Non-small cell lung cancer
Conditions
Interventions
combined chemotherapy group:EGFR-TKI targeted therapy combined chemotherapy (pemetrexed plus carboplatin for 4 cycles)
control group:EGFR-TKI targeted therapy
Sponsors
The Fourth Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are willing to sign the informed consent form; 2. Patients aged 18-80 years (including boundary value) have no gender limit; 3. The patients with advanced or locally advanced NSCLC diagnosed by histology or cytology have stage IIIB to stage IV, which is not suitable for radical surgery and radiotherapy; 4. Patients who have not received systematic anti-tumor therapy (except neoadjuvant or adjuvant chemotherapy); 5. Patients with EGFR mutations associated with sensitivity to EGFR TKI; patients with EGFR mutations associated with T790M, TP53, Rb1, PTEN, cdkn, pik3a, DDRM or KRAS mutations; 6. The patient has at least one measurable lesion according to RECIST version 1.1, that is, the longest diameter is at least 10 mm. If the CT scan slice thickness is more than 5 mm, the minimum diameter of the lesion is 2 times of the slice thickness; if the lesion is a lymph node, the measured short diameter is at least 15 mm; the lesion has not received radiotherapy; 7. Patients with ECoG score of 0-1; 8. Patients with expected survival time >= 3 months; 9. Patients with basically normal hematological indexes: neutrophil absolute value >= 1.5x109/l, platelet >= 100 x109 / L, hemoglobin >= 90g / L; 10. Patients with normal liver function: total bilirubin = 60 ml / min (using Cockcroft Gault method); 12. Coagulation function was basically normal: Patients with INR <= 1.5; thirteen Patients of childbearing age (both male and female) are willing to use contraception (including but not limited to: hormonal contraception, physical contraception, or abstinence) from the date of signing the informed consent until 30 days after the last dose of study treatment; the pregnancy test of women of childbearing age is negative within 7 days before the plan to start the first dose of study drug treatment; and the male patients are from the beginning of the study treatment to the last dose of the study Sperm donation was not allowed 90 days after treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any of the following treatments: previous systemic anti-tumor therapy (except neoadjuvant or adjuvant chemotherapy); radiotherapy for more than 30% of bone marrow or large-area irradiation (except palliative radiotherapy for relieving pain of non target lesions) within 4 weeks before the first administration of study drug; other anti-tumor therapies, including molecular targeted therapy (Such as EGFR TKI, angiogenesis inhibitors), immunotherapy (such as cellular immunotherapy, anti-PD-1 or anti-PD-L1), and other experimental drug therapy; 2. Patients within 4 weeks before the first administration of the study drug had undergone major surgery; 3. Some drugs or herbal supplements that the patient is using (or cannot be stopped within 1 week before the first administration of the study drug) are known to be strong inducers of cytochrome P450 (CYP450) 3A4; 4. Patients with dysphagia or absorption disorder considered by researchers; 5. Patients with other primary malignant tumors, except for the following cases: Cured basal cell carcinoma or skin squamous cell carcinoma; Cervical carcinoma in situ; Superficial bladder cancer; The tumor has been cured and has been disease-free for 5 years or more; 6. Patients with brain metastases, except for the following: The diameter of the largest brain metastases was less than 2 cm, and there was no obvious symptom; The brain metastases were controlled and stable for more than 4 weeks; 7. Patients with clinically significant abnormalities in rhythm, conduction and morphology of resting electrocardiogram, such as complete left bundle branch block, cardiac block above grade II, PR interval > 250 ms, etc.; myocardial infarction occurred within 6 months; there are risk factors leading to QT interval prolongation or increased arrhythmia risk factors, such as heart failure, moderate or severe hypokalemia, diagnosed Or suspected congenital long QT syndrome, family history of long QT syndrome or sudden death of less than 40 years old in first-degree relatives; mean QTCF after friderica correction of three electrocardiograms: male > 450 ms, female > 470 Ms; 8. Pregnant or lactating women; 9. Patients with uncontrolled or active hepatitis B virus infection (HBsAg positive, HBV-DNA > 1000cps / ml and AST or ALT > 2.0xuln), hepatitis C virus infection or HIV infection; 10. Patients with other uncontrolled comorbidities include, but are not limited to, infections or active infections; 11. Patients with a history of epilepsy, mental illness, or other social factors limiting compliance with the protocol; 12. Patients considered unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactWang Kai
The Fourth Affiliated Hospital of Zhejiang University
Outcome results
None listed