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

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.

NCT Number	NCT06256237
Lead Sponsor	Shanghai Pulmonary Hospital, Shanghai, China
Conditions	Limited Stage Small Cell Lung Cancer
Enrollment	30 participants
Start Date	2024-04-01
Primary Completion	2027-01-31 (estimated)
Study Completion	2032-01-31 (estimated)
Updated on ClinicalTrials.gov	2024-05-29