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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2032-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Limited Stage Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All enrolled patients received toripalimab and JS004 Combined With etoposide and platinum Chemotherapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy

In this arm, 30 patients with limited-stage small cell lung cancer will receive 4 circles of neoadjuvant toripalimab and JS004 combined with etoposide and platinum chemotherapy. And those resectable after neoadjuvant therapy will be treated with surgery. Postoperative patients receive two cycles of toripalimab and JS004 combined with etoposide and platinum chemotherapy. then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.

Group Type EXPERIMENTAL