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

• Status: Unknown status
• Trial end date: 1969-12-31

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

• Phase: Phase 2

Details

• Lead Sponsor: Advaxis, Inc.
• Treatments: Pemetrexed