lung cancer
Conditions
Interventions
Anrotinib, individualized selected dose 8/10/12 mg, QD.
Treatment until disease progression or intolerable toxicity, subject withdraws ICF (up to 2 years)
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age =18 years, regardless of gender; (2) Enrolled patients must qualify as non-small cell lung cancer patients with pre-existing recurrence or metastasis; (3) Progression after prior standard first-line systemic therapy; (4) Negative for all driver genes (EGFR, ALK, ROS-1, MET, RET). (5) Eastern Cooperative Oncology Group (ECOG) score of 0-3 and expected survival >3 months; (6) Have at least one measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1. 1); (7) No history of immunologic disease; (8) Basically normal hematological parameters: white blood cell count = 4 × 109/L; absolute neutrophil count = 1.5 × 109/L; platelets = 100 × 109/L; hemoglobin = 90 g/L; (9) Renal function is basically normal: serum creatinine = 1.2 mg/dL or creatinine clearance = 60 mL/min; (10) Substantially normal liver function: serum total bilirubin = 1.5 × ULN (= 3.0 × ULN if there are liver metastases); azelotransferase (AST) and alanine transaminase (ALT) = 2.5 × ULN (= 5.0 × ULN if there are liver metastases); (11) Female patients must have a negative urine pregnancy test prior to study entry (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients); (12) Signed written informed consent and be able to comply with the protocol during the study.
Exclusion criteria
Exclusion criteria: (1) The patient has any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; the patient has vitiligo; patients with asthma that has resolved completely in childhood and does not require any interventions in adulthood are eligible for inclusion; and patients who require bronchodilators for medical patients with asthma requiring medical intervention with bronchodilators could not be included) (2) Participation in another interventional clinical trial within 30 days prior to screening; (3) Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) and continue to do so within 2 weeks prior to enrollment; (4) Presence of poorly controlled co-morbidities (e.g., heart failure, diabetes mellitus, hypertension, coronary artery disease, thyroid disease, psychiatric disorders, etc.); (5) Known infectious diseases such as HIV infection or active viral hepatitis; (6) Imaging showing tumor invasion of surrounding vital organs and blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or the presence of significant necrosis or cavities that, in the judgment of the investigator, pose a risk of bleeding; (7) Individuals who are allergic to the drugs or their components used in this protocol; (8) Grade =2 peripheral neuropathy or hearing loss according to the criteria of the Common Terminology for Adverse Events (NCI CTCAE V5.0); (9) Pregnant (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing potential who are unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment; (10) Those who do not wish to participate in this study or are unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;9/12-month OS rate;DCR;QoL;safety; | — |
Countries
CHINA
Contacts
Public ContactJianfeng Huang
Affiliated Hospital of Jiangnan University
Outcome results
None listed