lung cancer
Conditions
Interventions
Treatment group:Almonertinib and Anlotinib
Sponsors
Tianjin Medical University Cancer Institute&Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced or metastatic NSCLC confirmed by clinical histology, with tissue or blood gene testing showing EGFR-sensitive mutations (19del and L858R); 2. Previous treatment with adjuvant EGFR-TKI (third-generation) with documented disease progression and recovery from any treatment-related toxicities to Grade =1.5×10^9/L - Platelet count >=100×10^9/L - Hemoglobin >=90 g/L - White blood cell count >=3.0×10^9/L - Liver function: Total bilirubin =2 (+), 24-hour urine protein quantification must be =50%. 9. Ability to communicate effectively with the investigator and comply with study visits, treatment, laboratory tests, and other study-related requirements.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer (including small cell and mixed small cell and non-small cell lung cancer). 2. Patients with symptomatic brain metastases at the start of treatment. 3. Patients who have participated in an interventional oncology clinical trial either during first-line treatment or within the last 30 days before starting first-line treatment. 4. Patients with a history of tracheoesophageal fistula, gastrointestinal perforation or fistula, and intra-abdominal abscess within the 6 months prior to starting treatment. 5. Patients with severe cardiovascular diseases, including but not limited to the following conditions within the past 6 months before randomization: cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, and significant vascular diseases (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis); patients with unstable angina, New York Heart Association (NYHA) classification (Appendix IV) >= Class II heart failure; average resting corrected QT interval (QTc) >470 milliseconds; any clinically significant resting electrocardiographic rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree heart block, second-degree heart block, interval >250 milliseconds. Any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, electrolyte abnormalities (including: serum/plasma potassium =2.5 mL). 8. Unhealed wound, active gastrointestinal ulceration, or fractures (excluding healed old fractures). 9. Known or suspected allergy to Almonertinib, Anlotinib, and/or any other components of their formulations. 10. Pregnant or lactating women. 11. Women of childbearing potential or male subjects who are not willing to use effective contraception during the study and for 6 months after the last dose of study drug. 12. Any other conditions that, in the investigator's judgment, make the subject unsuitable for enrollment, in addition to the above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate(ORR);Disease control rate(DCR);Duration of Response(DOR);Safety; | — |
Countries
China
Contacts
Public ContactMeng Wang
Tianjin Medical University Cancer Institute&Hospital
Outcome results
None listed