Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGpemetrexed with bevacizumab
Sponsors
Kobe City General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | Within the study period and until tumor proression, an expected average of 16 weeks |
Secondary
| Measure | 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 |
Countries
Japan
Outcome results
None listed