Phase 3 Study of Toripalimab and Tifcemalimab for Limited-stage Small Cell Lung Cancer
This study is testing two drugs, toripalimab and tifcemalimab, alone or in combination, as a treatment after initial chemoradiotherapy for limited-stage small cell lung cancer (LS-SCLC). LS-SCLC is a type of lung cancer that has not spread widely. Toripalimab targets a protein called PD-1, and tifcemalimab targets BTLA; both are monoclonal antibodies (a type of immune therapy). The goal is to see if these treatments can help patients live longer and prevent the cancer from growing. You might be able to join if you are 18 or older, have confirmed LS-SCLC, and your cancer has not worsened after your initial chemoradiotherapy. The study is currently unclear about its recruitment status.
- Study design
- This is a Phase 3, randomized, double-blind, placebo-controlled study involving 756 participants. Participants will be assigned to one of three groups to receive toripalimab alone, tifcemalimab in combination with toripalimab, or placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for overall survival for up to 3 years and for progression-free survival for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
At a glance
Conditions
Where it's being run
76 sites across 13 statesWho to contact
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What this trial measures
- Overall survival (OS)up to 3years
To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by OS
- OSup to 3years
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"
- Progression-free survival (PFS)up to 2years
To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS.
- Progression-free survival (PFS)up to 2years
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.