Study design and patients
NSCLC, pneumonitis, infection disease, hepatitis B, extensive bowel resection, ILD, lung disease, cancer, non-melanoma skin cancer, human immunodeficiency virus, hypokalemia
RECURRENCE, CARCINOMA IN SITU, HEART, SUPERFICIAL BLADDER CANCER, CANCER, RECURRENT CANCER, COMPLETE LEFT BUNDLE BRANCH BLOCK, INTERSTITIAL LUNG DISEASE, HEPATITIS B, LUNG DISEASE, GASTROINTESTINAL DISEASE, BRAIN METASTASES, MINOR, MENINGEAL METASTASES, HEPATITIS C, PNEUMONITIS, HUMAN IMMUNODEFICIENCY VIRUS, CARCINOMA IN SITU OF CERVIX, LONG QT SYNDROME, SPINAL CORD COMPRESSION, GASTROINTESTINAL PERFORATION, NSCLC
This was a multicenter, single-arm, open-label, phase IIa study, which was part of the phase I/IIa study (NCT03386955), conducted across 20 hospitals in the People’s Republic of China. Key inclusion criteria included patients aged 18–75 years; with a histologically or cytologically confirmed locally advanced or metastatic NSCLC harboring Key exclusion criteria included patients who received previous anticancer treatment for advanced NSCLC including EGFR TKIs, cytotoxic chemotherapy, and investigational agent; any clinically significant electrocardiogram (ECG) abnormality (such as QTcF prolongation > 470 ms at rest, complete left bundle branch block); any factor that increased the risk of QTcF prolongation (such as New York Heart Association II-IV, hypokalemia, long QT syndrome); any condition that possibly affected drug absorption such as severe or uncontrolled inflammatory gastrointestinal disease, abdominal colostomy, gastrointestinal perforation within 6 months, extensive bowel resection, or tube feeding patients; medical history of interstitial lung disease (ILD), radiation pneumonitis that required steroid treatment, and acute or progressive lung disease that could lead to ILD; active infection disease such as hepatitis B, hepatitis C, and human immunodeficiency virus, inactive hepatitis B was acceptable; major surgery within 4 weeks, minor operation within 2 weeks; radiotherapy with a wide field within 4 weeks, or radiotherapy within a limited field within 1 week before the first dose of rezivertinib; patients with any other concomitant cancer or recurrent cancer within 5 years, except radical operation of carcinoma in situ of cervix, non-melanoma skin cancer, noninvasive superficial bladder cancer, or radical operation of carcinoma in situ with no recurrence within 3 years; patients with spinal cord compression or meningeal metastases, symptomatic brain metastases, except asymptomatic brain metastases not requiring steroids and/or local therapy before this study, asymptomatic brain metastases after local therapy such as radiotherapy and steroids and/or antiepileptic therapy at least 7 days before the first dose of rezivertinib.Informed consent was obtained from every patient before enrollment. The study was done in accordance with the Declaration of Helsinki and approved by the institutional review board or independent ethics committee associated with each participating hospital.