Non-small cell lung cancer
Conditions
Interventions
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent prior to implementing any trial-related procedures; 2.Aged 18 to 75 years, male or female; 3.Histological or cytological diagnosed of lung adenocarcinoma within 60 days before study enrollment; 4.Stage cIIIA (T4N0M0,T3-4N1M0, T1A-2BN2M0) was resectable by PETCT imaging and mediastinal lymph node biopsy (8th edition TNM staging). 5.EGFR mutation positive (must include deletion of exon 19 and/or mutation of exon 21 L858R, which can exist alone or in combination); 6.Presence of at least one accurately measurable lesion, computed tomography (CT) showing a maximum diameter of >10mm at baseline (except for lymph nodes with a shorter axis > 15mm) and suitable for accurate repeat measurements; 7.ECOG performance status score 0-1; 8.Sufficient organ function to meet protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Tumors with neuroendocrine components such as squamous cell carcinoma, large cell carcinoma or small cell carcinoma; 2.Other anti-tumor treatments were received before enrollment; 3.EGFR gene detection showed 20 exon insertion mutation; 4.Women in pregnancy or lactation; 5.Drugs or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks ago) are currently being received (or cannot be stopped before receiving the first dose of study treatment); 6.Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, or any active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol. The screening of chronic diseases is not required; 7.Any of the following cardiac criteria: the average resting corrected QT interval (QTC) > 470 milliseconds obtained from 3 electrocardiogram (ECG) examinations using the QTc value obtained by the screening clinic electrocardiograph; Abnormal rhythm, conduction or morphology of any clinically significant resting ECG, such as left bundle branch block, third degree heart block and second degree heart block; Any factor that increases the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication with unexplained sudden death under the age of 40 in first-degree relatives or known prolongation of QT interval; 8.Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or any evidence of active interstitial lung disease; 9.Lack of adequate bone marrow reserve or organ function (it is proved 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-fold ULN, only the creatinine clearance rate needs to be confirmed); 10.Other malignant tumors or history of other malignant tumors in the last 5 years, except skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ, which have been effectively controlled; 11.Hypersensitivity history of active or inactive excipients of furmonertinib or drugs with similar chemical structure or category to furmonertinib; 12.Uncontrollable nausea and vomiting, chronic gastrointestinal diseases, inability to swallow formulated drugs, or previous major intestinal resection that would prevent adequate absorption of furmonertinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Pathological complete response rate;N2 staging downregulation rate;R0 resection rate;Progression free survival;Overall survival;Surgical complications; | — |
Countries
China
Contacts
Public ContactMa Kai
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Hospital
Outcome results
None listed