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


Last updated date
Study Location
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204, United States


Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center


By email


[email protected]

Call Now

Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Carcinoma
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years


Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center


[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.


Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Lung CarcinomaManagement of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
  1. Denver, Colorado
  2. Englewood, Colorado
  3. Gainesville, Florida
  4. Atlanta, Georgia
  5. Michigan City, Indiana
  6. Flint, Michigan
  7. Flint, Michigan
  8. Flint, Michigan
  9. Macomb, Michigan
  10. Farmington, Missouri
  11. Henderson, Nevada
  12. Henderson, Nevada
  13. Las Vegas, Nevada
  14. Las Vegas, Nevada
  15. Las Vegas, Nevada
  16. Las Vegas, Nevada
  17. Las Vegas, Nevada
  18. Flemington, New Jersey
  19. Philadelphia, Pennsylvania
  20. Charleston, South Carolina
  21. American Fork, Utah
  22. Cedar City, Utah
  23. Logan, Utah
  24. Murray, Utah
  25. Ogden, Utah
  26. Provo, Utah
  27. Riverton, Utah
  28. Saint George, Utah
  29. Salt Lake City, Utah
  30. Salt Lake City, Utah
  31. Tacoma, Washington
  32. Fairbanks, Alaska
  33. Kingman, Arizona
  34. Jonesboro, Arkansas
  35. Arroyo Grande, California
  36. Loma Linda, California
  37. Rancho Mirage, California
  38. Saint Helena, California
  39. Aurora, Colorado
  40. Aurora, Colorado
  41. Aurora, Colorado
  42. Boulder, Colorado
  43. Boulder, Colorado
  44. Colorado Springs, Colorado
  45. Colorado Springs, Colorado
  46. Denver, Colorado
  47. Denver, Colorado
  48. Denver, Colorado
  49. Denver, Colorado
  50. Denver, Colorado
  51. Denver, Colorado
  52. Denver, Colorado
  53. Denver, Colorado
  54. Denver, Colorado
  55. Englewood, Colorado
  56. Grand Junction, Colorado
  57. Greeley, Colorado
  58. Lafayette, Colorado
  59. Littleton, Colorado
  60. Lone Tree, Colorado
  61. Lone Tree, Colorado
  62. Loveland, Colorado
  63. Thornton, Colorado
  64. Wheat Ridge, Colorado
  65. West Haven, Connecticut
  66. Fort Lauderdale, Florida
  67. Hollywood, Florida
  68. Pembroke Pines, Florida
  69. Vero Beach, Florida
  70. Savannah, Georgia
  71. Savannah, Georgia
  72. Boise, Idaho
  73. Caldwell, Idaho
  74. Coeur d'Alene, Idaho
  75. Emmett, Idaho
  76. Meridian, Idaho
  77. Nampa, Idaho
  78. Post Falls, Idaho
  79. Sandpoint, Idaho
  80. Arlington Heights, Illinois
  81. Aurora, Illinois
  82. Bloomington, Illinois
  83. Canton, Illinois
  84. Carbondale, Illinois
  85. Carterville, Illinois
  86. Carthage, Illinois
  87. Centralia, Illinois
  88. Chicago, Illinois
  89. Chicago, Illinois
  90. Danville, Illinois
  91. Decatur, Illinois
  92. Decatur, Illinois
  93. Dixon, Illinois
  94. Effingham, Illinois
  95. Effingham, Illinois
  96. Eureka, Illinois
  97. Galesburg, Illinois
  98. Galesburg, Illinois
  99. Kewanee, Illinois
  100. Macomb, Illinois
  101. Mattoon, Illinois
  102. Maywood, Illinois
  103. Melrose Park, Illinois
  104. Moline, Illinois
  105. Ottawa, Illinois
  106. Pekin, Illinois
  107. Pekin, Illinois
  108. Peoria, Illinois
  109. Peoria, Illinois
  110. Peoria, Illinois
