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Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
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.
Official title: Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Single-arm, Phase 2 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-04-01
Completion Date
2032-01-31
Last Updated
2024-05-29
Healthy Volunteers
No
Conditions
Interventions
JS004
Specified dose on specified days.
Toripalimab
Specified dose on specified days.
surgery
Patients with resectable tumors after neoadjuvant therapy will be treated with surgery.
Etoposide
Specified dose on specified days.
Platinum
Specified dose on specified days.
Locations (1)
Shanghai Pulmonary Hospital
Shanghai, China