Stanley 1986

Methods	International randomised multicenter trial
Participants	Number of participants: 441 (February 1979 to October 1981) Number randomised: Experimental group (BCG + Isoniazid): Not specified in the report Control group (Saline): Not specified in the report. Number evaluated: Experimental group: 198, age: < 70 years Control group: 209, age: < 70 years Diagnosis: Patients with a completely resected stage I and stage II non‐small cell bronchogenic carcinoma. Inclusions: eligible patients should: This trial included only those patients with a resected non‐small cell carcinoma pT1N0M0, pT2N0M0, pT1N1M0, or pT2N1M0 (Stages I and 11). Patients < 70 years of age, and those without history of previous malignancy, radiotherapy, chemotherapy, or immunosuppressive treatment.
Interventions	Experimental group : A single dose of 1 X 10⁷ units of BCG Tice were given into the pleural space between day 6 and day 12 postoperatively. Isoniazid (INH) 300 mg/day by mouth, starting on the 14th post‐injection day and continuing for 12 weeks. Control group: 35 cc. of saline injected through the pleural catheter and no INH was given.
Outcomes	Duration of follow‐up (median): 4.7 years Disease‐free interval, overall survival, adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Had placebo comparator without detailed explanation of blinding of participants or researchers
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	407 randomised participants were included in analysis (90.8%)
Selective reporting (reporting bias)	High risk	No protocol was available, and no pre‐specified primary outcome was reported.
Other bias	Low risk	No obvious potential source of bias