EGF-R Positive Non-Small Cell Lung Cancer, NSCLC
Conditions
Keywords
NSCLC, EGFR, Icotinib
Brief summary
Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.
Interventions
DRUGIcotinib
125mg 1tt(Take 1 tablet 3 times a day) orally.
DRUGCisplatin
75 mg/m2 (IV，Q3W)
DRUGCarboplatin
AUC 5 (IV, Q3W)
DRUGPemetrexed
500 mg/m2 (IV, Q3W)
Sponsors
Liaoning Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Written informed consent * Male or female, aged ≥18 years and ≤75 years * Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology) * Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation * A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone * ECOG PS 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing * Adequate organ and marrow function as defined by: * Hemoglobin: ≥9.0 g/dL * Absolute neutrophil count: ≥1.5 × 109/l * Platelet count: ≥100 × 109/l * Serum bilirubin: ≤1.5 ULN * ALT and AST: ≤2.5 × ULN * Creatinine clearance: ≥60 ml/min * Life expectancy of 6 months prior to randomization
Exclusion criteria
* Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy * EGFR-TKI-sensitizing mutations with T790M * Mixed small cell and non-small-cell lung cancer histology * T4 tumors infiltrating the aorta, esophagus and/or heart * Bulky N2 disease * Candidates for segmentectomies or wedge resections only * Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD * Severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response(MPR) | Up to approximately 30 months | Patients with tumors with ≤10% residual viable cancer cells (identified by routine hematoxylin and eosin staining) in the lung primary tumor after neoadjuvant treatment at the time of resection will be considered to have had an MPR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | Up to approximately 30 months | Patients with no residual viable tumor cells in any of the specimens (primary tumors, lymph nodes and margins) will be considered to have had a pCR. |
| Objective response rate(ORR) | Up to approximately 30 months | defined as the sum of the complete response plus partial response divided by the total number of included patients. |
| R0 resection rate | Up to approximately 30 months | Free resection margins proved microscopically;Systematic nodal dissection in its wider form or, if it is not performed, lobe-specific systematic nodal dissection;There should be no extracapsular extension of tumor in nodes removed separately or those at the margin of the main lung specimen. ;The highest mediastinal node that has been removed must be negative. |
| Disease-free survival(DFS) | Up to approximately 72 months | DFS will be defined as the time from surgery until the first instance of disease recurrence (local or distant) or death due to any cause, whichever occurs first. |
| Overall survival(OS) | Up to approximately 72 months | OS will be defined as the time from randomization until death due to any cause. |
Countries
China
Outcome results
None listed