Non-small cell Lung Cancer
Conditions
Interventions
Experimental group:Osimertinib Plus Anlotinib
Sponsors
Dongguan People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Aged 18 to 75 years, male and female; 2)ECOG status score 0-2 points; 3)the expected life is not less than 12 weeks; 4) Pathologically confirmed stage IV non-small cell lung cancer with measurable lesions (tumour lesions =10mm long on CT scan and lymph node lesions =15mm short on CT scan according to RECIST 1.1 criteria, measurable lesions have not received local treatment such as radiotherapy or cryotherapy) 5) NSCLC Patients presenting with an EGFR activating mutation (19del or 21 L858R or T790M) according to any validated method and containing one or more of TP53, PIK3CA, KRAS, MYC, RB1 by NGS sequencing. 6)No previous chemotherapy or other targeted therapy; 7) Patients who have received previous radiotherapy may be enrolled, but the area radiated must be <25% of the bone marrow area (Cristy and Eckerman 1987) and no total pelvic or thoracic irradiation has been used; previous radiotherapy must have been completed for at least 4 weeks at study entry and acute toxic effects from previous radiotherapy must have recovered; localized lesions treated with radiotherapy cannot be included in measurable lesions unless significant progression of the lesion has been documented after the last radiotherapy session. 8) Normal function of major organs, i.e. meeting the following criteria. a)Routine blood tests must meet the following criteria: ANC = 1.5 x 109/L; PLT = 100 x 109/L; Hb = 100 g/L; (no transfusion of blood and blood products within 14 days, no correction with G-CSF and other haematopoietic stimulating factors) b)Biochemical tests are required to meet the following criteria: TBIL < 1.5 x ULN; ALT and AST < 2.5 x ULN, and for patients with liver metastases, ALT and AST < 5 x ULN; BUN and Cr = 1 x ULN or endogenous creatinine clearance = 50 ml/min (Cockcroft-Gault formula). 9)Women of reproductive age must be using reliable contraception or have had a negative pregnancy test (serum or urine) within 7 days prior to enrolment and be willing to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the last dose of the test drug. For men, consent to use an appropriate method of contraception or to have been surgically sterilised during the trial and 8 weeks after the last dose of the test drug. 10)Voluntary into group and sign the informed consent, follow the test treatment plan and visit plan.
Exclusion criteria
Exclusion criteria: 1) small cell lung cancer (including small cell carcinoma and mixed non-small cell lung cancer). 2) Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days prior to enrolment and are symptomatically stable may be enrolled, provided they are confirmed as symptom-free for brain haemorrhage by cranial MRI, CT or venography evaluation); 3) The presence of a centrally located tumour that invades a localised large vessel; or shows the presence of an apparently cavernous or necrotic tumour in the lung; or where the investigator assesses that the tumour lesion is at risk of bleeding in close proximity to a large vessel, based on imaging (CT or MRI); 4) The presence of only EGFR activating mutations(19del or 21 L858R or T790M) by NGS sequencing; 5) Patients with hypertension who are being treated with a combination of two or more antihypertensive drugs; 6) Hemoptysis of two teaspoons or more per day prior to entry; 7) urine routine suggestive of urine protein = ++ and confirmed 24-hour urine protein amount = 1.0 g; 8) Patients with a history of interstitial lung disease or concurrent interstitial lung disease. 9) abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendencies or on thrombolytic or anticoagulant therapy; 10) Clinically significant bleeding symptoms or a definite bleeding tendency within 3 months prior to enrolment, e.g. peptic bleeding, bleeding haemorrhoids, bleeding gastric ulcer, fecal occult blood +++ or above at baseline, or vasculitis; 11) Heritable or acquired bleeding and thrombotic tendencies known to exist (e.g. haemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 12) Long-standing untreated wounds or fractures(pathological fractures due to tumours do not count); 13) Major surgical procedure or severe traumatic injury, fracture or ulcer within 4 weeks of admissio; 14) Significant factors affecting the absorption of oral medication, such as inability to swallow, chronic diarrhoea and intestinal obstruction; 15) Abdominal fistula, gastrointestinal perforation or abdominal abscess in the 6 months prior to enrolment. 16) Plasma cavity effusions (including pleural,ascites and pericardial effusions) that have clinical symptoms and require symptomatic management; Note: Patients with asymptomatic plasmacytosis can be enrolled. Patients with symptomatic plasmacytosis who have undergone active symptomatic management (no anti-cancer drugs for plasmacytosis) and are judged by the investigator to be eligible for enrollment are allowed to be enrolled; 17) Those with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder; 18) who have participated in a clinical trial of another antineoplastic drug within 4 weeks prior to enrolment; 19) Previous or concurrent other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer. 20) Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception; 21) other circumstances that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS) rate at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| median overall survival(mOS);median progression-free survival(mPFS);disease control rate(DCR);objective response rate(ORR); | — |
Countries
China
Contacts
Public ContactGuanMing Jiang
Dongguan People’s Hospita
Outcome results
None listed