This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
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.
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.
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.
Single group
Durvalumab 50 MG/ML
DrugFollowing 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).
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.
Overall survival (OS)
To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved overall survival (OS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. OS is measured in months from the time of surgery.
Safety of the regimen
The frequency of grade 3+ treatment-related adverse events will be reported.
Safety of the regimen
The frequency of grade 3+ all-cause adverse events will be reported.
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Alliance Foundation Trials, LLC.
Lead sponsor
AstraZeneca
Collaborator
