Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease

Study Overview
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Brief Summary
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The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.

Detailed Description
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This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.

Official Title
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An Open-label, Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Icotinib of routine dose
* Drug: Icotinib of high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology) No previous targeted treatment such as gefitinib, erlotinib. With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) at least according to RECIST Criteria WHO performance status(PS)<= 2 N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN. Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: Allergic to icotinib Patients with metastatic brain tumors with symptoms. Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Icotinib of Routine Dose<br>Oral Drug icotinib 125 mg three times per day | Drug: Icotinib of routine dose<br>* Icotinib of routine dose: 125 mg is administered orally three times per day.<br>* Other names: BPI-2009;|
| Experimental: Icotinib of High Dose<br>Oral Drug icotinib 250 mg three times per day | Drug: Icotinib of high dose<br>* Icotinib: 250 mg is administered orally three times per day.<br>* Other names: BPI-2009;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive. | 15 months | 
| Transformation rate from stable disease to complete response or partial response | Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response. | 6 weeks | 
| Incidence rate of adverse events | Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication. | 40 months |