Actively Recruiting
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation and TP53 Mutation
Led by Qianfoshan Hospital · Updated on 2023-09-21
98
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness and safety of combining almonertinib with anlotinib as the first treatment for adults with advanced non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR and TP53 genes. This single-arm, exploratory study focuses on patients with non-squamous NSCLC who have not received prior systemic therapy or have relapsed after adjuvant chemotherapy. The study aims to measure progression-free survival (PFS) as the main outcome, along with overall survival (OS), objective response rate (ORR), and safety as secondary outcomes. Participants receive almonertinib at a dose of 110 mg daily and anlotinib at 12 mg daily, starting on the first day of each treatment cycle. Treatment cycles last three weeks, with anlotinib taken for two weeks followed by one week off. This regimen continues until the disease progresses or side effects become intolerable. The study includes regular assessments of disease status at baseline, 6 weeks, 12 weeks, and every 9 weeks thereafter using RECIST 1.1 criteria. During the study, participants undergo evaluations to monitor tumor response, safety, and side effects, following NCI CTCAE version 4.0. Safety is closely tracked, especially when adverse events occur, and patients are followed until these events resolve. After stopping treatment, survival status is checked every three months until death. Statistical methods like the Kaplan-Meier curve are used to analyze progression-free and overall survival, while descriptive statistics assess response rates and disease control.
CONDITIONS
Brief 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...
- Histologically or cytologically confirmed metastatic non-squamous NSCLC that is inoperable and unsuitable for radical concurrent chemoradiotherapy
- Diagnosed with EGFR mutation and TP53 mutation advanced non-squamous NSCLC
- No prior systemic radiotherapy or chemotherapy within 6 months after adjuvant chemotherapy relapse
- At least one measurable lesion based on RECIST criteria
- Male or female aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate blood counts: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L
- Liver function within specified limits: bilirubin ≤ 1.5 times ULN, AST and ALT ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN
- Kidney function: serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min
- Recovery of more than 4 weeks from any prior surgery
- Negative pregnancy test within 28 days before enrollment for women with an intact uterus
- Use of effective contraception during treatment and for 120 days after last dose
- Signed informed consent with good compliance
You will not qualify if you...
- Allergy or intolerance to almonertinib, anlotinib, or their components
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Uncontrolled severe acute or chronic infections
- Serious heart diseases such as congestive heart failure, unstable angina, or severe arrhythmias
- Uncontrollable neuropsychiatric disorders or inability to cooperate
- Presence of primary brain tumor or uncontrolled brain metastases with severe symptoms
- Bleeding disorders, history of thrombosis, or abnormal coagulation tests
- Use of thrombolytic or anticoagulant therapy due to high thrombosis risk
- Unhealed wounds, ulcers, or fractures
- Participation in other interventional clinical trials or recent investigational treatments within 4 weeks
- Major surgery within 4 weeks before study start or planned major surgery during the study
- Pulmonary fibrosis or chronic obstructive pulmonary disease with respiratory failure
- Active tuberculosis or autoimmune disease requiring systemic therapy within 2 years
- Recent systemic glucocorticoid or immunosuppressive therapy within 14 days before treatment start
- Any other condition deemed inappropriate for trial participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months or until disease progression or intolerable toxicity
Participants receive almonertinib daily and anlotinib in cycles of two weeks on treatment followed by one week off. Treatment cycles repeat every three weeks until disease progression or intolerable toxicity.
Visits for disease assessment at baseline, 6 weeks, 12 weeks, and every 9 weeks thereafter during treatment
Duration - Until death
After discontinuing treatment, participants are followed every 3 months to monitor survival status until death.
Quarterly follow-up visits
Trial Site Locations
Total: 1 location
1
Degan Lu
Jinan, Shandong, China, 250014
Actively Recruiting
Research Team
D
Degan Lu, Professor
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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