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The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation

Primary Purpose

Non-small Cell Lung Cancer(NSCLC)

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer(NSCLC)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent
Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation.
Clinically or pathologically confirmed stage IIIA- IIIB
Tolerable to complete resection of lung cancer
Able to comply with the required protocol and follow-up procedures, and able to receive oral medications
ECOG performance status 0-1.
Life expectancy ≥12 weeks.
Measurable disease must be characterized according to RECIST 1.1 criteria. Measurable lesions are defined as those that can be accurately measured in at least one dimension as ≥ 10mm by spiral CT scan.
Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥10 g/dL (may be transfused to maintain or exceed this level).
Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x upper limit of normal (ULN).
Adequate renal function: Serum creatinine ≤ 1.25 x upper limit of normal (ULN), and creatinine clearance≥ 60 ml/min.
Measurable disease according to the preset criteria .

Exclusion Criteria:

Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
Known severe hypersensitivity to Icotinib or any of the excipients of this product
Previous or current malignancies of other histologies within the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free survival of 5 years; cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix.
Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function.
Eye inflammation or eye infection not fully treated or predisposing factor of this.
Uncontrolled central nervous system (CNS) metastasis.
Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
Pregnancy or breast feeding.

Sites / Locations

Beijing Haidian HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib

Arm Description

Patients receive Icotinib PO TID for 8 weeks and then undergo thoracotomy.

Outcomes

Primary Outcome Measures

Complete resection rate

Secondary Outcome Measures

Objective response rate(ORR, i.e., complete response [CR] + partial response [PR])

Disease control rate (CR + PR+ stable disease)

Clinical down-staging

Progression free survival (PFS)

Overall survival (OS)

Number of Adverse Event

Full Information

NCT ID

NCT02820116

First Posted

June 22, 2016

Last Updated

June 29, 2016

Sponsor

Beijing Haidian Hospital

Collaborators

Peking University People's Hospital, 307 Hospital of PLA, 309th Hospital of Chinese People's Liberation Army

1. Study Identification

Unique Protocol Identification Number

NCT02820116

Brief Title

The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation

Official Title

An Open-label, Multicenter，Single-arm, Phase II Clinical Study of Icotinib for IIIA - IIIB NSCLC Patients With Epidermal Growth Factor Receptor Mutation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Haidian Hospital

Collaborators

Peking University People's Hospital, 307 Hospital of PLA, 309th Hospital of Chinese People's Liberation Army

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an open-label, multicenter, single-arm, phase II interventional clinical trial evaluating efficacy and safety of Icotinib as neoadjuvant treatment in patients with IIIA- IIIB NSCLC with activating EGFR mutation in exon 19 or 21. Sixty-seven resectable stage IIIA- IIIB NSCLC patients with EGFR activating (19/21) mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all the participants' biopsy samples and confirmed in surgical resected samples. Neoadjuvant treatment phase: Eligible patients will receive 125mg of Icotinib three times per day. Treatment will be scheduled to continue until the disease progression or unbearable toxicities appear. Surgery treatment phase: Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection. Post-surgery phase: It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up -- chest CT scan，abdominal abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan (ECT) every 12 months -- for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer(NSCLC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Icotinib

Arm Type

Experimental

Arm Description

Patients receive Icotinib PO TID for 8 weeks and then undergo thoracotomy.

Intervention Type

Drug

Intervention Name(s)

Icotinib

Other Intervention Name(s)

Conmana

Intervention Description

In the neoadjuvant treatment phase, eligible patients will receive 125mg of Icotinib three times per day for 8 weeks (56 days). In the post-surgery phase, Icotinib 125mg/three tims/day taken orally for 2 years or till disease progression or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Complete resection rate

Time Frame

Complete resection rate is depended on the pathology diagnosis after surgery, an expected average of 8 weeks from enrollment.

Secondary Outcome Measure Information:

Title

Objective response rate(ORR, i.e., complete response [CR] + partial response [PR])

Time Frame

Up to 5 years

Title

Disease control rate (CR + PR+ stable disease)

Time Frame

Up to 5 years

Title

Clinical down-staging

Time Frame

8 weeks

Title

Progression free survival (PFS)

Time Frame

Participants after surgery will receive long-term follow-up for up to 5 years

Title

Overall survival (OS)

Time Frame

Participants after surgery will receive long-term follow-up for up to 5 years

Title

Number of Adverse Event

Time Frame

Within 28 days of last study dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of informed consent Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation. Clinically or pathologically confirmed stage IIIA- IIIB Tolerable to complete resection of lung cancer Able to comply with the required protocol and follow-up procedures, and able to receive oral medications ECOG performance status 0-1. Life expectancy ≥12 weeks. Measurable disease must be characterized according to RECIST 1.1 criteria. Measurable lesions are defined as those that can be accurately measured in at least one dimension as ≥ 10mm by spiral CT scan. Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥10 g/dL (may be transfused to maintain or exceed this level). Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x upper limit of normal (ULN). Adequate renal function: Serum creatinine ≤ 1.25 x upper limit of normal (ULN), and creatinine clearance≥ 60 ml/min. Measurable disease according to the preset criteria . Exclusion Criteria: Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer. Known severe hypersensitivity to Icotinib or any of the excipients of this product Previous or current malignancies of other histologies within the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free survival of 5 years; cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function. Eye inflammation or eye infection not fully treated or predisposing factor of this. Uncontrolled central nervous system (CNS) metastasis. Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications. Pregnancy or breast feeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuqing Huang, doctor

Phone

+8601082693152

huangyuqing555@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jun liu, doctor

Phone

+8601082693152

liujundaifu@yahoo.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun liu, doctor

Organizational Affiliation

Peking University People Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Haidian Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuqing Huang, Doctor

Phone

+8601082693152

huangyuqing555@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Role of Icotinib in the Perioperative Treatment of IIIA - IIIB NSCLC Patients With EGFR Mutation

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