Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
RIPOT1606
- NCT ID:
NCT02820116
Conditions
- Non-small Cell Lung Cancer(NSCLC)
Interventions
Drug | Synonyms | Arms |
---|
Icotinib | Conmana | Icotinib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Icotinib | Experimental | Patients receive Icotinib PO TID for 8 weeks and then undergo thoracotomy. | |
Eligibility 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.
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Complete resection rate |
Time Frame: | Complete resection rate is depended on the pathology diagnosis after surgery, an expected average of 8 weeks from enrollment. |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate(ORR, i.e., complete response [CR] + partial response [PR]) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (CR + PR+ stable disease) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Clinical down-staging |
Time Frame: | 8 weeks |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) |
Time Frame: | Participants after surgery will receive long-term follow-up for up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Participants after surgery will receive long-term follow-up for up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Number of Adverse Event |
Time Frame: | Within 28 days of last study dose |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Beijing Haidian Hospital |
Last Updated
June 30, 2016