Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified		WA-LUN-1 NOG-2177

Objectives

I.  Compare potential efficacy of immunotherapy with intrapleural BCG plus 
levamisole placebo vs. immunotherapy with combined intrapleural BCG and 
levamisole vs. BCG placebo and levamisole placebo in patients following 
resection for non-small cell carcinoma of the lung.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
squamous cell carcinoma, adenocarcinoma, or undifferentiated large cell 
carcinoma of the lung.  Patients with undifferentiated small cell (oat cell) 
carcinoma will not be included.  Lung cancer must be completely resected prior 
to entry.  Patients must have no serious concomitant disease; they must have 
adequate renal, pulmonary, and hepatic function.

Expected Enrollment

An accrual rate of approximately 70 patients per year in Strata I, II, and III 
is anticipated.  Approximately three years of patient accrual will be 
required.  Protocol closed.

Outline

Randomized, non-blind study.
All patients upon entry will be assigned to one of four strata by clinical TNM 
classification:  Stratum I (T1N0M0); Stratum II (T2N0M0 and T1N1M0); Stratum 
III (T2N1M0); and Stratum IV (T3N0M0 and T3N1M0).  Prior to Surgery, patients 
will be randomly assigned either Levamisole or Levamisole placebo.  Patients 
in Strata I, II, III, or IV who were assigned Levamisole will receive active 
BCG (Arm I); patients in Strata I or II who were assigned Levamisole placebo 
will be randomly assigned active BCG (Arm II) or BCG placebo (Arm III).
Arm I:  Surgery plus 2-Drug Immunotherapy.  BCG, unspecified, no NSC number; 
Levamisole, LEV, NSC-177023; Isoniazid, INH, NSC-9659.
Arm II:  Surgery plus Single-agent Immunotherapy.  BCG; Levamisole placebo; 
INH.
Arm III:  Control.  Surgery plus BCG/INH placebo plus LEV placebo.

Trial Contact Information

Trial Lead Organizations

Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center

Lucius Hill, MD, Protocol chair		Ph: 206-223-2374