Actively Recruiting
A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation
Led by Kunming Medical University · Updated on 2023-10-26
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, multicenter, single arm clinical study. Thirty subjects who will have been diagnosed with locally advanced or metastatic non-small cell lung cancer with EGFR 21L858R mutation detected in lung cancer tissue or peripheral blood will be recruited and treated with anlotinib and aumolertinib. The efficacy will be evaluated according to the Solid Tumor Efficacy Evaluation Standard (RECIST 1.1), and evaluated every 6 to 8 weeks. The survival status and adverse reactions of the subjects will be recorded. The study will be terminated when the subjects experience disease progression or intolerable drug toxicity, or the subjects withdraw their informed consent. The main purpose of the study is to observe the efficacy and safety of the combined treatment regimen in such subjects. The primary endpoint of the study is median progression free survival (mPFS); The secondary study endpoints are objective response rate (ORR), disease control rate (DCR), median overall survival time (mOS), and safety.
CONDITIONS
Official Title
A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years who voluntarily consent to participate
- Diagnosed with locally advanced unresectable or metastatic NSCLC (stage IIIB, IIIC, or IV) confirmed by tissue or cytology
- Presence of EGFR 21 exon L858R mutation
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 3
- Expected survival longer than 3 months
- No prior systemic anti-cancer treatment including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- Adequate organ function within 7 days before treatment including hemoglobin ≥90g/L, neutrophils ≥1.5 × 10⁹/L, platelets ≥80 × 10⁹/L
- Liver function: total bilirubin ≤1.5 times upper limit of normal (ULN), ALT and AST ≤2.5 ULN (or ≤5 ULN if liver metastasis present)
- Kidney function: serum creatinine ≤1.5 ULN or creatinine clearance ≥60 ml/min
You will not qualify if you...
- Presence of mixed NSCLC with other pathological types
- Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Tumor invasion into major blood vessels or high risk of fatal bleeding
- History of arterial or venous thrombosis (e.g., stroke, deep vein thrombosis, pulmonary embolism) within past 6 months
- Conditions affecting ability to take oral medication such as swallowing difficulty, gastrointestinal surgery, chronic diarrhea, or intestinal obstruction
- Symptomatic brain metastases
- Severe or uncontrolled heart diseases within 6 months such as myocardial infarction, unstable angina, heart failure, or arrhythmias
- Active or uncontrolled severe infections
- Severe liver dysfunction, cirrhosis, or active hepatitis
- Significant proteinuria in urine tests
- Active pulmonary tuberculosis
- Pregnancy or breastfeeding
- Any other serious illness, mental health condition, or social factors that could affect safety or study compliance as judged by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Kunming University
Kunming, Yunnan, China
Actively Recruiting
Research Team
J
Jianqing Zhang, Ph.D
CONTACT
J
Jiagang Feng
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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