eligibility_summary
Adults (≥18) with good organ function, ECOG 0–1, expected survival ≥3 months, histologically confirmed advanced/recurrent/metastatic non-squamous NSCLC, measurable per RECIST 1.1, and high EGFR expression (H-score ≥200). Excludes squamous NSCLC (unless adenoid-dominant, squamous <5%), prior EGFR inhibitors, active severe infection, symptomatic CNS mets unless treated/stable, and other malignancy within 5 years (except cured CIS cervix/basal cell).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05215925 tests HLX07, a recombinant humanized anti-EGFR monoclonal antibody, in advanced non-squamous NSCLC with high EGFR expression (H-score ≥200). Arms: A) HLX07 + carboplatin + pemetrexed, B) HLX07 + docetaxel, C) HLX07 alone. Drug types and mechanisms: HLX07 (mAb immunotherapy) binds EGFR (ErbB1), blocking ligand binding and receptor activation, suppressing downstream RAS/RAF/MEK/ERK and PI3K/AKT signaling to inhibit tumor cell proliferation and survival. Carboplatin (platinum) crosslinks DNA, inducing apoptosis in rapidly dividing cells. Pemetrexed (antifolate) inhibits thymidylate synthase and other folate-dependent enzymes, reducing nucleotide synthesis. Docetaxel (taxane) stabilizes microtubules, arresting mitosis. Targets: EGFR-overexpressing tumor cells and the EGFR signaling pathway, DNA replication/synthesis and mitotic machinery via chemotherapy.