Non Small Cell Lung Cancer
Conditions
Keywords
non small cell lung cancer, Gefitinib, EGFR negative, Pemetrexed
Brief summary
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
Detailed description
In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.
Interventions
DRUGpemetrexed/cisplatin intercalating gefitinib
Sponsors
Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.Histological or cytological diagnosis of small-cll lung cancer histology 2.18 years or older 3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2 4.Local stage SCLC without distant metastases 5.After 1st-line chemotherapy (EP or IP) at least 4 cycles 6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy 7.CR or PR assessment by RECIST(1.0) before randomized 8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L 9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases 10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Exclusion criteria
1. Mixed non-small cell lung cancer histology 2. Neck and supraclavicular lymph node metastasis 3. Be allergic to temozolomide or intolerable to radiotherapy 4. Any unstable systemic disease 5. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease progression-free survival | 3 years | the last patient into group for three years or dead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | the last patients into group for 5 years or dead |
| side-effects | 3 years | the last patient into group for 3 years or dead |
| overall response rate | 3 years | the last patient into group for 3 years or dead |
Countries
China
Contacts
Primary ContactHailing Yang, MD
Backup ContactFengnan Wang, MD
Outcome results
None listed