Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel to Treat Lung Cancer

Study Overview
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Brief Summary
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There is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (EGFR) gene wild type non-small-cell lung cancer (NSCLC) . Icotinib is a new type of small molecule EGFR TKI, developed and patented by Zhejiang BetaPharma Co., Ltd.(Hangzhou, Zhejiang, China, Patent No. WO2003082830). It has the similar anti-tumor activity with gefitinib, erlotinib. Pre-clinical studies showed icotinib could significantly inhibit the EGFR tyrosine kinase activity. Notably, anti-tumor activities were observed in patients with advanced NSCLC. In this study, we will evaluate the efficiency of intermittent high dose of Icotinib in combination with Docetaxel as second-line treatment for NSCLC patients with wild type EGFR. The overall response rate(ORR),progression free survival(PFS) ,overall survival(OS) and health related quality of life(HRQoL) will be monitored.

Official Title
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Single Arm, Phase II Clinical Study of Intermittent High Dose of Icotinib in Combination With Docetaxel as Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR:

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed stage IIIB/IV NSCLC patients progressing after first-line chemotherapy; Patients must have stopped prior platinum-based therapy at least four weeks prior to enroll and fully recovered from chemotherapy-induced toxicity; Age: 18-70 years old; Patients with wild-type EGFR; With a histologically or cytologically confirmed measurable disease (longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to Response Evaluation Criteria in Solid Tumors (RECIST Criteria); Patients must have Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2; Must have an expected survival time of at least 12 weeks; Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) of ≥1.5 ´ 109/L, platelet count of ≥ 75´ 109/L; Hemoglobin(Hb) ≥ 9g/dL; adequate hepatic function: bilirubin ≤2x the upper limit of normal, glutamic-oxaloacetic transaminase(AST )and glutamate pyruvate transaminase(ALT)≤2x the upper limit of normal (≤5x the upper limit of normal if evidence of liver metastases); adequate renal function: bilirubin serum creatinine ≤1.5 x the upper limit of normal; No malabsorption or other gastrointestinal disorders affecting drug absorption; Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.Male patients must use at least one reliable form of contraception during treatment and within 3 months after treatment; Patients have provided a signed Informed Consent Form. Exclusion Criteria: Experience of Anti-EGFR Monoclonal Antibody or small molecular compounds therapy such as gefitinib, cetuximab, erlotinib or trastuzumab; Concomitant use with phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort; Allergic to icotinib or any of the excipients of this product. Prior chemotherapy with any paclitaxel agents; Central nervous system (CNS) metastases without radiotherapy and/or surgery; Evidence of clinically active Interstitial lung diseases; Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases; Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non melanoma skin cancer or cervical carcinoma in situ); Psychiatric illness that would prevent the patient from giving informed consent; Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study; Patient is concurrently using other approved or investigational antineoplastic agent; Pregnant or lactating women; Positive epidermal growth factor receptor mutation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent High Dose of Icotinib<br>Intermittent High Dose of Icotinib in Combination With Docetaxel: Icotinib 625mg tablet b ymouth three times per day for day1-2, Docetaxel 75mg/m2 injection intravenous drip for day 3, 3 weeks as 1 cycle | Drug: Icotinib<br> <br> Drug: Docetaxel<br> <br> * Other names: Taxotere, Docecad;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate(ORR) |  | 10-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival(PFS) |  | 10-12 months | 
| Overall Survival(OS) |  | 10-12momths | 
| Health Related Quality of Life(HRQoL) |  | 10-12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, Wild Type EGFR, Icotinib, Second-line Treatment