NSCLC
Conditions
Interventions
Adjuvant targeted therapy:Ensartinib
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed diagnosis of stage II-IIIB lung adenocarcinoma after complete surgical resection. 2.ALK fusion positive 3.18=age=75 4.ECOG PS 0-2 5.Complete recovery from surgery and standard adjuvant chemotherapy at the time of randomization. Patients must have recovered from all toxicity>CTCAE garde 1 caused by previous treatment when they start to be given the study drug, except for alopecia and grade 2 platinum-associated neuropathy. 6.Organ function must meet the following criteria: 1)Bone marrow: ANC =1.5 × 109/L, PLT=100 × 109/L, Hb=9 g /dl. 2)Liver: TBil=2 ULN, AST and ALT=2.5 ULN. 3)Kidney: Cre=1.5 ULN or Ccr=60 ml/min. 4)No malabsorption or other gastrointestinal diseases that may impact drug absorption. 7.For female patients of childbearing age, pregnancy test must be conducted within 7 days before treatment starts, and the result must be negative.For male patients of childbearing age, either sterilization surgery or using adequate contraceptive measures during treatment and for 3 months after its completion is needed. 8.Patients could understand and volunteer to sign the informed consent file.
Exclusion criteria
Exclusion criteria: 1.Prior treatment with ALK-TKI at any time (including neoadjuvant therapy). 2.Any of the following diseases or conditions: 1)Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroids treatment, or any evidence of clinically active ILD. 2)ILD diagnosed by baseline CT scan. 3)Any evidence of severe or uncontrolled systemic diseases (including unstable or decompenstated respiratory/cardiac/liver/kidney diseases) according to the researchers judgment. 4)Any unstable systemic disease (including active infection, grade 3 hypertension, unstable angina, congestive heart failure, liver/kidney diseases or metabolic diseases). 5)Clear medical history of neurological or psychiatric disorders (including dementia and epilepsy). 3.Pregnant and breast-feeding women. 4.Subjects who are possibly unable to complete the research or follow regulations of the research (due to management issues or other reasons) judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year DFS rate;5-year OS rate;Safety;DFS; | — |
Countries
China
Contacts
Public ContactJunling Li
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed