a predictive factor for erlotinib and chemotherapy efficacy in patients with inoperable non-small cell lung cancer)
• TRIGGER (phase II study of erlotinib in patients with locally advanced or metastatic NSCLC who present activating mutation in the tyrosine kinase domain of EGFR) 3. Ras pathway • MEK Inhibitor (phase II study of GSK1120212, a specific MEK1/2 inhibitor, in patients with stage IIIb and IV NSCLC harboring mutations of KRas, NRas, BRaf and MEK1) 4. PI3K/PTEN pathway • BKM120 (tree phase II studies of BKM120, a PI3K inhibitors, in NSCLC advanced patients, mostly of squamous cell type, with activated PI3K, alone or in combination with chemotherapy)
IEO — Scientific Report 2012 — Ongoing Research 2013
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