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OncoMatch/Clinical Trials/NCT07269782

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC

Is NCT07269782 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including HLX43 DOSE 1 and HLX43 DOSE 2 for non small cell lung cancer.

Phase 2RecruitingShanghai Henlius BiotechNCT07269782Data as of May 2026

Treatment: HLX43 DOSE 1 · HLX43 DOSE 2 · SerplulimabThe study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: ALK wild-type

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Required: EGFR wild-type

Disease stage

Required: Stage II, IIIA, IIIB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic or local anti-tumor therapy

Any prior systemic or local anti-tumor therapy for non-small cell lung cancer, including chemotherapy, radiotherapy, or immunotherapy

Cannot have received: immune checkpoint inhibitor

Patients who have previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.

Lab requirements

Blood counts

Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days prior to the first dose)

Kidney function

Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days prior to the first dose)

Liver function

Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days prior to the first dose)

Cardiac function

the subject must have good cardiac function and be confirmed as eligible for surgical resection with curative intent

Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days prior to the first dose); the subject must have good cardiac function and be confirmed as eligible for surgical resection with curative intent

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

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