Study design
NSCLC, toxicity
DISEASE PROGRESSION, SOLID TUMORS, NSCLC
This was a phase Ib/II open-label study (NCT02423343) conducted between October 2015 and August 2020. The phase Ib portion of this study consisted of a dose-escalation assessment of the safety and tolerability of galunisertib administered at 50 mg daily, 50 mg twice daily (BID), 80 mg BID, or 150 mg BID in combination with nivolumab 3 mg/kg administered every two weeks in patients with advanced refractory solid tumors. The phase II portion of the trial evaluated the safety and efficacy of 150 mg BID galunisertib in combination with nivolumab at 3 mg/kg in patients with recurrent or refractory NSCLC that were immune checkpoint naive. The study did not have a fixed treatment duration, and patients received combination treatment in 28-day cycles until disease progression, intolerable toxicity or withdrawal of consent. Based on the results of a preclinical dosing schedule investigation that evaluated toxicity using animal models [