Status:
UNKNOWN
Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
The First People's Hospital of Changzhou
Second Affiliated Hospital of Soochow University
Conditions:
Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizu...
Eligibility Criteria
Inclusion
- Participants must have histlogically confirmed stage IV non-small cell lung cancer .
- The initial treatment with gefitinib/icotinib evaluated PR/NC and the efficacy lasted for more than 6 months, then the disease progressed later. (The efficacy was assessed as PD according to the evaluation standard of RECIST1.1)
- At least a measurable lesion that meets the RECIST 1.1 criteria.
- Any gender. Age ≥18 years and ≤75 years
- Life expectancy \>3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment.
- Adequate organ function: haemoglobin ≥ 90 g/L;neutrophils count ≥1.5×109/L; platelet count ≥ 90 × 109/L; total bilirubin ≤ 1.5 × ULN ;ALT \< 2 × ULN, (ALT \< 5 × ULN, for those with liver metastases);AST \< 2 × ULN, (AST \< 5 × ULN, for those with liver metastases); Cr≤1.5× ULN.
- Echocardiography : LVEF≥50%
- 12-leads electrocardiogram : QTcF\<450ms (man), \<470ms(woman)
- Patient informed consent and signed written consent
- Patient compliance was good and voluntary follow-up, treatment, laboratory testing, and other research steps were performed as planned.
Exclusion
- The patient has previously received anti-tumor therapy for EGFR TKIs other than gefitinib and ectinib for lung cancer.
- Patients that cannot detect EGFR gene, or patients with known T790M mutation.
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer).
- CT or MRI shows that the tumor lesion is ≤ 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor.
- Active brain metastasis, cancerous meningitis, spinal cord compression patients.
- Other active malignancies that require simultaneous treatment.
- Has a history of malignant tumors in the past 5 years.
- Patients with previous anti-tumor treatment-related adverse reactions who have not recovered to NCI-CTC AE≤1.
- Abnormal coagulation ,with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
- Renal insufficiency: urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g, or creatinine clearance \<60ml / min.
- Severe acute or chronic infection requiring systemic treatment.
- Suffering from severe cardiovascular disease: myocardial ischemia ,myocardial or arrhythmia.
- Clinically significant hemoptysis occurred within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or a clear tendency to hemorrhage.
- Untreated active hepatitis : Hepatitis B or Hepatitis C
Key Trial Info
Start Date :
March 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03766490
Start Date
March 30 2019
End Date
December 20 2020
Last Update
January 30 2019
Active Locations (1)
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1
The First Affiliated hospital of soochow university
Suzhou, Jangsu, China