Operable non-small cell lung cancer in stages ?b - ?b
Conditions
Interventions
experimental group:icotinib
Sponsors
Tianjin Cancer Hospital Airport Hospita
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and sign the informed consent form; 2. Age 18-75 years old; 3. Histologically or cytologically confirmed lung adenocarcinoma; 4. No systemic treatment for non-small cell lung cancer; 5. Clinical stage II.b-III.B (N1-N2) is resectable by EBUS-TBNA or PET/CT; 6. EGFR 19del or L858R mutation; 7. At least one measurable lesion according to RECIST 1.1; 8. ECOG score 0-1 points; 9. Hematology and liver and kidney function are sufficient for neoadjuvant therapy; 10. Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function, blood gas analysis, etc.); 11. Female subjects should use highly effective contraception for at least 2 weeks prior to starting study drug, must have a negative pregnancy test, and have no ongoing breastfeeding prior to starting dosing, or otherwise must meet one of the following criteria at screening that demonstrates the possibility of non-childbearing potential: (1) Postmenopausal is defined as age over 50 years old and amenorrhea for at least 12 months after stopping all exogenous hormone therapy; (2) Women under the age of 50 should be considered postmenopausal if they have been postmenopausal for 12 months or more after discontinuation of exogenous hormonal therapy and if LH and FSH levels are within the postmenopausal range of the institution; (3) Irreversible surgical castration documented by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but excluding tubal ligation. 12. Male subjects must be willing to use barrier contraception.
Exclusion criteria
Exclusion criteria: 1. Tumors with neuroendocrine components such as squamous cell carcinoma, large cell carcinoma, or small cell carcinoma; 2. Exposure to other anti-tumor treatments before enrollment; 3. EGFR gene detection with 20 exon insertion mutations; 4. Patient is pregnant or breastfeeding; 5. Currently receiving (or unable to discontinue use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks ago). All patients must try to avoid concomitant use or ingestion of any medications, herbal supplements, and/or foods known to have inducing effects on CYP3A4. 6. Evidence of any severe or uncontrolled systemic disease, including: a) uncontrolled hypertension; b) Active bleeding; c) Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); d) Any other evidence that, in the opinion of the investigator, would be unfavorable for the patient's participation in the study or would disrupt protocol compliance. 7. Any of the following cardiac diseases: a) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiogram (ECG) examinations using QTc values obtained using the screening clinic ECG machine; b) Any clinically significant rhythm, conduction, or morphological abnormality on resting ECG, such as left bundle branch block, third-degree heart block, and second-degree heart block; c) Any factor that would increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death under 40 years of age in a first-degree relative or any concomitant medication known to prolong the QT interval; 8. Prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease; 9. Lack of adequate bone marrow reserve or organ function (as evidenced by any of the following laboratory values: absolute neutrophil count 2.5 times ULN; aspartate aminotransferase > 2.5 times ULN; Total bilirubin > 1.5 times ULN; Serum creatinine >1.5 times ULN with creatinine clearance 1.5 times ULN); 10. History of hypersensitivity to active or inactive excipients of the study drug or drugs with similar chemical structure or class, as well as uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated drug, or underwent major bowel resection surgery that would prevent adequate absorption of the study drug; 11. Other situations that the investigator considers unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathology remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Overall survival;Disease-free survival;Adverse events;pCR;R0 resection rate;Objective remission rate; | — |
Countries
China
Contacts
Public ContactJianYou
Tianjin Cancer Hospital Airport Hospita
Outcome results
None listed