A Prospective, Single-arm, Multicenter, Phase II Clinical Study on Envafolimab Combined With Disitamab Vedotin And Carboplatin for Resectable, Stage II-III, HER2-Mutant Non-Small Cell Lung Cancer
This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Envafolimab injection (PD-L1) combined with Disitamab Vedotin (HER2 ADC) and Carboplatin for resectable, HER2-Mutant, stage II-IIIB, NSCLC.
• Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
• Aged 18-75 years, male or female;
• Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; N2 should be confirmed by mediastinoscopy or EBUS.
• PET-CT or CT plus MRI should be completed before enrollment;
• HER2 mutations identified by histological specimens;
• Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);
• Tumor tissue specimens and blood sample available for detection of MRD and biomarkers (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment);
• ECOG score 0-1;
• No contraindications to immunotherapy;
⁃ Adequate organ function:
⁃ Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;
⁃ Pulmonary function being able to withstand the planned surgery evaluated by surgeons;
⁃ Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug