Overview
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Description
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).
Eligibility
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.