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Alliance A211401


Recruiting | Phase III

Official Title:

Reducing surgical complications in newly diagnosed lung cancer patients who smoke cigarettes.

Study Purpose:

The purpose of this study is to see if complications after sugery can be reduced by helping patients stop smoking with a drug called varenicline (also called chantix) and using National Cancer Institute (NCI) Tobacco Quitline for counseling. This study will see how well the drug varenicline helps patients stop smoking by comparing it to a placebo (a pill that contains no active drug).


  • Group 1 will receive varenicline every day and access to the NCI Quitline for 12 weeks.
  • Group 2 will receive placebo every day and access to the NCI Quitline for 12 weeks.
  • Patients will also be under observation for 24 weeks following surgery.  
  • Quality of Life questionnaires (Questions to better understand how your treatment is effecting how you feel).

Patients will continue to have access to the NCI Tobacco Quitline after finishing participation in this study.   

Key Participation Requirements:


Male or Female


19 years and older


Newly diagnosed or suspected lung cancer and have sought a surgical consult relating to this diagnosis.


Surgery scheduled no sooner than 10 days after, and no more than 12 weeks after starting the study.

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.

Motivated to stop smoking. 

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Alliance A211401

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!