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NOT YET RECRUITING
NCT06648200
PHASE2

Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

Summary

For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. 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 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.

Official title: Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-11-01

Completion Date

2030-09-01

Last Updated

2024-10-18

Healthy Volunteers

No

Interventions

DRUG

JS004

Specified dose on specified days.

DRUG

Toripalimab

Specified dose on specified days.

DRUG

Etoposide

Specified dose on specified days.

DRUG

Platinum

Specified dose on specified days.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, China