Clinical trial NCT05132985: Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma
Official title: Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: NSCLC
EGF-R Positive Non-Small Cell Lung Cancer
Keywords: NSCLC, EGFR, Icotinib
Lead sponsor: Liaoning Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Major pathological response(MPR)
timeFrame: Up to approximately 30 months
Secondary outcomes:
measure: Pathological complete response (pCR)
timeFrame: Up to approximately 30 months
measure: Objective response rate(ORR)
timeFrame: Up to approximately 30 months
measure: R0 resection rate
timeFrame: Up to approximately 30 months
measure: Disease-free survival(DFS)
timeFrame: Up to approximately 72 months
measure: Overall survival(OS)
timeFrame: Up to approximately 72 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
Study officials:
affiliation: Liaoning Cancer Hospital & Institute
name: Hongxu Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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