Lung cancer
Conditions
Interventions
Group 1:Ensartinib hydrochloride capsule
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology; 2. Previous genetic testing indicates that there is no mutation target that can be treated by targeted drugs; 3. Patients who have progressed after standard chemotherapy (including anti-angiogenesis therapy) or immunotherapy, or who cannot tolerate/refuse first-line chemotherapy; 4. Aged 18 to 70 years; 5. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2; 6. Expected survival period >= 3 months; 7. Good organ function; 8. Patients with biopsy specimens confirmed to be RDAA positive; 9. Asymptomatic CNS metastases that do not require steroids or anticonvulsant treatment; symptomatic CNS metastases can be treated with radiotherapy first, and no progression after reexamination for >= 28 days can be included in the group; meningeal disease cannot be included in the group; 10. Patients must have RECIST1.1 standard measurable target lesions; 11. Drug-related toxic reactions other than alopecia should be alleviated to grade 2 or below (CTCAE 5.0 criteria); 12. Willing and able to comply with trial and follow-up procedures; 13. Be able to understand the nature of the trial and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have used any ALK inhibitor in the past; 2. Patients currently receiving other anti-tumor systemic therapy; 3. Malignant tumors other than lung cancer have occurred in the past 3 years (excluding cured basal cell tumor of the skin, early gastrointestinal [GI] tumor resected under endoscopy, and carcinoma in situ of the cervix); 4. Patients who participated in clinical trials of other investigational drugs within 4 weeks before the first administration of ensatinib; 5. Major surgery or immunotherapy within 4 weeks before the first dose; patients who received radiation therapy within 2 weeks before the first dose; 6. Have received stem cell transplantation or organ transplantation; 7. Have serious cardiovascular disease; 8. Suffering from swallowing dysfunction, active gastrointestinal disease or other diseases that significantly affect the absorption, distribution, metabolism and excretion of Ensatinib. 9. Active hepatitis B (serum HBV DNA >= 104 copies/ml [ie 20000IU/ml]), positive for hepatitis C virus antibody, positive for HIV antibody, and positive for Treponema pallidum antibody; 10. Past history of interstitial lung disease, history of drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease; 11. Females of childbearing age, pregnant or lactating females with positive serum pregnancy test 7 days before starting treatment, or male and female subjects who did not take effective contraceptive measures or plan to give birth during the entire treatment period and 3 months after the end of treatment; 12. Patients who are known to have allergic reactions to ensatinib or any excipients of ensatinib (microcrystalline cellulose, stearic acid, hydroxypropyl methylcellulose); 13. Patients who have used the following drugs within 14 days before the first dose or need to be combined with the following drugs during treatment: drugs that cause QTc prolongation and/or torsades de pointes risk; strong inhibitors or strong inducers of CYP3A; 14. Patients who are receiving warfarin or any other coumarin derivative anticoagulant; 15. Other severe, acute or chronic medical conditions, including uncontrolled diabetes or medical or mental illness or laboratory abnormalities, that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results, according to the investigator's opinion; 16. Other conditions deemed inappropriate by the investigator to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;time to disease progression;Duration of tumor remission;intracranial objective response rate;intracranial progression-free survival;time to intracranial progression;extracranial objective response rate;Extracranial progression-free survival;time to extracranial progression;overall survival;patient-reported time to exacerbation;health-related quality of life; | — |
Countries
China
Contacts
Public ContactLiu Lunxu
West China Hospital, Sichuan University
Outcome results
None listed