Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Detailed Description
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This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.

Official Title
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A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib (Tarceva)
* Drug: Pemetrexed (Alimta)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma Stage IIIB/IV Failure to prior chemotherapy Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated Absence or irradiated and stable central nervous system metastatic disease. Life expectancy of more than 3 months Tissue sample desired for genomic study Age ≥ 18 years Performance status (WHO) < 3 For patients > 65 years old: non-frail according to comprehensive geriatric assessment Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3) Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl) Presence of a reliable care giver for patients > 65 years old Informed consent. Exclusion Criteria: Psychiatric illness or social situation that would preclude study compliance Other concurrent uncontrolled illness Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: 1<br>Alimta | Drug: Pemetrexed (Alimta)<br>* Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles<br>* Other names: Alimta;|
| Experimental: 2<br>Tarceva | Drug: Erlotinib (Tarceva)<br>* Erlotinib at the dose of 150 mg orally once a day continually until progression<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression |  | 1 year TTP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) | 
| Overall survival between the two treatment arms |  | 1 year OS | 
| Quality of life assessment |  | Assessment every two cycles | 
| Toxicity profile between the two treatment arms |  | Toxicity assessment on each chemotherapy cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Non-small-cell lung cancer, Chemotherapy, Pemetrexed, Erlotinib