Studieoverzicht

Study name: JS004-008-III-SCLC: A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy

Histology	SCLC
Tumor stage	Stage I - III
Host / recruiting site 1	Erasmus MC	Enrollment	Recruiting
Therapy line	Later line (≥2L)
Design	This is a randomized, double-blind, placebo-controlled, multi-regional study. A total of 756 patients with LS-SCLC without disease progression after CRT will be enrolled and randomized in a 1:1:1 ratio to: Arm A: Tifcemalimab (200 mg intravenous infusion [IV]) combined with toripalimab (240 mg IV) on Day 1 of each 21-day cycle, which is once every 3 weeks (Q3W). Arm B: Placebo for tifcemalimab (IV) combined with toripalimab (240 mg IV) Q3W. Arm C: Placebos for both tifcemalimab and toripalimab (IV) Q3W.
Intervention	Tifcemalimab (JS004/TAB004), a recombinant humanized anti-B- and T-cell attenuator (BTLA) IgG4κ monoclonal antibody Toripalimab (JS001/TAB001), a recombinant humanized anti-PD-1 IgG4κ monoclonal antibody
Key outcome parameters	To compare and evaluate the efficacy of tifcemalimab combined with toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by overall survival (OS) and Blinded Independent Review Committee (BIRC)-assessed progression-free survival (PFS). To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS and BIRC-assessed PFS.
Key inclusion criteria	Histologically/cytologically confirmed limited-stage (Tumor Node Metastasis [TNM] Stage I-III [T any, N any, M0] by AJCC eighth edition) SCLC that can be safely treated with definitive radiation doses. Patients with Stage I or II disease must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery. Received concurrent CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-70 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy or radiotherapy (whichever occurs last).
Key exclusion criteria	Mixed SCLC and non-small cell lung cancer (NSCLC). Received sequential chemoradiotherapy for LS-SCLC. Known allergy or hypersensitivity reaction to any investigational interventions or any investigational intervention excipients.
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