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eligibility_summary
Eligible: histologic/cytologic ES-SCLC per VALSG, no prior systemic therapy, adequate organ function, agrees to contraception. Excluded: mixed SCLC, severe allergy to monoclonal antibodies, hypersensitivity to carboplatin/etoposide, pregnant or breastfeeding, history of psychotropic drug abuse/addiction, any condition likely to cause early study termination per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in first-line extensive-stage SCLC testing HLX07 (recombinant humanized anti-EGFR monoclonal antibody) + HLX10 (recombinant humanized anti-PD-1 monoclonal antibody) with carboplatin/etoposide. Mechanisms: HLX07 blocks EGFR on tumor cells, inhibiting downstream signaling (MAPK/PI3K) and may induce ADCC, HLX10 blocks PD-1 on T cells, reversing PD-1/PD-L1–mediated suppression to enhance antitumor T-cell activity, carboplatin (platinum DNA crosslinker) and etoposide (topoisomerase II inhibitor) induce DNA damage/apoptosis. Targets: EGFR on tumor cells, PD-1 on T cells, DNA replication/repair in rapidly dividing SCLC cells.