Advanced non-squamous non-small cell lung cancer
Conditions
Interventions
Osimertinib + anlotinib group:Osimertinib + anlotinib
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Greater than or equal to 18 years old, male or female; 2. ECOG score 0-1 during screening; 3. Life expectancy >= 3 months; 4. Non-squamous non-small cell lung cancer (NSCLC) with stage IV or recurrent EGFR sensitive gene mutation (Exon19del or Exon21 L858R point mutation) and TP53 mutation confirmed by histopathology or cytopathology; 5. No previous palliative chemotherapy, palliative biological therapy (including targeted therapy, such as EGFR or VEGF inhibitors) or immunotherapy. Previous adjuvant chemotherapy is allowed to be included, but the end of adjuvant chemotherapy is required to be more than 6 months from the start of study treatment. . Palliative radiotherapy for metastatic lesions is allowed, but palliative radiotherapy for large lung fields must be completed at least 4 weeks before the start of study treatment and there are no persistent radiotherapy-related toxicities; 6. The subject has sufficient organ function:Adequate bone marrow reserve: absolute neutrophil (segmental and band) (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Hemoglobin (HGB) >=90g/L; Granulocyte colony-stimulating factor support, platelet transfusion, and transfusion to meet these criteria are not allowed; Hepatic: serum total bilirubin (TBIL) =50 ml/min; 7. Female subjects must use highly effective contraceptive measures. If they are of childbearing age, the pregnancy test result must be negative before starting medication; or they must meet one of the following criteria during screening to prove that they are sterile: 8. Postmenopausal, defined as age >=50 years and amenorrhea for at least 12 months after stopping all exogenous hormone therapy; 9.Signed informed consent prior to any specific study procedures.
Exclusion criteria
Exclusion criteria: Patients with any of the following cannot be enrolled in this study: . Personnel involved in the planning and/or execution of the study (applicable to investigators and/or research center staff); . Previously enrolled in this study or previously received osimertin ; . Known severe allergy to any component of osimertinib or anlotinib; . Past or current history of other malignant tumors, except basal cell carcinoma of the skin and carcinoma in situ of the cervix; . Have a history of interstitial lung disease requiring steroid therapy, drug-induced interstitial disease, radiation pneumonitis, or any evidence of active interstitial lung disease; . Meet any of the following cardiac criteria: - 3 electrocardiograms ( ECG) examination showed mean resting corrected QT interval (QTc) >470 ms (QTc value obtained using clinical screening ECG machine) - Any clinically important abnormality in heart rhythm, conduction, or resting ECG morphology, such as complete left bundle branch block, third-degree heart block, and second-degree heart block. Patients with any factors that increase the risk of QTc interval prolongation or arrhythmic events, such as heart failure, electrolyte abnormalities (including: serum/plasma potassium <LLN, serum/plasma magnesium <LLN and serum/plasma calcium <LLN), congenital long QT syndrome , family history of long QT syndrome or unexplained sudden death of a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval and cause torsade de pointes* Electrolyte abnormalities can be corrected to normal during screening within the range. . Presence of CT scan-confirmed idiopathic pulmonary interstitial fibrosis at baseline; . Any unresolved chronic toxicity of CTCAE grade 2 or above after previous antineoplastic treatment; . Any serious or uncontrolled systemic disease as determined by the investigator ( Such as unstable or decompensated respiratory system/cardiovascular system/hepatic and renal disease); . Any other obvious abnormal clinical manifestations or abnormal laboratory tests that prevent the patient from participating in clinical research; . Pregnancy or lactation; . The investigator determined that the patient was unable to tolerate the osimertinib combined with anlotinib regimen; . Life expectancy <=12 weeks; . Use of unapproved drugs or investigational drugs within 30 days before the start of the study; . Symptomatic brain metastasis; . Any Evidence of severe and uncontrolled systemic disease, including uncontrolled hypertension and active bleeding diabetics (who, in the opinion of the investigator, should not participate in the trial or who may interfere with the protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhao Yanqiu
Henan Cancer Hospital
Outcome results
None listed