CISPLATIN (C) AND ALIMTA (A) WITH PANITUMUMAB FOR ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NS-NSCLC): A PHASE I-DOSE FINDING STUDY.

Background The treatment of NSCLC is rapidly changing since new drugs are becoming available. Recently, CA has become a standard for the first line treatment of NS-NSCLC. Previous clinical studies have shown that anti-EGFR MoAb may be added to chemotherapy, but the identification of a molecular signature can predict their activity and better define their true role. Aims In absence of data about the MTD of Panitumumab (a MoAb targeting the EGFR, potentially active in NS-NSCLC) when associated to chemotherapy, we decided to assess the optimal dose of panitumumab in combination with CA. Moreover, in view of a future phase II study, all pts will be studied for the following molecular characteristics: EGFR gene copy number (FISH); EGFR IHC; KRAS, BRAF, PI3KCA mutational status; ERCC1 and TS genes polymorphisms analysis. A particular attention will be paid to their possible correlation with outcome. Materials and methods Eligible patients must have: histological diagnosis of previously untreated, Stage IIIb or IV, NS-NSCLC, EGFR + (FISH). A minimum of 6 to a maximum of 18 patients have to be treated with panitumumab at escalating doses (i.e. the first 3 patients at 5.5 mg/kg q3w, than in absence of dose limiting toxicities (DLT) the next 3 patients at 7.2 mg/kg q3w, than in absence of DLT toxicities the next 3 patients at 9 mg/kg q3w) in association with CDDP and at standard doses. Activity and tolerability have been evaluated in terms of response rate and NCI-CTC v. 3.0. Results At the time of writing 8 patients have been screened for EGFR overexpression and 4 resulted eligible. None of the 3 patients treated with the first dose experienced a DLT, then the fourth patient is currently being treated with the second dose (7.2 mg/kg). One partial response and two disease stabilization have been Cisplatin (C) and (A) with panitumumab for advanced non-squamous non-small cell Lung cancer (NS-NSCLC): a phase I-Dose finding study. ABSTRACT 4 obtained, so far. Conclusions These very preliminary results have so far showed that panitumumab (at the present dose) can be safely associated with CA in NS-NSCLC patients. The study is currently on going.