A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Locally Advanced (IIIB) Unsuitable for Radiotherapy or Metastatic (IV) Non-Small-Cell Lung Cancer. (OSE2101C301)

The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.

Inclusion Criteria:
• Histologically or cytologically proven diagnosis of NSCLC that is locally advanced (stage IIIB) unsuitable for radiotherapy or metastatic (stage IV)
• Subjects with disease recurrence or progression
• Subjects must express HLA-A2 phenotype as assessed serologically

Exclusion Criteria:
• Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas). Large-cell carcinoma.
• NSCLC that is predominantly squamous cell carcinoma, and patient had docetaxel as part of his prior chemotherapy
• Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK) rearrangement.
Phase III
Rachel Sanborn, M.D.
OSE Immunotherapeutics
Brenda Fisher
  • Oncology and Hematology Care Westside
  • Providence Cancer Institute Clackamas Clinic
  • Providence Cancer Institute Franz Clinic
  • Providence Cancer Institute Newberg Clinic