A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Study Overview
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Brief Summary
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Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .

Official Title
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Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Conditions
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Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Drug Therapy, Genes, EGFR

Intervention / Treatment
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* Drug: Erlotinib
* Drug: Docetaxel
* Drug: Cisplatin
* Drug: Docetaxel
* Drug: Cisplatin
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged over 18 years Histologically proven lung adenocarcinoma clinical stage IIIB/IV ECOG performance status 0-2 Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma At least one measurable lesion (according to RECIST) Provision of written informed consent Life expectancy of at least 12 weeks Exclusion Criteria: History of malignant disease. Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) Expected life expectancy less than 2 months As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: first-line erlotinib<br>erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment | Drug: Erlotinib<br>* Erlotinib 150 mg/d per os until proven disease progression<br>Drug: Docetaxel<br>* Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment<br>Drug: Cisplatin<br>* cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment<br>|
| Active Comparator: second-line erlotinib<br>docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment | Drug: Docetaxel<br>* Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most<br>Drug: Cisplatin<br>* Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most<br>Drug: Erlotinib<br>* Erlotinib 150 mg/d per os as second-line treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | three year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival during the first-line treatment |  | 1 year | 
| progression-free time during the second-line treatment |  | 2 years | 
| quality of life during the first-line therapy |  | every 3 weeks during first-line therapy | 
| quality of life during the second-line therapy |  | every 3 weeks during the second-line therapy | 
| response rates during the first-line treatment |  | at 6 months from treatment initiation | 
| response rates during the second-line treatment |  | every 3 weeks during the treament, and and every 6 weeks thereafter | 
| toxicity during the first-line treatment |  | at 12 months from treatment initiation | 
| toxicity during the second-line treatment |  | end of study | 
| preditive and prognostic markers for chemotherapy or erlotinib | tissues for markers analysis are acquired during diagnosis procedure with informed consent. | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mutation analysis, first-line, second-line, targeted therapy