drugset / Trial / NCT06256237

Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial

NCT06256237

Phase 2 Recruiting 30 enrolled Shanghai Pulmonary Hospital, Shanghai, China
NaSingle-groupOpen-labelTreatment

Summary

For limited-stage small cell lung cancer (SCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients cannot achieve a complete pathological response (CPR). A new immunotherapeutic strategy is needed to achieve a higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells\' function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus etoposide and platinum Chemotherapy in limited-stage SCLC.

Timeline

Start
2024-04-01
Primary completion
2027-01-31
Completion
2032-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tifcemalimab Monoclonal antibody
Subject Toripalimab Monoclonal antibody
Background Etoposide Small molecule