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

Inclusion Criteria:

• Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligiblefor 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 thestudy 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 studymedication

• 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 toenrollment.

• The patient has undergone major surgery within 28 days prior to enrollment exceptstaging mediastinoscopy, diagnostic Video Assisted Thoracoscopic Surgery (VATS) orimplantation 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