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OncoMatch/Clinical Trials/NCT06954246

A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Is NCT06954246 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including MHB088C for and Topotecan for small cell lung cancer extensive stage.

Phase 3RecruitingQilu Pharmaceutical Co., Ltd.NCT06954246Data as of May 2026

Treatment: MHB088C for · Topotecan · Irinotecan · PaclitaxelThis study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: CD276 any tested (testing required; no eligibility threshold specified)

Disease stage

Required: Stage IV

Extensive-stage SCLC with disease progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Must have received: platinum-based chemotherapy

disease progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy

Must have received: anti-PD-1 therapy

disease progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy

Must have received: anti-PD-L1 therapy

disease progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy

Cannot have received: topoisomerase I inhibitor (topotecan, irinotecan)

Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads.

Cannot have received: B7-H3-targeted therapy

Prior B7-H3-targeted therapy.

Cannot have received: chemotherapy

Exception: within 4 weeks prior to the first administration of study drug

Receipt of chemotherapy within 4 weeks prior to the first administration of study drug

Cannot have received: radiotherapy

Exception: within 4 weeks prior to the first dose

receipt of radiotherapy ... within 4 weeks prior to the first dose

Cannot have received: biologics

Exception: within 4 weeks prior to the first dose

receipt of biologics ... within 4 weeks prior to the first dose

Cannot have received: endocrine therapy

Exception: within 4 weeks prior to the first dose

receipt of endocrine therapy ... within 4 weeks prior to the first dose

Cannot have received: immunotherapy

Exception: within 4 weeks prior to the first dose

receipt of immunotherapy ... within 4 weeks prior to the first dose

Cannot have received: other anti-tumor therapy

Exception: within 4 weeks prior to the first dose

receipt of other anti-tumor therapy ... within 4 weeks prior to the first dose

Lab requirements

Blood counts

Sufficient bone marrow and organ function

Kidney function

Sufficient bone marrow and organ function

Liver function

Sufficient bone marrow and organ function

Sufficient bone marrow and organ function

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

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