Actively Recruiting
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance
Led by Qianfoshan Hospital · Updated on 2023-09-21
98
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation. This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0). Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
CONDITIONS
Official Title
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic non-squamous NSCLC proven by histology or cytology and not suitable for surgery or radical concurrent chemoradiotherapy, stage IIIa-IIIB according to standard staging
- Patients with advanced non-squamous NSCLC having EGFR mutation and TP53 mutation
- Patients who have not received systemic chemotherapy or radiotherapy before, or relapsed after more than 6 months following adjuvant chemotherapy
- At least one measurable tumor lesion as per RECIST criteria
- Male or female patients aged 18 to 75 years
- Performance status score 0-1 based on Eastern Cooperative Oncology Group (ECOG)
- Expected survival time of 12 weeks or more
- Adequate blood counts: neutrophils 1.5 x 10^9/L, platelets 100 x 10^9/L, hemoglobin 90 g/L
- Liver function tests within specified limits: bilirubin 1.5 times upper limit of normal (ULN), AST and ALT 2.5 times ULN, alkaline phosphatase 5 times ULN
- Kidney function: creatinine ULN or creatinine clearance 60 mL/min
- More than 4 weeks recovered from any prior surgery
- Women with intact uterus must have a negative pregnancy test within 28 days before enrollment or meet amenorrhea criteria
- Patients at risk of pregnancy must use effective contraception during treatment and for 120 days after last dose
- Signed informed consent with good compliance
You will not qualify if you...
- Known allergy or intolerance to almonertinib, anlotinib, or their components
- Pregnancy or breastfeeding, or unwillingness to use contraception if at risk of pregnancy
- Uncontrolled or severe infections including acute, suppurative, or chronic infections
- Serious pre-existing heart conditions such as congestive heart failure, unstable angina, recent myocardial infarction, severe valvular disease, or refractory hypertension
- Uncontrolled neuropsychiatric disorders or mental illnesses impairing cooperation
- Unmanageable primary brain tumor or central nervous system metastases with severe symptoms
- Hereditary bleeding disorders, coagulation dysfunction, history of thrombosis or bleeding, or abnormal coagulation tests
- Receiving thrombolytic or anticoagulant therapy for high thrombosis risk
- Unhealed wounds, ulcers, or fractures
- Participation in other clinical trials or use of investigational drugs/devices within 4 weeks prior to study
- Major surgery within 4 weeks before treatment or planned during the study period (except minor procedures)
- Pulmonary interstitial fibrosis or COPD with respiratory failure
- Active tuberculosis or autoimmune disease requiring systemic treatment within 2 years
- Use of systemic glucocorticoids or immunosuppressants within 14 days before treatment start (excluding local nasal or inhaled steroids)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Degan Lu
Jinan, Shandong, China, 250014
Actively Recruiting
Research Team
D
Degan Lu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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