  111. Peoria, Illinois
  112. Peru, Illinois
  113. Peru, Illinois
  114. Princeton, Illinois
  115. Springfield, Illinois
  116. Springfield, Illinois
  117. Springfield, Illinois
  118. Swansea, Illinois
  119. Swansea, Illinois
  120. Urbana, Illinois
  121. Urbana, Illinois
  122. Yorkville, Illinois
  123. Evansville, Indiana
  124. Fort Wayne, Indiana
  125. Fort Wayne, Indiana
  126. Indianapolis, Indiana
  127. Mooresville, Indiana
  128. Newburgh, Indiana
  129. Richmond, Indiana
  130. South Bend, Indiana
  131. Corbin, Kentucky
  132. Lexington, Kentucky
  133. Louisville, Kentucky
  134. Madisonville, Kentucky
  135. Paducah, Kentucky
  136. Baton Rouge, Louisiana
  137. Baton Rouge, Louisiana
  138. Baton Rouge, Louisiana
  139. New Orleans, Louisiana
  140. Bangor, Maine
  141. Brewer, Maine
  142. Bel Air, Maryland
  143. Springfield, Massachusetts
  144. Ann Arbor, Michigan
  145. Ann Arbor, Michigan
  146. Brighton, Michigan
  147. Brighton, Michigan
  148. Canton, Michigan
  149. Canton, Michigan
  150. Caro, Michigan
  151. Chelsea, Michigan
  152. Chelsea, Michigan
  153. Clarkston, Michigan
  154. Clarkston, Michigan
  155. Detroit, Michigan
  156. East China Township, Michigan
  157. Flint, Michigan
  158. Grosse Pointe Woods, Michigan
  159. Grosse Pointe Woods, Michigan
  160. Grosse Pointe Woods, Michigan
  161. Lansing, Michigan
  162. Livonia, Michigan
  163. Livonia, Michigan
  164. Macomb, Michigan
  165. Marlette, Michigan
  166. Marquette, Michigan
  167. Marquette, Michigan
  168. Pontiac, Michigan
  169. Pontiac, Michigan
  170. Pontiac, Michigan
  171. Pontiac, Michigan
  172. Rochester Hills, Michigan
  173. Saginaw, Michigan
  174. Saginaw, Michigan
  175. Sterling Heights, Michigan
  176. Tawas City, Michigan
  177. Warren, Michigan
  178. Warren, Michigan
  179. Warren, Michigan
  180. Warren, Michigan
  181. West Branch, Michigan
  182. Ypsilanti, Michigan
  183. Ypsilanti, Michigan
  184. Mankato, Minnesota
  185. Rochester, Minnesota
  186. Saint Cloud, Minnesota
  187. Columbus, Mississippi
  188. Jackson, Mississippi
  189. New Albany, Mississippi
  190. Oxford, Mississippi
  191. Pascagoula, Mississippi
  192. Southhaven, Mississippi
  193. Bonne Terre, Missouri
  194. Cape Girardeau, Missouri
  195. Cape Girardeau, Missouri
  196. Jefferson City, Missouri
  197. Saint Louis, Missouri
  198. Sainte Genevieve, Missouri
  199. Sullivan, Missouri
  200. Sunset Hills, Missouri
  201. Anaconda, Montana
  202. Billings, Montana
  203. Bozeman, Montana
  204. Butte, Montana
  205. Great Falls, Montana
  206. Great Falls, Montana
  207. Kalispell, Montana
  208. Missoula, Montana
  209. Omaha, Nebraska
  210. Carson City, Nevada
  211. Henderson, Nevada
  212. Henderson, Nevada
  213. Henderson, Nevada
  214. Henderson, Nevada
  215. Henderson, Nevada
  216. Henderson, Nevada
  217. Henderson, Nevada
  218. Henderson, Nevada
  219. Las Vegas, Nevada
  220. Las Vegas, Nevada
  221. Las Vegas, Nevada
  222. Las Vegas, Nevada
  223. Las Vegas, Nevada
  224. Las Vegas, Nevada
  225. Las Vegas, Nevada
  226. Las Vegas, Nevada
  227. Las Vegas, Nevada
  228. Las Vegas, Nevada
  229. Las Vegas, Nevada
  230. Las Vegas, Nevada
  231. Las Vegas, Nevada
  232. Las Vegas, Nevada
  233. Las Vegas, Nevada
  234. Las Vegas, Nevada
  235. Las Vegas, Nevada
  236. Las Vegas, Nevada
