non-small cell lung cancer
Conditions
Interventions
Gold Standard:
Index test:
Sponsors
Shanghai 9th People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged = 18 years; 2. Locally advanced or metastatic non-small cell lung cancer (NSCLC) was proven histologically or cytologically. Patients with advanced NSCLC stage IV or IIIB with or without pleural effusion may be enrolled. If there is no pleural invasion, the patients with stage IIIB can only be selected who can not tolerate synchronized chemoradiotherapy or chemotherapy; 3. EGFR mutation, exon 19 Del or exon 21 L858R, must be confirmed before enrollment. Additional biopsies may not be performed for the purpose of this study; 4. There is at least one measurable lesion based on the solid tumor response evaluation criteria (RECIST); 5. Patients should meet the following hematologic indicators.Hemoglobin =10 g/dL; Platelet count = 100×10^9/L; neutrophil count = 1.5×10^9/L; 6. Patients should meet the following biochemical parameters: (1) Total bilirubin = 1.5×normal upper limit (ULN) (Gilbert syndrome patients with total bilirubin levels must be <4 times the normal upper limit); (2) AST and ALT <1.5 (ULN) (<5-fold normal upper limit if associated with liver metastasis); (3) Upper limit of normal serum creatinine <1.5 times; (4) Creatinine clearance =60 ml / min. 7. KPS score = 60 points (ECOG <2); 8. Women of childbearing age must take reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days before enrollment and the result is negative.The women are willing to take appropriate measures during the trial and at the end of the 8 weeks after the last test contraception. For men, it is agreed that appropriate methods of contraception or surgical sterilization should be used during the trial and at the end of the 8 weeks after the last administration of the test drug; 9. Patients with cerebrovascular disease in the whole brain after radiotherapy or anti-edema treatment can be enrolled (no time limit). The clinical symptoms caused by cerebrovascular disease can be controlled or asymptomatic; 10. Participants voluntarily joined the study and signed informed consent.His or her compliance is good and intend to follow up.
Exclusion criteria
Exclusion criteria: 1. Survival time of patients is expected to be less than 2 months; 2. Treatment with EGFR-TKI, Iressa or Tarceva before the trial; 3. Hormone anti-cancer therapy (allowing continued use of antiandrogens and / or Gonadorelinum analogue to treat prostate cancer) within 14 days prior to initiation of study; 4. The patient received the radiotheray for a period of 14 days prior to the initiation of the study, with the exception of the following: (1) Palliative radiotherapy for up to 14 days prior to administration of other organs outside the chest; (2) The patient with palliative treatment for a symptom of a single non-permissive condition should be discussed with the sponsor prior to enrollment. 5. A major surgery was performed within four weeks from Iressa treatment for the first time. Minor surgery (including implantation of external equipment or fine needle aspiration) should be performed at least 7 days after surgery and at least 14 days after diagnostic or palliative thoracoscopic surgery (VATS); 6. The patients had other medical history of malignancy.The patients underwent surgery or radiotherapy for removal of metastatic lesions during the study; 7. Researchers believe that patients with previous or current clinical-related cardiovascular abnormalities, such as uncontrolled hypertension, grade 3 or more congestive heart failure (NYHA), unstable angina or poorly controlled arrhythmias. Myocardial infarction was initiated within 6 months of starting the study; 8. The patients had other parts of the past or associated with malignant tumors, with the exception of the effective treatment of non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or effective treatment, remission over 3 years and that has cured malignant tumors; 9. The patients had pial meningeal metastases or spinal cord compression. Patients with brain metastases under conditions of treatment, asymptomatic, and stable (steroid hormone therapy not required for at least 4 weeks prior to initiation of the study) were enrolled; 10. The patient has been suffering from interstitial lung disease; 11. According to the investigator's assessment, poorly controlled gastrointestinal disease may affect the absorption of the test drug (eg, Crohn's disease, ulcerative colitis, malabsorption or any cause of CTC=2 grade diarrhea); 12. The patients had active hepatitis B virus infection (HBsAg + and / or HBV DNA +), active HCV infection (HCV RNA +) and / or HIV; 13. The patients should accept contraceptive methods or unplanned use of these contraceptive methods during the study period with below conditions: (1) breastfeeding; (2) pregnant; (3) do not agree to accept the requirements of the test program pregnancy test. Perimenopausal women must be menopaused for at least 24 months before they can be considered fertility-free. 14. The patient is undergoing other trials to prohibit the use of combination therapy, and can not be discontinued during the study; 15. Allogeneic bone marrow transplantation was performed, or within 120 days prior to initiation of the study, whole blood without leukocyte depletion was infused; 16. Hypersensitivity to Iressa or any excipient is known; 17. Anything that is not suitable for venous blood sampling; 18. The investigators believe that the patient's history or complication may influence the patient's ability to comply with the trial or interfere with the assessment of the safety of the test drug; 19. Other circu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the timepoint of acquired EGFR T790M in CTCs; | — |
Secondary
| Measure | Time frame |
|---|---|
| the sensitivity and specificity of acquired EGFR T790M in CTCs; | — |
Countries
China
Contacts
Public ContactBin Jiang
Shanghai 9th People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed