NSCLC
Conditions
Interventions
Active Comparator Arm:Investigator-choice therapy: Erlotinib 150mg PO once daily or 500 milligrams per square meter (mg/m2) Pemetrexed and AUC=5 Carboplatin/75 milligrams per square meter (mg/m2) cisp
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this study: 1. Objects over 18 years old (including 18 years old) and under 75 years old (including 75 years old); 2. Non scaly NSCLC patients of IIIA stage (AJCC stage 8) who have not been treated before and have been confirmed to be resectable or potentially resectable by histology, in which N2 is defined as single station mediastinal lymph node non massive metastasis (lymph node short diameter = 10 mm (in case of lymph nodes, the shortest diameter is required to be >= 15 mm). The selected measurement method is suitable for accurate repeated measurement, which can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion, it can be accepted as the target lesion. The baseline evaluation of tumor lesions should be conducted at least 14 days after the diagnostic biopsy. 6. Women of childbearing age need to take appropriate contraceptive measures and should not breastfeed 3 months after screening and stopping the research and treatment. Prior to the start of administration, the pregnancy test was negative, or one of the following criteria was met to demonstrate that there was no risk of pregnancy: a. Postmenopause is defined as amenorrhea in patients over 50 years of age and at least 12 months after cessation of all hormone replacement therapy. b. Women younger than 50 years old can also be considered as postmenopausal women if they have amenorrhea for 12 months or more after stopping all exogenous hormone treatment, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference values. c. Subjects who had undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except for bilateral tubal ligation. 7. Barrier contraception (i.e. condom) should be used in male patients from screening to 3 months after discontinuation of study treatment. 8. The subject voluntarily participated and signed the informed consent in writing.
Exclusion criteria
Exclusion criteria: Subjects were not included in the study if they met any of the following criteria: 1. Patients who have received any of the following treatments: (1) The target lesion of lung cancer was removed by previous operation; (2) Previous use of any EGFR-TKI treatment; (3) Previous chemotherapy for lung cancer; (4) Previous radiotherapy for lung cancer; (5) Within 4 weeks before the first administration of the study drug, the patient had undergone major surgery; (6) Within 7 days before the first administration of the study drug, CYP3A4 strong inhibitors, inducers or drugs with narrow therapeutic window for CYP3A4 sensitive substrate were used. 2. Patients who have any complications or other malignant tumors and need treatment or major surgery within 2 years after the first administration of the study treatment; 3. At the beginning of the study, patients with unresponsive past treatment residual toxicity greater than CTCAE level 1, except those with alopecia and neurotoxicity Level 2; 4. Spinal cord compression or brain metastasis, except for asymptomatic and stable patients, who do not need steroid treatment at least 2 weeks before the first administration of the study treatment; 5. Patients who received yellow fever vaccine or other live attenuated vaccine during pemetrexed treatment; 6. According to the judgment of researchers, patients with any serious or poorly controlled systemic diseases, such as poor control of hypertension, active bleeding prone constitution or active infection. No need to check chronic diseases; 7. Patients with intractable nausea, vomiting or chronic gastrointestinal diseases who can't swallow the study drug or have undergone a large-scale enterotomy may affect the full absorption of amitinib; 8. the results of one of the following cardiac examinations were met: (1) The mean corrected QT interval (QTC) > 470 msec was obtained from three ECG examinations at rest. The friderica formula was used for QTc correction (QTCF); (2) Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, third degree atrioventricular block, second degree atrioventricular block and PR interval > 250 msec); (3) There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or sudden unexplained death of immediate family members under 40 years old or any combination drugs that extend QT interval; (4) LVEF 2.5 times the upper limit of normal (ULN); (6) Aspartate aminotransferase > 2.5 * ULN; (7) Total bilirubin > 1.5 * ULN, or Gilbert syndrome (unconjugated hyperbilirubinemia); (8) Creatinine > 1.5 * ULN and creatinine clearance 1.5 * ULN; 11. Women with positive pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR;MPR;DFS;OS;Complete resection rate;Degradation rate;Disease free rate at week24 & week48;afety and tolerability; | — |
Countries
China
Contacts
Public ContactWenhua Liang
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed