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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first-line erlotinib | Experimental | erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment |
|
| second-line erlotinib | Active Comparator | docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib 150 mg/d per os until proven disease progression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | three year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang-An Chen, MD, phD | Contact | 86-10-66939361 | chenla301@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Liang-An Chen, M.D., Ph.D. | Chinese PLA General Hospital, Beijing, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| Docetaxel |
| Drug |
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment |
|
| Cisplatin | Drug | cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment |
|
| Docetaxel | Drug | Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most |
|
| Cisplatin | Drug | Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most |
|
| Erlotinib | Drug | Erlotinib 150 mg/d per os as second-line treatment |
|
| 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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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