The primary objective of this open-label study is to demonstrate an improvement in overall survival. Secondary objectives are evaluation of safety, overall response rate, time to progression, and progression free survival.
Relapsed or refractory non-small cell lung cancer (NSCLC) patients who have failed at least two lines of treatment including standard chemotherapy and/or an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor are eligible to enroll in the study.
Patients who meet all eligibility criteria will receive Talotrexin (PT-523) on a 21-day cycle. Myelosuppresion and mucositis were the dose limiting toxicities of the preceding phase I portion of the trial that determined the recommended phase II dose of Talotrexin in this setting.
“Antifolates clearly have a role in the management of advanced non-small cell lung cancer. These preliminary data are encouraging and support taking this drug into the phase II setting,” said Dr Jennifer Garst, assistant professor of medicine at Duke University, and an investigator on the trial commented.