A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1
Objective
To compare the efficacy of AM0010 in combination with nivolumab versus nivolumab alone in patients with metastatic Non-Small Cell Lung Cancer as measured by objective response rate.
Study Arms
- Experimental
- Active Comparator
Eligibility
- Patients must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent
- Patients must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease
- Patients with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria
- Patients that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization
NCT ID
NCT03382912
