NSCLC
Conditions
Interventions
control arm:icotinib
test arm:icotinib combined with thoracic radiotherapy
Sponsors
Shandong Province Cancer Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 Years and older; 2. Pathologically proven (either histologic or cytologic) diagnosis of non-small cell lung cancer; 3. IIIB/IV stagedistance metastasis number3clear consciousness if metastases in brain; few intrapulmonary metastasizes with normal lung function and the intrapulmonary lesions could be included in radiotherapy field; bone metastasis with no influence on QoL i.e. Pathological fracture; 4. EGFR sensitive mutations (EGFR 19 DEL or L858R); 5. At least one measurable lesions based on RECIST 1.1, longest diameter >10mm; 6. ECOG performance status 0-1; 7. The pulmonary lesions could be used by IMRT technic, DTGTV>=56GyLung V2012 weeks; 9. Major organs function meet the following criteria; (1) MarrowWBC>4.0*10^9/Lneutrophil>=1.5*10^9/LPlatelets100*10^9/LHgb>=90g/L; (2) LiverTotal bilirubin=60ml/min; 10. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment; 11. Patient must sign study specific informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: 1. Target therapy ie. Erlotinib,gefitinib, Cetuximab, transtuzumab etc.; 2. Any anti-tumor therapy including cytostatic therapy, target therapy, investigational treatment, radiotherapy etc.; 3. upper digest dysfunction, absorb dysfunction, or cannot absorb oral drugs, or active gastrointestinal ulcers; 4. Except NSCLC, the subject had the other cancers within 5 years (except resected tumors with 5 years DFS, or curable carcinoma in situs of cervix, basal cell carcinoma and bladder cancer); 5. I-IIIb stage NSCLC; 6. Contain SCLC in histologic tissues; 7. Malignance pleural effusion, pericardial effusion patients; 8. Moderate-severe COPD, ILD or idiopathic pulmonary fibrosis; 9. Allergy to EGFR-TKI drugs; 10. Any diseases, or any contraindication to investigational drugs; 11. Any severe, active co-morbidity, including active infectionsuncontrolled hypertension, Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months), any history of clinically significant arrhythmias, or any liver, kidney or metabolic disease needed systemic treatment; 12. HIV infection, active hepatitis (HBV DNA positive); 13. Any systemic diseases need to be intervention or active infection within 2 weeks before enrollment the study; 14. Be pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Side effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactLi Bao Sheng
Outcome results
None listed