To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+/2+/3+)
Aged 18-75 years, male or female without restriction;
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1; Estimated survival time ≥ 3 months;
Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC);
At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);
Histologically confirmed tumor containing small cell lung cancer components.
Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid intervention, or any clinical evidence of active ILD.
Symptomatic or actively progressive central nervous system (CNS) metastases or leptomeningeal metastases confirmed by CT/MRI during screening and prior to radiological assessment.
Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days before the first study drug administration. 5. Nasal/inhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg prednisolone per day or equivalent physiological doses of other corticosteroids) are excluded from this restriction.
Yongsheng Wang
Lead sponsor
Sichuan University
Sponsor institution