Efficacy and Safety of Osimertinib Adjuvant Therapy in High-risk Stage I EGFRm NSCLC After Complete Resection(OSTAR): a Prospective, Single-arm Study
This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).
• The subject will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
• Male and female, ≥18 years old;
• Primary non-squamous NSCLC confirmed histologically by the central laboratory;
• Brain imaging examinations should be performed before surgery or enrollment;
• The patient was clinically confirmed as stage I by imaging, and was staged according to the eighth edition of TNM lung cancer;
• As confirmed by the central laboratory, the tumor contains one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M;
• The primary NSCLC must be completely resected by surgery, and all lesions must be removed at the end of the surgery.All surgical margins must be negative. Lobectomy can be done with open surgery or thoracoscopic (VATS);
• Central laboratory pathology confirmed solid and/or micropapillary component ≥10%, or STAS;
• The interval from operation to adjuvant Osimertinib treatment is no more than 10 weeks;
⁃ WHO physical status score is 0\
• 1;
⁃ Paraffin-embedded sections (10-15 sheets), or wax blocks or fresh frozen tissue for surgical resection of the lesion should be provided;
⁃ At least 2 weeks prior to initiation of the study drug, female subjects should be using highly effective contraceptive methods, pregnancy tests must be negative, and there must be no ongoing breastfeeding prior to initiation of the drug, or else one of the following criteria must be met at the time of screening to demonstrate the possibility of non-fertility:
∙ Postmenopausal was defined as over 50 years of age and amenorrhea for at least 12 months after cessation of all exogenous hormone therapy.
‣ Women under 50 should be considered to have stopped menstruating if they have stopped menstruating for 12 months or more after stopping exogenous hormone therapy and their LH and FSH levels are within the agency's postmenopausal range.
⁃ Irreversible surgical sterilization recorded by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation;Male subjects must be willing to use barrier contraception.