Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients

Inclusion criteria

• Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection (Clinical stages I B, II and selected stage III A)
• Eastern Cooperative Oncology Group (ECOG) ≤ 1
• Sufficient pulmonary function to undergo curative lung cancer surgery
• Adequate hematological, hepatic and renal function parameters:
• Sufficient cardiac left ventricular defined as left ventricular ejection fraction (LVEF) ≥ 50% documented either by echocardiography or multigated acquisition scan (MUGA)
• Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures

Exclusion criteria

• Active or history of autoimmune disease or immune deficiency
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
• Subjects who have undergone organ transplant or allogeneic stem cell transplantation
• Uncontrolled or significant cardiovascular disease
• Patients with active neurological disease
• Active malignancy or a prior malignancy within the past 3 years
• Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication
• Peripheral polyneuropathy NCI CTCAE Grade ≥ 2
• History of gastric perforation or fistulae in past 6 months
• Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
• The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic Video Assisted Thoracoscopic Surgery (VATS) or implantation of a venous port-system.
• Any other concurrent preoperative antineoplastic treatment including irradiation
• Pregnant/Breastfeeding women
• Subjects with history of severe toxicity or life-threatening toxicity (grade 3 or 4) related to prior immune therapy
• Prior treatment with Lymphocyte-activation gene 3 (LAG-3) targeting Agent
• Previous treatment with Nivolumab or Relatlimab