locally advanced or metastatic non-small cell lung cancer with EGFR mutation positive
Conditions
Interventions
Treatment group:Suttinib maleate
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Aged 18 (including 18) years or above, gender is not limited. (2) Patients with locally advanced or metastatic NSCLC confirmed by histology and/or cytology. (3) There are positive EGFR sensitive mutations such as 19del, L858R, or rare mutations such as G719X, L861Q, S768I (tumor tissue biopsy or blood sample), and there can be compound mutations, but other second tumor driven mutations such as 20 exon insertion and KRAS are excluded. (4) At least one measurable lesion according to RECIST1.1. (5) The Eastern Collaborative Oncology Group (ECOG) Performance score was 0-2. (6) Expected survival time >3 months. (7) Adequate bone marrow, liver, kidney and coagulation function (no blood transfusion or blood products, no granulocyte colony-stimulating factor or other hematopoietic stimulatory factors were used to correct the study drug within 2 weeks before the first administration) : Bone marrow: absolute neutrophil count =1.5×109/L, platelet count =90×109/L, hemoglobin =90g/L; Liver: total bilirubin (TBIL) =1.5× upper limit of normal value (ULN), alanine aminotransferase (ALT) =2.5×ULN, aspartate aminotransferase (AST) =2.5×ULN (TBIL=3.0×ULN, ALT=5.0×ULN, AST=5.0×ULN); Kidney: creatinine clearance rate =50mL/min (calculated by Cockcroft-Gault formula); Blood coagulation: International normalized ratio (INR) =1.5 (8) Fertile eligible subjects (male and female) must consent to use a reliable method of contraception (hormonal or barrier methods or abstinence) during the trial and for at least 6 months after the last dose; Female subjects of childbearing age must have negative pregnancy examination before inclusion. Male subjects were not allowed to donate sperm from the first dose to 6 months after the last dose. (9) All subjects must be aware of the study prior to any test required by the trial, voluntarily sign a written informed consent (ICF) approved by the ethics committee, and be willing to follow the trial treatment protocol and visit plan.
Exclusion criteria
Exclusion criteria: (1) Received any epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) anti-tumor therapy before enrollment. (2) Received systemic antitumor therapy such as chemotherapy and immunotherapy within 4 weeks before enrollment; Within 2 weeks before enrollment, she received palliative radiotherapy for non-target lesions with the purpose of alleviating symptoms, and traditional Chinese medicine (including proprietary Chinese medicine) with tumor as the indication. (3) Had used drugs or foods that strongly inhibited or induced cytochrome P450 (CYP) isoenzyme CYP3A4 within 7 days before enrollment or within 5 half-lives (whichever was longer). (4) had undergone major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks before enrollment. Note: Significant trauma was defined as severity of grade 3 or higher in each subcategory under the National Cancer Institut-Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) "Trauma, Poisoning, and surgical complications." (5) At the time of screening, adverse reactions of any previous treatment had not recovered to NCI CTCAEv5.0 severity evaluation = grade 1 (except alopecia). (6) Inability to take oral medication, severe (NCI CTCAE v5.0 severity =3) chronic gastrointestinal dysfunction, malabsorption syndrome, or any other condition affecting gastrointestinal absorption. (7) There were spinal cord compression, symptomatic, unstable brain metastasis and meningeal metastasis; However, patients with brain metastasis who are stable for at least 2 weeks after complete treatment or steroid treatment can be included in the group. (8) Previous or current interstitial lung disease, radiation pneumonitis requiring hormone therapy, or drug-associated pneumonitis, and the presence of idiopathic interstitial pulmonary fibrosis on CT scan at baseline; Patients with unstable pleural effusion or abdominal effusion with obvious symptoms, or those whose clinical symptoms were not stable for 21 days after treatment with pleural effusion or ascites, were judged to be ineligible to participate in the trial. (9) At the time of screening, there was an uncontrolled active infection [e.g., active tuberculosis infection, need for intravenous antibiotic treatment, syphilis, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection]. Note: Subjects were eligible if they were HBsAg positive, HBV-DNA480 msec (calculated according to Fridericia's formula). (11) had a history of other severe (NCI CTCAE v5.0 severity =3) systemic disease and was deemed ineligible for trial participation by the investigator. (12) Participated in other interventional clinical trials within 4 weeks before enrollment, or less than 5 half-lives since the last use of the trial drug. (13) Known alcohol or drug dependence. (14) A definite history of neurological or psychiatric disorders (including epilepsy or dementia), current psychiatric disorders, or poor investigator compliance was deem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;1-year progression-free survival;1-year survival rate;Overall survival;Duration of Response;Time to progression;Time to treatment failure;Time to Response; | — |
Countries
China
Contacts
Public ContactWu Fengying
Shanghai Pulmonary Hospital
Outcome results
None listed