A Study of Pemetrexed Maintenance With or Without ADXS11-001 Immunotherapy in Patients With Human Papillomavirus Positive (HPV+), NSCLC Following First-Line Induction Chemotherapy

Summary

* Open label * Enrollment in the order of confirmation of eligibility and HPV+ tumor status * Prospective stratification based on 3 factors, epidermal growth factor receptor (EGFR) mutation status, performance status and first-line induction chemotherapy outcome; * Randomization (2:1 ratio): (82 patients receiving the combination of pemetrexed plus ADXS11-001 vs. 42 patients receiving pemetrexed alone) * Treatment Arm: Pemetrexed plus ADXS11-001 immunotherapy * Control Arm: Pemetrexed only * Positive control: pemetrexed chemotherapy

Timeline

Start

2018-12

Primary completion

2019-03

Completion

2019-03

Drugs

Indications