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

NCT03766490 | Unknown

• 1 other identifier: ALTER-L010
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• PFS（Progress free survival）

  PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

  each 42 days up to PD or death(up to 24 months)

Secondary Outcomes (4)

• Overall Survival (OS)

  From randomization until death (up to 24 months)

• Objective Response Rate (ORR)

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Quality of Life(QoL)

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Disease Control Rate (DCR)

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

Anlotinib Hydrochloride plus gefitinib or icotinib

EXPERIMENTAL

Drug: Anlotinib Hydrochloride; Drug: Gefitinib; Drug: Icotinib

Interventions

Anlotinib Hydrochloride DRUG

Capsule, P.O. 12mg qd ,days 1-14, 21 days a cycle

Anlotinib Hydrochloride plus gefitinib or icotinib

Gefitinib DRUG

Tablet, P.O. 250mg qd

Anlotinib Hydrochloride plus gefitinib or icotinib

Icotinib DRUG

Tablet, P.O. 125mg tid

Anlotinib Hydrochloride plus gefitinib or icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The First People's Hospital of Changzhou: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Nantong University: collaborator
• Affiliated Hospital of Jiangnan University: collaborator
• Jiangyin People's Hospital: collaborator
• Changzhou No.2 People's Hospital: collaborator
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated hospital of soochow university

Suzhou, Jangsu, China

Location

MeSH Terms

Interventions

Gefitinib; icotinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Min Tao, Doctor

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Tao, Doctor

CONTACT

008613962125300; taomin@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Anlotinib Hydrochloride Combined With gefitinib or Icotinib

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 6, 2018
• Study Start: March 30, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2020
• Last Updated: January 30, 2019

Record last verified: 2018-12

Locations

CN (1)