Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation
Primary Purpose
Lung Cancer Stage IV
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Icotinib
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer Stage IV focused on measuring EGFR mutation icotinib SBRT
Eligibility Criteria
Inclusion Criteria:
- 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
- Willing to return to Sichuan cancer hospital for follow-up
- Willing to provide tissue and blood samples for correlative research purposes
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
icotinib+SBRT
Arm Description
icotinib 125 milligram,three times a day for 28 days oral administration,12weeks later given the SBRT treatment depended on the outcome of icotinib
Outcomes
Primary Outcome Measures
progression free survival
the time to disease to progression according the RESCIT
Secondary Outcome Measures
object responsible rate
the proportion the patients have receives the complete remission and partial remission
Full Information
NCT ID
NCT03153358
First Posted
May 7, 2017
Last Updated
May 13, 2017
Sponsor
Sichuan Cancer Hospital and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03153358
Brief Title
Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation
Official Title
Icotinib Combined With Stereotactic Body Radiation Therapy (SBRT) for Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Sensitive Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2017 (Anticipated)
Primary Completion Date
November 2, 2017 (Anticipated)
Study Completion Date
May 2, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Lung cancer is the leading cause of cancer morbidity and mortality worldwide. The majority of lung cancer is nonsquamous NSCLC. EGFR tyrosine kinase inhibitors (EGFR-TKI) is a effective first-line treatment for EGFR mutations non-squamous NSCLC treatment.Icotinib is the first EGFR-TKI,and have been proved efficiently in the treatment of lung cancer, and SBRT become a main therapy for the primary lesion,Accordingly, we have come to a scientific hypothesis that icotinib combination with SBRT might be a better treatment strategy for stageIV non-squamous NSCLC patients with EGFR mutation. It can improve the PFS of stage ⅢB/Ⅳ non-squamous NSCLC patients with EGFR mutation . The primary endpoint is disease-free time to progression (PFS). The secondary study endpoint is objective response rate (ORR), disease control rate (DCR),overall survival(OS) safety and quality of life (QOL). Through this study lay the foundation for further exploration of the non-squamous NSCLC first-line treatment in patients with EGFR mutation strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Stage IV
Keywords
EGFR mutation icotinib SBRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
icotinib and SBRT treat the lung cancer with egfr mutation
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
icotinib+SBRT
Arm Type
Experimental
Arm Description
icotinib 125 milligram,three times a day for 28 days oral administration,12weeks later given the SBRT treatment depended on the outcome of icotinib
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Icotinib Hydric
Intervention Description
icotinib 125 milligram three times a day
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
given radiation for the primary lesion
Primary Outcome Measure Information:
Title
progression free survival
Description
the time to disease to progression according the RESCIT
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
object responsible rate
Description
the proportion the patients have receives the complete remission and partial remission
Time Frame
four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Willing to return to Sichuan cancer hospital for follow-up
Willing to provide tissue and blood samples for correlative research purposes
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
juan li, doctor
Phone
+8613880276636
Email
dr.lijuan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
juan li, MD
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Icotinib Combined With SBRT for Patients With Metastatic Non-squamous NSCLC With EGFR Mutation
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