Carcinoma, Non-Small Cell Lung
Conditions
Brief summary
In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.
Interventions
DRUGpemetrexed
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of NSCLC * Locally advanced or metastatic disease (Stage IIIB or IV). * Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease. * Disease status must be that of measurable disease as defined by RECIST criteria * Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.
Exclusion criteria
* Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment * Concurrent administration of any other tumor therapy. * History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study * Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. * Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate according to RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| o Duration of overall response for responding patients | — |
| o Time to progressive disease | — |
| To assess the following time to event efficacy variables: | — |
| o Survival | — |
| To characterize the quantitative and qualitative toxicity of pemetrexed when used at tailored dosing in this patient population | — |
| o Time to treatment failure | — |
Countries
Australia, China, Egypt, India, Romania, South Korea, Taiwan, Turkey (Türkiye)
Outcome results
None listed