This Phase II study consists of 2 parts: 1) pre-screening phase and 2) treatment phase. The pre-screening phase will investigate the presence of HRAS mutations in subjects with a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC). Subjects may participate in the pre-screening phase at initial diagnosis or following prior lines of therapy for SQ-NSCLC. The treatment phase will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations and for whom there is no curative therapy available.
Description: To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutationsMeasure: Overall Response Rate Time: From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose
Description: As there is a screening phase where HRAS mutations will be analyzed, the second outcome is to determine the frequency (%) of this mutation in the target population of this studyMeasure: Frequency of HRAS mutations Time: at the beginning of the study, day -7 to day 0
Description: Adverse events will be collected in all the patients in order to now the tolerability of the treatmentMeasure: Tolerability as Incidence of Treatment-Emergent Adverse Events of Tipifarnib Time: from the first dose of treatment until 30 days after the last dose of treatment
Single Group Assignment
There is one SNP
Non Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Subject enrolment may proceed with information available on tumor HRAS status previously generated during the pre-screening phase, but all subjects must consent to provide tumor slides (or tumor tissue block) from a prior diagnostic biopsy for a retrospective testing of RAS gene status, including T81C polymorphism, and other potential biomarkers at a central facility. --- T81C ---