Lung Cancer
Conditions
Brief summary
The primary objective of this study is to determine if more diagnoses of lung cancer are obtained from the cytological evaluation of sputum expectorated following a single inhaled dose of UTP compared to sputum expectorated following a single inhaled dose of placebo in patients suspected of having lung cancer.
Interventions
DRUGUridine 5'-Triphosphate (UTP) Solution for Inhalation
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Inclusion criteria
* be suspected of having primary lung cancer based upon chest radiograph(s), CT scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of malignancy * have FEV1 greater than or equal to 40% predicted normal for age and height
Exclusion criteria
* have obtained a confirmed diagnosis for the current suspicious lung tumor * have been treated for the current, suspicious tumor except in cases in which the current lesion is the recurrence of the same tumor (same location) for which treatment was administered no less than 180 days prior to screening * have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy within 4 days prior to dosing, or have undergone sputum induction within 3 days prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of lung cancers (malignancies) diagnosed by sputum cytology | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of centrally and peripherally located lung cancers diagnosed by sputum cytology; | — |
| Proportion of small and large lung cancers diagnosed by sputum cytology; | — |
| Proportion of lung cancers of various cell types, stages and resectability diagnosed by sputum cytology; | — |
| Wet weight of sputum expectorated; | — |
| Macrophage content of sputum | — |
Outcome results
None listed