Carcinoma, Non-Small Cell Lung, Drug Therapy, Genes, EGFR, Neoplasms, Lung
Conditions
Keywords
mutation analysis, first-line, second-line, targeted therapy
Brief summary
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 .
Interventions
DRUGErlotinib
Erlotinib 150 mg/d per os until proven disease progression
DRUGDocetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
DRUGCisplatin
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | three year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| progression-free survival during the first-line treatment | 1 year | — |
| 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 | end of study | tissues for markers analysis are acquired during diagnosis procedure with informed consent. |
| response rates during the second-line treatment | every 3 weeks during the treament, and and every 6 weeks thereafter | — |
Countries
China
Contacts
Primary ContactLiang-An Chen, MD, phD
Outcome results
None listed