Status:
UNKNOWN
Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
Lead Sponsor:
Guangzhou Medical University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- Histological or cytological diagnosis of small-cll lung cancer histology
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- Local stage SCLC without distant metastases
- After 1st-line chemotherapy (EP or IP) at least 4 cycles
- After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
- CR or PR assessment by RECIST(1.0) before randomized
- Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
- 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
- Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Exclusion
- Mixed non-small cell lung cancer histology
- Neck and supraclavicular lymph node metastasis
- Be allergic to temozolomide or intolerable to radiotherapy
- Any unstable systemic disease
- Pregnant or lactating women
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT03374280
Start Date
December 1 2016
End Date
December 30 2021
Last Update
March 28 2019
Active Locations (1)
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1
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, China, 510120