Study design and patients
NSCLC, Tumor, Tumors, tumors, hemoptysis
COAGULATION DISORDER, UNCONTROLLED HYPERTENSION, TUMOR, BRAIN METASTASES, DISEASE, TUMORS, NSCLC, DELETION, ONCOLOGY, TUMORS
This phase2, single-arm, multicentre trial (ClinicalTrials.gov NCT03736837) was conducted at five research centers in China between December 2018 and November 2020. This study was approved by the independent institutional review boards or independent ethics committees associated with each participating center. All patients provided written informed consent before enrollment. Eligible patients had histologically or cytologically confirmed stage IIIB/IV or postoperative recurrent non-squamous NSCLC with EGFR-sensitizing mutations (exon 19 deletion or Leu858Arg mutation). Tumor samples were screened for EGFR mutations by NGS certified by CLIA or CAP. Patients aged 18–75 years with one or more measurable lesion(s) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. No previous chemotherapy or EGFR-TKIs for advanced disease was allowed, including neoadjuvant or adjuvant chemotherapy in the previous 6 months from the final administration date. Other inclusion criteria included Eastern Cooperative Oncology Group performance status 0 or 1; adequate hematological, hepatic, and renal functions; asymptomatic or mildly symptomatic brain metastases; and life expectancy ≥ 3 months at the time of enrollment.Major exclusion criteria included confirmation of history or presence of hemoptysis or bloody sputum, any coagulation disorder, severe or uncontrolled hypertension, or tumors invading or abutting major blood vessels.