KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy

Study Overview
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Brief Summary
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This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.

Official Title
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A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: KD019
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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For Eligibility subjects must have: failed one or two previous courses of therapy. have no active brain metastasis. Treated non-active brain metastasis are acceptable. cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva [erlotinib] or Iressa [gefitinib]) in the past. has demonstrated progressive disease.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KD019<br>KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted. | Drug: KD019<br>* KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.<br>* Other names: XL647;|
| Active Comparator: Erlotinib<br>Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted. | Drug: Erlotinib<br>* Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year | 
| Number and type of adverse events related to KD019 | For the purpose of data collection, all untoward events that occur after informed consent through 30 days after last dose of study treatment are to be recorded. | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year | 
| Objective response rate |  | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year |