Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

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 chemoradiotherapy.
• •9、Radiotherapy must be either total 60-66Gy over 6 weeks for the standard qd regimen or total 45Gy over 3 weeks for hyperfractionated bid schedules.
• •10、Absence of progression after concurrent/sequential chemoradiotherapy (responses should be complete response \[CR\], partial response \[PR\] and stable disease \[SD\]); 11、For patients not receiving PCI, the first dose of sugemalimab shall be administered within 42 days after the completion of chemoradiation therapy. For patients receiving PCI, the first dose of sugemalimab shall be administered within 56 days after the completion of chemoradiation therapy.
• •12、Life expectancy ≥ 12 weeks. 13、Can provide tumor tissue samples (fresh or archived) for whole exome sequencing; 14、Women of childbearing potential and fertile men must agree to use an effective contraceptive method from signing the master ICF until 180 days after the last dose of investigational product. Women of childbearing potential include premenopausal women and women who became menopausal less than 2 years ago. Women of childbearing potential must have a negative pregnancy test ≤7 days prior to the first dose of investigational product.
• •15、The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent.