Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer

Soochow University

Status

Unknown

Conditions

Non-Small-Cell Lung

Treatments

Drug: Anlotinib Hydrochloride

Drug: Icotinib

Drug: Gefitinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03766490

ALTER-L010

Details and patient eligibility

About

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 bevacizumab combined with EGFR TKI have a good trend of benefit. This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer . The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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