CYPRESS 2

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