A Randomized Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Combination Therapy With Serplulimab and RT in Patients With ES-SCLC Who Have Not Progressed After Treat With Serplulimab Combined Chemotherapy
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .
• Voluntary participation in clinical studies; fully understand, be informed about the study and have signed the informed consent form (ICF).
• Male or female aged ≥ 18 and ≤ 75 years, at the time of signing the ICF.
• Willingness to follow and ability to complete all trial procedures.
• Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
• No prior systemic therapy for ES-SCLC；at the end of the combination chemotherapy with serplulimab, the efficacy evaluation is CR, PR, or SD.
• At least one measurable lesion as assessed according to RECIST 1.1 , lesions that have received radiation therapy in the past are only considered measurable if they show clear progression.
• An ECOG PS score of 0 or 1.
• An expected survival ≥ 3 months.
• Normal major organ functions
⁃ For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
⁃ Negative human immunodeficiency virus (HIV) test at screening
⁃ Negative hepatitis B surface antigen (HBsAg) test at screening
⁃ Positive hepatitis B surface antibody (HBsAb) test at screening, and positive hepatitis B virus core antibody (HBcAb), no HBV-DNA test is required; or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
⁃ Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.
⁃ For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
⁃ For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.