Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Advanced Non-Small Cell Lung Cancer, NSCLC
Brief summary
This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.
Interventions
DRUGMK0457
IV infusion at 10 mg/m2/hour; 5-day continuous infusion every 21 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting)
Exclusion criteria
* Patients who have had treatment with any investigational therapy within the past 30 days are not eligible. * Patients who have had a disease or medical condition that is not controlled will not be eligible. * Patients who are pregnant or breastfeeding are not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle. | 5 Days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity. | 5 Days |
Outcome results
None listed