A Study to Diagnose Lung Cancer by Sputum Cytology (01-312)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Lung Cancer

Treatments

Drug: Uridine 5'-Triphosphate (UTP) Solution for Inhalation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210080

01-312

Details and patient eligibility

About

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.

Sex

Volunteers

No Healthy Volunteers

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