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RECRUITING
NCT06256237
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

JS004

Specified dose on specified days.

DRUG

Toripalimab

Specified dose on specified days.

PROCEDURE

surgery

Patients with resectable tumors after neoadjuvant therapy will be treated with surgery.

DRUG

Etoposide

Specified dose on specified days.

DRUG

Platinum

Specified dose on specified days.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, China