Study design and participants
NSCLC, toxicity, allergy, ALK-positive NSCLC, infection
MINOR, ALLERGY, MALIGNANT TUMORS, INFECTION, INTERSTITIAL FIBROSIS, CONGESTIVE HEART FAILURE, NSCLC, EVENTS, INTERSTITIAL LUNG DISEASE, METASTASES
This was a multicenter, randomized, open-label, active-controlled phase III trial, which enrolled patients with advanced ALK-positive NSCLC in 44 centers in China from August 21, 2019 to July 13, 2020. This trial was designed and conducted in accordance with the Declaration of Helsinki, GCP and current regulations. The study protocol was approved by the ethics committee of the leading center, and the study was registered with ClinicalTrials.gov (NCT04009317). All participants provided informed consent before study enrollment.Inclusion criteria were: (1) age of 18–75 years; (2) ECOG PS score of 0–1; (3) life expectancy ≥12 weeks; (4) histologically or cytologically confirmed locally advanced or metastatic (stage IIIB–IV) NSCLC with ALK rearrangements; (5) no previous ALK inhibitors as systemic treatment for stage IIIB–IV NSCLC; (6) <2 lines of chemotherapy for stage IIIB–IV NSCLC; and (7) ≥1 measurable lesion(s) (other than brain lesions) in the screening period according to RECIST 1.1.Key exclusion criteria were: (1) other malignant tumors; (2) allergy to the components of envonalkib or crizotinib; (3) other anti-tumor drugs administered within 4 weeks before the first dose; (4) any major surgeries performed within 4 weeks before the first dose; (5) received curative radiotherapy or minor surgery within 2 weeks before the first dose; (6) acute toxicity caused by any previous treatment not recovered to grade ≤1; (7) active infection; (8) uncontrolled congestive heart failure; (9) widely distributed interstitial fibrosis or interstitial lung disease; (10) symptomatic metastases to the central nervous system; or (11) any events preventing oral drug administration.