Title: Sequential maintenance with thoracic radiotherapy and durvalumab (MEDI4736) monotherapy or durvalumab (MEDI4736) combinations (tremelimumab or olaparib) in patients with extensive stage-small cell lung cancer after first line platinum based chemotherapy
Principal Investigator: Alberto A Chiappori, MD, of H. Lee Moffitt Cancer Center and Research Institute
Description: Researchers are conducting a phase 1 trial of multiple maintenance regimens in patients with extensive-stage small-cell lung cancer.
Patients who achieved a response or stable disease on first-line platinum-based chemotherapy will be assigned to 1 of 4 maintenance regimens.
The first regimen is standard maintenance, consisting of thoracic radiotherapy (3 Gy in 10 fractions), followed 2-3 weeks later by durvalumab (1500 mg every 4 weeks for up to 13 doses).
The second regimen is standard maintenance plus tremelimumab (75 mg every 4 weeks for up to 4 doses). The third regimen is standard maintenance plus olaparib (300 mg twice daily). The fourth regimen is standard maintenance plus 1 dose of tremelimumab (300 mg).
The primary outcomes are the incidence of unacceptable serious adverse events and progression-free survival at 6 months. Secondary outcomes are 12-month progression-free survival and overall survival.
To be eligible for this study, patients must be 18 years of age or older and have an initial diagnosis of extensive-stage small-cell lung cancer. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by H. Lee Moffitt Cancer Center and Research Institute in collaboration with AstraZeneca.
ClinicalTrials.gov. Radiotherapy and durvalumab/durvalumab combo (tremelimumab/olaparib) for small cell lung cancer. NCT03923270. Accessed July 22, 2022.