Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation

NCT03153358 | Unknown Phase 2

• 1 other identifier: EK2017001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Many patients with oncogene-driven non-small-cell lung cancer (NSCLC) treated with tyrosine kinase inhibitors experience limited sites of disease progression. For multiple metastases in patients with advanced NSCLC, increased local treatment may benefit to prolong patient survival. This study investigated the benefits of icotinib limited systemic disease progression and continuation of Stereotactic Body Radiation Therapy,in patients with metastatic EGFR-mutant NSCLC.

Conditions

Lung Cancer Stage IV

Keywords

EGFR mutation icotinib SBRT

Outcome Measures

Primary Outcomes (1)

• progression free survival

  the time to disease to progression according the RESCIT

  four weeks

Secondary Outcomes (1)

• object responsible rate

  four weeks

Study Arms (1)

icotinib+SBRT

EXPERIMENTAL

icotinib 125 milligram,three times a day for 28 days oral administration,12weeks later given the SBRT treatment depended on the outcome of icotinib

Drug: Icotinib; Radiation: SBRT

Interventions

Icotinib DRUG

icotinib 125 milligram three times a day

Also known as: Icotinib Hydric

icotinib+SBRT

SBRT RADIATION

given radiation for the primary lesion

Also known as: Stereotactic Body Radiation Therapy

icotinib+SBRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation.
• Stage disease according to the 7th Edition of the American Joint Committee on Cancer staging system
• Not received radiotherapy, chemotherapy or other biological treatment
• Measureable disease
• Life expectancy of\>=12 months
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
• Absolute neutrophil count (ANC)\>=2,500/mm\^3
• Hemoglobin\>=9.0 g/dL
• Total bilirubin\<=1.5 x upper limit of normal(ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine transferase \[ALT\])\<=2.5 x ULN in patients without liver or bone metastases; \<5 x ULN in patients with liver or bone metastases
• Cockcroft-Gault calculated creatinine clearance of\>=45 ml/min or creatinine\<=1.5 x ULN
• Prothrombin time (PT)\<=1.5 x ULN
• Partial thromboplastin time (PTT)\<=ULN
• Negative pregnancy test done\<=7 days prior to randomization, for women of childbearing potential only
• Provide informed written consent

You may not qualify if:

• Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• Known allergic to EGFR TKI any ingredients
• Prior chemotherapy or treatment for metastatic non-small cell lung cancer
• Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy\<=3 years prior to randomization;
• Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
• History of bleeding diathesis or coagulopathy
• Inadequately controlled hypertension (systolic blood pressure of\>150 mmHg or diastolic pressure\>100 mmHg on anti-hypertensive medications)
• Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury \<=28 days or core biopsy \<=7 days prior to randomization
• Pregnancy or breast-feeding women
• Other situation which researchers think that doesn't fit into the group

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

icotinib; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• juan li, MD

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

juan li, doctor

CONTACT

+8613880276636; dr.lijuan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Model Details: icotinib and SBRT treat the lung cancer with egfr mutation

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 15, 2017
• Study Start: June 2, 2017
• Primary Completion: November 2, 2017
• Study Completion: May 2, 2019
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share