The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab

Study Overview
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Brief Summary
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For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.

Official Title
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The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Conditions
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Advanced Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed with bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 Years and older PS0-2 Advanced non-squamous non-small cell lung cancer; AND Patients who have received more than 4 cycles of pemetrexed therapy before the study Exclusion Criteria: Interstitial pneumonia; AND Abnormal blood test

Ages Eligible for Study
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Minimum Age: 20 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: pemetrexed with bevacizumab<br>pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1) | Drug: pemetrexed with bevacizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | Within the study period and until tumor proression, an expected average of 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks | 
| overall survival |  | From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years | 
| time to treatment failure (TTF) |  | From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | 
| Number of Participants with Adverse Events |  | From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years |