Advanced Non-small Cell Lung Cancer Clinical Trial
Official title:
The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Verified date | August 2019 |
Source | Kobe City General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | March 20, 2019 |
Est. primary completion date | March 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Kobe City Medical Center General Hospital | Kobe | Hyogo |
Lead Sponsor | Collaborator |
---|---|
Kobe City General Hospital |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression free survival | Within the study period and until tumor proression, an expected average of 16 weeks | ||
Secondary | 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 | ||
Secondary | overall survival | From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years | ||
Secondary | 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 | ||
Secondary | 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 |
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