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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor | Experimental |
| |
| Maintenance therapy with PD-L1 inhibitor | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy | Radiation | Twice-daily thoracic radiotherapy at a dose of 54 Gy in 30 fractions with IMRT and VMAT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From randomization to the date of death due to any cause, assessed up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 4 years | |
| Landmark analyses of survival | 1-year and 2-year landmark analysis of OS and 6-month and 1-year landmark analysis of PFS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anhui Shi | Contact | +8601088196087 | anhuidoctor@163.com | |
| Jun Zhao | Contact |
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IPD related to article disclosure data
Available after publication
Request by email to PI
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| atezolizumab or durvalumab | Drug | atezolizumab 1200 mg Q3W or durvalumab 1500 mg Q4W |
|
| 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. | 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. | Up to 4 years |
| Incidence and severity of adverse events | From randomization to 30 days after the end of study treatment |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000613593 | durvalumab |
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