Evaluation of Trabedersen (OT-101) with Pembrolizumab in Patients with Newly Diagnosed Advanced Non-Small Cell Lung Cancer and positive PD-L1
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: I/II (Cancer Control)
Principal Investigator: Abughanimeh, Omar
Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu
Summary
Primary objectives:
o For phase I: To evaluate the safety and recommended phase 2 dose (RP2D) to proceed with phase II.
o For phase II: To determine the progression free survival of the novel combination of pembrolizumab and OT101 in the first line setting of NSCLC that has positive PD-L1 expression.
Primary endpoints:
o For phase I:
- Dose Limiting toxicity (DLT) and Maximum Tolerated Dose (MTD)
o For phase II:
- Progression-free survival (PFS). PFS will be defined as the time from first therapy until the first documentation of clinical progression, relapse, or death due to any cause. Patients not experiencing an event of interest will be right-censored at last known disease status.
Secondary endpoints:
o Best overall response, defined as the best overall response observed during the evaluation period (up to 12 weeks of treatment): CR, PR, SD, or PD,
o Disease control [CR + PR + stable disease (SD)]
o Best overall response according to iRECIST 1.
o Duration of response (DOR) which will defined as from time o