NCT05623267 Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT
| NCT ID | NCT05623267 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Limited Stage Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief Summary
The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.
Eligibility Criteria
Inclusion Criteria: 1、18 years or older. 2、Histologically or cytologically confirmed small cell lung cancer. 3、ECOG PS=0-1 at enrollment; 4、Limited-stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses). 5、Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses surgery. 6、Completion of 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy. 7、After the completion of concurrent or sequential chemoradiotherapy, prophylactic intracranial irradiation (PCI) is allowed based on the common practice of individual sites. 8、The start of concurrent radiotherapy should be no later than the last day of the second course of chemotherapy (the first day of the third cycle of chemotherapy). The interval between the end of chemotherapy cycle and beginning of radiotherapy must not exceed 35 days for sequential chemo
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