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Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

Sponsor
Liaoning Tumor Hospital & Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05132985
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jan 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Icotinib+chemotherapy

Neoadjuvant chemotherapy (pemetrexed + carboplatin/cisplatin ) will start within 1-3 days from enrollment at 21-day (+/-3 days) intervals (Q3W) prior to surgery. Before surgery a tumor assessment will be done to exclude evidence of progression. Patients with radiographically stable disease or partial response may be considered for operation. Icotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of Icotinib is 125mg 1tt(Take 1 tablet 3 times a day) orally. Surgery: Surgery must be done within the 3rd to 4th week (+7 days) from day 21 cycle 2 of neoadjuvant treatment. Adjuvant treatment: Patients receive additional 2 cycles of platinum-based doublet chemotherapy(Researcher decide) on day 1 with intercalated icotinib (D8-15) every 3 weeks, and continued icotinib for 2 years or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity

Drug: Icotinib
125mg 1tt(Take 1 tablet 3 times a day) orally.
Other Names:
  • Conmana

    • Drug: Cisplatin
    75 mg/m2 (IV，Q3W)

    Drug: Carboplatin
    AUC 5 (IV, Q3W)

    Drug: Pemetrexed
    500 mg/m2 (IV, Q3W)

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. Overall survival(OS) [Up to approximately 72 months]

      OS will be defined as the time from randomization until death due to any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liaoning Cancer Hospital & Institute Shenyang Liaoning China 110000

    Sponsors and Collaborators

    • Liaoning Tumor Hospital & Institute

    Investigators

    • Principal Investigator: Hongxu Liu, Doctor, Liaoning Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    HongxuLiu, Professor, Liaoning Tumor Hospital & Institute
    ClinicalTrials.gov Identifier:
    NCT05132985
    Other Study ID Numbers:
    • NIC-0102
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by HongxuLiu, Professor, Liaoning Tumor Hospital & Institute
    NSCLC, EGFR, Icotinib
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung
    Carboplatin
    Pemetrexed

    Study Results

    No Results Posted as of Dec 10, 2021