Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).

Inclusion criteria

• Age ≥ 18 years.
• Body weight >30 kg.
• Must have a life expectancy of at least 12 weeks.
• Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
• Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
• Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
• No prior systemic therapies, for small cell lung cancer.
• Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
• ECOG performance status 0-1.

Exclusion criteria

• Patients who are receiving any other investigational agents.
• Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
• Prior treatment with durvalumab.
• History of another primary malignancy except for:

• Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Superficial bladder cancer without active disease after treatment.
• Low grade prostate cancer without indication for active treatment.
• Adequately treated carcinoma in situ without evidence of disease.
• Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
• Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
• Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.