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Toripalimab Alone or With Tifcemalimab as Consolidation Therapy in LS-SCLC
NCT06095583Phase 3
Key facts
- Status
- Recruiting
- Start
- Nov 2023
- Primary completion
- Jul 2027
- Countries
- 6
- Modality
- Immune Checkpoint Inhibitors, Antibody Conjugates, Recombinant Proteins and Enzymes
- Conditions
- small cell lung cancer (SCLC)
01
Overview
Phase 3, randomised, double-blind trial of tifcemalimab and toripalimab in small cell lung cancer (SCLC) (3 arms), sponsored by Shanghai Junshi Biosciences Co., Ltd. Primary endpoints: Overall Survival at 3 years and Progression-Free Survival at 2 years. Started Nov 2023; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Experimental group A
Tifcemalimab (200 mg IV) and toripalimab (240 mg IV) every 3 weeks
Experimental group B
Placebo for tifcemalimab (IV) and toripalimab (240 mg IV) every 3 weeks
Placebo group C
Placebos for both tifcemalimab and toripalimab (IV) every 3 weeks
03
Who it enrols
Adult patients with limited-stage small cell lung cancer who have not progressed following platinum-based chemoradiotherapy, with ECOG PS 0-1, adequate organ function, and no active autoimmune disease, interstitial lung disease, or active infections like HIV, HBV, or HCV.
04
Endpoints
Primary
Overall Survival
Progression-Free Survival
Secondary
1-year Overall Survival rate
2-year Overall Survival rate
Objective Response Rate
Disease Control Rate
Duration of Response
Safety (adverse events and abnormal laboratory parameters)
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