eligibility_summary
Eligible: adults 18-74 with untreated advanced/metastatic non-squamous NSCLC, EGFR/BRAF/ALK/ROS negative, CEACAM5 IHC >=2+ in >=1% tumor, adequate organ function, life expectancy >3 mo, consent. Exclude: mixed SCLC/squamous, unstable brain metastases/leptomeningeal disease, serious illness, recent other invasive cancers, HIV/AIDS needing ART, active hepatitis A/B/C, active autoimmune needing systemic therapy, unresolved >=Grade 2 toxicity (exceptions), corneal disease/contact lenses, recent TCM/immunomodulators, prior systemic therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label study in CEACAM5-positive advanced/metastatic non-squamous NSCLC (first line). Arms: (1) tusamitamab ravtansine (IBI126) + sintilimab, (2) tusamitamab ravtansine + sintilimab + carboplatin/cisplatin + pemetrexed, comparator: sintilimab + platinum + pemetrexed. Drug types/mechanisms: Tusamitamab ravtansine is an antibody–drug conjugate (ADC) targeting CEACAM5, upon binding/internalization it releases DM4 (ravtansine), a maytansinoid microtubule inhibitor causing mitotic arrest/cell death. Sintilimab is an anti–PD-1 IgG4 monoclonal antibody that restores T-cell antitumor immunity. Carboplatin/cisplatin are DNA-crosslinking cytotoxics. Pemetrexed is an antifolate inhibiting thymidylate synthase and related enzymes. Targets/pathways: CEACAM5+ tumor cells, PD-1/PD-L1 immune checkpoint on T cells, DNA damage pathways, and folate-dependent nucleotide synthesis.