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OncoMatch/Clinical Trials/NCT06256237

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

Is NCT06256237 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including JS004 and Toripalimab for limited stage small cell lung cancer.

Phase 2RecruitingShanghai Pulmonary Hospital, Shanghai, ChinaNCT06256237Data as of May 2026

Treatment: JS004 · Toripalimab · Etoposide · PlatinumFor 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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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Disease stage

Required: Stage III

limited stage confirmed by imageological examinations (CT, PET-CT or EBUS); Without systematic metastasis (including M1a, M1b and M1c)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anti-cancer treatment

Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment

Lab requirements

Blood counts

good function of blood system

Kidney function

good function of kidney

Liver function

good function of liver

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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