Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Recruiting in Palo Alto (17 mi)

+373 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline \[tobacco cessation service available through a toll-free telephone number\] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

Eligibility Criteria

Inclusion Criteria

Eligible patients will have a new diagnosis of lung cancer and have sought a surgical consult relating to this diagnosis

Surgery must be scheduled no sooner than 10 days after randomization and no more than twelve weeks after randomization

Have smoked daily or nearly every day in the previous 6 months up to the date of surgical consult AND have smoked at least one puff in the previous 7 days

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Treatment Details

Interventions

Placebo (Drug)
Tobacco Cessation Counseling (Other)
Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention group (varenicline and behavioral intervention)Experimental Treatment2 Interventions

Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.

Group II: Control group (placebo and behavioral intervention)Placebo Group2 Interventions

Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.

Varenicline is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Chantix for: