RATIONALE: Doctors can diagnose lung cancer by collecting mucus coughed up from the lungs
and examining it under a microscope to look for cancer cells. Breathing in INS316 may make
it easier for patients to cough up mucus.
PURPOSE: Randomized phase II trial to study the effectiveness of INS316 in helping to
diagnose lung cancer.
OBJECTIVES: I. Determine whether a cytological diagnosis of lung cancer can be obtained more
frequently from sputum specimens following inhalation of INS316 compared to specimens
obtained following placebo or compared to specimens spontaneously expectorated in patients
with untreated lung cancer. II. Assess the relative sensitivity of sputum cytology in the
diagnosis of lung malignancies in this patient population using these sputum collection
regimens. III. Determine the quantity of macrophages in sputum of these patients using these
techniques. IV. Determine if the number of macrophages in sputum obtained by these methods
is predictive of the likelihood of obtaining a positive diagnosis of lung cancer in these
patients. V. Determine the total amount of sputum expectorated from these patients using
OUTLINE: This is a randomized, double-blind, placebo-controlled, cross-over, multicenter
study. Patients are randomized to one of two arms, then cross-over to the other arm. Arm I:
Patients receive INS316 by inhalation via a nebulizer. Sputum is collected throughout the
dosing and for 1 hour post dosing. Arm II: Patients receive placebo in the same manner as
INS136 in arm I. All patients receive both treatments. Patients receive the first dose no
more than 7 days after screening, and the second dose 3 to 10 days after the first dose.
Patients are followed 1 day after completion of the second treatment. The sputum samples are
fixed and examined cytologically.
PROJECTED ACCRUAL: Approximately 100-130 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically or cytologically proven primary lung cancer OR
Presumptive diagnosis based on chest x-ray, CT scan, history, or symptoms No prior
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Pulmonary: FEV1 at least 35% predicted Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No other comorbid
condition that would preclude study
PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 days since prior
bronchoscopic examination or pulmonary fine needle aspiration biopsy At least 3 days since
prior sputum induction No concurrent medication that would preclude study At least 30 days
since prior investigational drugs (including INS316) or experimental therapy