Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

Study Overview
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Brief Summary
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To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC

Detailed Description
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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.

Official Title
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The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed/cisplatin intercalating gefitinib
* Drug: pemetrexed/cisplatin


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pemetrexed/cisplatin intercalating gefitinib<br>pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles. pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable | Drug: pemetrexed/cisplatin intercalating gefitinib<br> <br> |
| Active Comparator: pemetrexed/cisplatin<br>pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable | Drug: pemetrexed/cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease progression-free survival | the last patient into group for three years or dead | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the last patients into group for 5 years or dead | 5 years | 
| side-effects | the last patient into group for 3 years or dead | 3 years | 
| overall response rate | the last patient into group for 3 years or dead | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non small cell lung cancer, Gefitinib, EGFR negative, Pemetrexed