Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Official Title
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A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study

Conditions
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Non-small Cell Lung Cancer, Efficacy

Intervention / Treatment
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* Drug: cisplatin, dexamethasone,vitamin B12, folic acid
* Drug: cisplatin, gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors; with an Eastern CooperativeOncology Group performance status of 0 or 1, At least 18 years of age adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment patients had fully recovered from its acute effects. Exclusion Criteria: peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1 progressive brain metastases, uncontrolled third-space fluid retention before study entry. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.

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: Group A<br> | Drug: cisplatin, dexamethasone,vitamin B12, folic acid<br>* Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment<br>|
| Active Comparator: Group B<br> | Drug: cisplatin, gemcitabine<br>* cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | 36months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 6 weeks |