This study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Patients were randomized 2:1 to immune single-agent maintenance therapy in combination with hyperfractionated high-dose radiotherapy and immune single-agent maintenance therapy after being assessed by the investigator as otherwise eligible for enrollment. Patients in both arms received maintenance therapy with the PD-L1 inhibitor, atezolizumab or dulvedolizumab, until disease progression, unacceptable toxicity, or loss of clinical benefit. Patients in the combined radiotherapy arm required hyperfractionated high-dose (54 Gy) radiotherapy twice daily for residual disease in the chest. Each patient will be followed for approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Twice-daily thoracic radiotherapy at a dose of 54 Gy in 30 fractions with IMRT and VMAT
atezolizumab 1200 mg Q3W or durvalumab 1500 mg Q4W
Overall survival (OS)
Time frame: From randomization to the date of death due to any cause, assessed up to 4 years
Progression-free survival (PFS)
Time frame: From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 4 years
Landmark analyses of survival
Time frame: 1-year and 2-year landmark analysis of OS and 6-month and 1-year landmark analysis of PFS
Best overall response (BOR)
BOR is the percentage of participants who have a CR or a PR, as determined by investigators according to RECIST v1.1.
Time frame: Up to 4 years
Confirmed objective response rate (cORR)
cORR is defined as either a confirmed CR or PR on two consecutive evaluations ≥ 4 weeks apart, as determined by investigators according to RECIST v1.1.
Time frame: Up to 4 years
Incidence and severity of adverse events
Time frame: From randomization to 30 days after the end of study treatment
Jun Zhao
CONTACT
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