Klinische Studie

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(Shanghai JS004-008-III-SCLC)A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab. Limited Stage SCLC
Krankheitsentität(en) Lunge
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien-Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 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. - Histologically or cytologically confirmed LS-SCLC using the Veteran’s Administration Lung Study Group (VALSG) staging criteria (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery. - Patients must achieve a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed PD prior to study entry. - Male or female with age ≥ 18 years old at the time of informed consent.
Wesentliche Ausschlusskriterien1. Mixed SCLC and non-small cell lung cancer (NSCLC). 2. More than or less than 4 cycles of chemotherapy during CRT or received a chemotherapy regimen other than an intravenous etoposide and platinum-based regimen. 3. Received sequential chemoradiotherapy for LS-SCLC. 4. Known allergy or hypersensitivity reaction to any investigational interventions or any investigational intervention excipients. 5. Received any of the following treatments. a. Immune-mediated therapy, including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy. b. Any investigational products within 4 weeks or 5 half-lives prior to the first dose, whichever is shorter. c. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or the patient is in the follow-up period of an interventional clinical study. d. Systemic corticosteroids >10 mg/day prednisone or its equivalent or other immunosuppressive agents within 2 weeks before the first dose of the investigational intervention. Inhaled or topical use of corticosteroids are permitted. Short courses of corticosteroids (e.g., prior to intravenous contrast) within 2 weeks of the first dose of the investigational intervention are permitted. e. An antineoplastic vaccine or a live vaccine within 4 weeks prior to the first dose of the investigational intervention. f. Major surgery or serious trauma within 4 weeks prior to the first dose of the investigational intervention.
StatusStudie beendet
Ansprechpartner & KontaktUniversitätsklinikum RegensburgInnere Medizin IIStudienzentrale0941 9444475studien.pneumologie(at)ukr.de
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