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

November 28, 2021 updated by: HongxuLiu, Liaoning Tumor Hospital & Institute

Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major pathological response(MPR)
Time Frame: 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.
Up to approximately 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR)
Time Frame: 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.
Up to approximately 30 months
Objective response rate(ORR)
Time Frame: Up to approximately 30 months
defined as the sum of the complete response plus partial response divided by the total number of included patients.
Up to approximately 30 months
R0 resection rate
Time Frame: 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.
Up to approximately 30 months
Disease-free survival(DFS)
Time Frame: 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.
Up to approximately 72 months
Overall survival(OS)
Time Frame: Up to approximately 72 months
OS will be defined as the time from randomization until death due to any cause.
Up to approximately 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning Tumor Hospital & Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

January 1, 2028

Study Registration Dates

First Submitted

November 14, 2021

First Submitted That Met QC Criteria

November 14, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

November 28, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIC-0102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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