RecruitingPhase 2NCT06256237

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

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


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding toripalimab and JS004 (two immune checkpoint drugs) to pre-operative chemotherapy before surgery improves outcomes in patients with limited-stage small cell lung cancer (SCLC). Limited-stage means the cancer is still confined to one side of the chest and has not spread widely. The aim is to shrink the tumor before surgery using this combined approach. **You may be eligible if...** - You are 18 or older with confirmed limited-stage SCLC (confined to one lung area, no widespread spread) - You are healthy enough for surgery and your lung function can handle it - Your tumor is measurable on imaging and expected to be completely removable - Your general health is good (ECOG performance status 0 or 1) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have had prior systemic treatment for this cancer - You have serious autoimmune disease or other medical conditions making immunotherapy unsafe - Your organs (liver, kidney, blood) are not functioning adequately Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJS004

Specified dose on specified days.

DRUGToripalimab

Specified dose on specified days.

PROCEDUREsurgery

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

DRUGEtoposide

Specified dose on specified days.

DRUGPlatinum

Specified dose on specified days.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, China

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NCT06256237


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