A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)

Study Overview
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Brief Summary
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Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).

Official Title
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A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: carboplatin
* Radiation: thoracic radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven non-small cell lung cancer (non-squamous cell carcinoma) Presence of measurable disease by RECIST Inoperable stage IIIA or IIIB ECOG performance status 0-1 No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. Exclusion Criteria: Carcinoid tumor, small cell carcinoma of lung Patients with any distant metastasis History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women Women and men of childbearing potential who have no willing of employing adequate contraception

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients receiving pemetrexed, carboplatin and radiation therapy. | Drug: pemetrexed<br>* 500 mg/m2, IV, q 21 days x 2 cycles<br>Drug: carboplatin<br>* AUC=5,IV,q 21 days x 2 cycles<br>Radiation: thoracic radiation<br>* 66 Gy over 33 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response rate |  | Tumor assessments after completion of chemoradiotherapy and every 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | baseline to date of death from any cause | 
| time to progressive disease |  | baseline to measured progressive disease | 
| the safety profile |  | every cycle | 
| site of first failure in patients who develop progressive disease |  | baseline to measured progressive disease | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, pemetrexed, radiation