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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02820116
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
Peking University People's Hospital
307 Hospital of PLA
309th Hospital of Chinese People's Liberation Army
Information provided by (Responsible Party):
Huang Yuqing, Beijing Haidian Hospital

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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer(NSCLC) Drug: Icotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2016
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Icotinib
Patients receive Icotinib PO TID for 8 weeks and then undergo thoracotomy.
Drug: Icotinib
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.
Other Name: Conmana




Primary Outcome Measures :
  1. 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 Measures :
  1. Objective response rate(ORR, i.e., complete response [CR] + partial response [PR]) [ Time Frame: Up to 5 years ]
  2. Disease control rate (CR + PR+ stable disease) [ Time Frame: Up to 5 years ]
  3. Clinical down-staging [ Time Frame: 8 weeks ]
  4. Progression free survival (PFS) [ Time Frame: Participants after surgery will receive long-term follow-up for up to 5 years ]
  5. Overall survival (OS) [ Time Frame: Participants after surgery will receive long-term follow-up for up to 5 years ]
  6. Number of Adverse Event [ Time Frame: Within 28 days of last study dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent
  2. Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation.
  3. Clinically or pathologically confirmed stage IIIA- IIIB
  4. Tolerable to complete resection of lung cancer
  5. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications
  6. ECOG performance status 0-1.
  7. Life expectancy ≥12 weeks.
  8. 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.
  9. 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).
  10. 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).
  11. Adequate renal function: Serum creatinine ≤ 1.25 x upper limit of normal (ULN), and creatinine clearance≥ 60 ml/min.
  12. Measurable disease according to the preset criteria .

Exclusion Criteria:

  1. Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
  2. Known severe hypersensitivity to Icotinib or any of the excipients of this product
  3. 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.
  4. 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).
  5. Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function.
  6. Eye inflammation or eye infection not fully treated or predisposing factor of this.
  7. Uncontrolled central nervous system (CNS) metastasis.
  8. Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
  9. 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.
  10. Pregnancy or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820116


Contacts
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Contact: Yuqing Huang, doctor +8601082693152 huangyuqing555@gmail.com
Contact: Jun liu, doctor +8601082693152 liujundaifu@yahoo.cn

Locations
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China, Beijing
Beijing Haidian Hospital Recruiting
Beijing, Beijing, China, 100080
Contact: Yuqing Huang, Doctor    +8601082693152    huangyuqing555@gmail.com   
Sponsors and Collaborators
Beijing Haidian Hospital
Peking University People's Hospital
307 Hospital of PLA
309th Hospital of Chinese People's Liberation Army
Investigators
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Principal Investigator: Jun liu, doctor Peking University People Hospital

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Responsible Party: Huang Yuqing, Deputy Director, Beijing Haidian Hospital
ClinicalTrials.gov Identifier: NCT02820116    
Other Study ID Numbers: RIPOT1606
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases