Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
Summary
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Detailed 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).
Arms & interventions
- DrugDurvalumab 50 MG/ML
Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).
Outcome measures
Primary
Disease free survival (DFS)
To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery.
Time frame: 2 years
Secondary
Overall survival (OS)
Time frame: 3 years
Safety of the regimen
Time frame: 1 year
Safety of the regimen
Time frame: 5 years
Eligibility criteria
Study locations (1)
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908