A Randomized Phase 2 Trial of AM0010 in Combination With Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)


To compare the efficacy of AM0010 in combination with pembrolizumab versus pembrolizumab alone in patients with metastatic Non-Small Cell Lung Cancer as measured by objective response rate.

Study Arms

  • Experimental  
  • Active Comparator


  • Patients must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent
  • Patients with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) ≥ 50%
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria
  • Patients that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization
  • Patients must be naïve to therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and ONLY if the last treatment was administered more than 12 months prior to the start of the trial treatment