Clinical trial · Interventional
S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery
Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and II Non-Small Cell Lung Cancer Survivors Who Are Current Smokers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was closed early due to poor accrual
Summary
Brief summary (as posted)
RATIONALE: A program that includes bupropion may be more effective in helping early-stage lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is more effective with or without bupropion. PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit smoking with or without bupropion in treating patients who have undergone surgery for stage I or stage II non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bupropion hydrochloride | Drug | — | UNRESOLVED |
| nicotine | Drug | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| smoking cessation intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Behavioral Intervention + Placebo
- description
- Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.
- interventionNames
- Behavioral: smoking cessation intervention
- Drug: nicotine
- Procedure: psychosocial assessment and care
- type
- ACTIVE_COMPARATOR
- label
- Behavioral Intervention + Bupropion
- description
- Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .
- interventionNames
- Behavioral: smoking cessation intervention
- Drug: bupropion hydrochloride
- Drug: nicotine
- Procedure: psychosocial assessment and care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage I or II non-small cell lung cancer with complete resection of all disease * Must be free of recurrent or progressive disease * Current smoker defined as: * Smoked at least 100 cigarettes in entire life AND * Currently smoking some days or every day * Must establish a quit date that falls within 30 days after registration, but 7 days after physician advice and start of bupropion or placebo therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * Not within an immediate post-infarction period * No uncontrolled arrhythmias * No unstable angina * No uncontrolled hypertension (unstable blood pressure, diastolic pressure 90 mm Hg or greater) Other: * Must be able to read, speak, and understand English * Must be willing to allow testing of saliva for cotinine levels * No history of seizures * No history of eating disorders * No known drug-drug interactions between nicotine patch and/or bupropion and patient's current or planned medications including chemotherapy and antiemetics * No concurrent psychiatric diagnosis that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Concurrent adjuvant chemotherapy allowed Endocrine therapy: * No concurrent systemic steroids Radiotherapy: * Concurrent adjuvant radiotherapy allowed Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * Prior neoadjuvant therapy allowed * At least 14 days since prior medications containing bupropion (e.g., Wellbutrin or Wellbutrin SR) * No other concurrent medications that contain bupropion (e.g., Wellbutrin or Wellbutrin SR) * No concurrent monoamine oxidase inhibitors * No concurrent medications that lower seizure threshold (e.g., antipsychotics, antidepressants, or theophylline) * No other concurrent nicotine replacement therapy
References
Publications (0)
Data not yet available