  237. Las Vegas, Nevada
  238. Las Vegas, Nevada
  239. Las Vegas, Nevada
  240. Las Vegas, Nevada
  241. Las Vegas, Nevada
  242. Las Vegas, Nevada
  243. Las Vegas, Nevada
  244. Las Vegas, Nevada
  245. Las Vegas, Nevada
  246. Las Vegas, Nevada
  247. Las Vegas, Nevada
  248. Las Vegas, Nevada
  249. Las Vegas, Nevada
  250. Pahrump, Nevada
  251. Reno, Nevada
  252. Reno, Nevada
  253. Reno, Nevada
  254. Lebanon, New Hampshire
  255. Brick, New Jersey
  256. Hamilton, New Jersey
  257. Holmdel, New Jersey
  258. Manahawkin, New Jersey
  259. Mount Holly, New Jersey
  260. Neptune, New Jersey
  261. Red Bank, New Jersey
  262. Somerville, New Jersey
  263. Voorhees, New Jersey
  264. Glens Falls, New York
  265. New York, New York
  266. Poughkeepsie, New York
  267. Rochester, New York
  268. Greenville, North Carolina
  269. Alliance, Ohio
  270. Beavercreek, Ohio
  271. Boardman, Ohio
  272. Canton, Ohio
  273. Centerville, Ohio
  274. Centerville, Ohio
  275. Cincinnati, Ohio
  276. Dayton, Ohio
  277. Dayton, Ohio
  278. Dayton, Ohio
  279. Dayton, Ohio
  280. Findlay, Ohio
  281. Findlay, Ohio
  282. Findlay, Ohio
  283. Franklin, Ohio
  284. Franklin, Ohio
  285. Greenville, Ohio
  286. Greenville, Ohio
  287. Kettering, Ohio
  288. Kettering, Ohio
  289. Kettering, Ohio
  290. Springfield, Ohio
  291. Springfield, Ohio
  292. Troy, Ohio
  293. Troy, Ohio
  294. Warren, Ohio
  295. Youngstown, Ohio
  296. Oklahoma City, Oklahoma
  297. Tulsa, Oklahoma
  298. Baker City, Oregon
  299. Ontario, Oregon
  300. Allentown, Pennsylvania
  301. Bethlehem, Pennsylvania
  302. Danville, Pennsylvania
  303. East Stroudsburg, Pennsylvania
  304. Hazleton, Pennsylvania
  305. Hazleton, Pennsylvania
  306. Lewisburg, Pennsylvania
  307. Lewistown, Pennsylvania
  308. Philadelphia, Pennsylvania
  309. Pottsville, Pennsylvania
  310. Scranton, Pennsylvania
  311. Selinsgrove, Pennsylvania
  312. State College, Pennsylvania
  313. Wilkes-Barre, Pennsylvania
  314. Clinton, South Carolina
  315. Easley, South Carolina
  316. Greenville, South Carolina
  317. Greenville, South Carolina
  318. Greenville, South Carolina
  319. Greenville, South Carolina
  320. Greer, South Carolina
  321. Seneca, South Carolina
  322. Spartanburg, South Carolina
  323. Memphis, Tennessee
  324. Memphis, Tennessee
  325. Dallas, Texas
  326. Galveston, Texas
  327. League City, Texas
  328. Berlin, Vermont
  329. Burlington, Vermont
  330. Burlington, Vermont
  331. Charlottesville, Virginia
  332. Charlottesville, Virginia
  333. Fishersville, Virginia
  334. Norfolk, Virginia
  335. Auburn, Washington
  336. Bainbridge Island, Washington
  337. Bellevue, Washington
  338. Federal Way, Washington
  339. Gig Harbor, Washington
  340. Gig Harbor, Washington
  341. Kennewick, Washington
  342. Lynnwood, Washington
  343. Port Townsend, Washington
  344. Poulsbo, Washington
  345. Puyallup, Washington
  346. Puyallup, Washington
  347. Renton, Washington
  348. Seattle, Washington
  349. Spokane Valley, Washington
  350. Spokane, Washington
  351. Spokane, Washington
  352. Tacoma, Washington
  353. Tacoma, Washington
  354. Tacoma, Washington
  355. Yakima, Washington
  356. La Crosse, Wisconsin
  357. Milwaukee, Wisconsin
  358. Cheyenne, Wyoming
  359. Cody, Wyoming
  360. Sheridan, Wyoming
18 Years+
Advanced Information
Descriptive Information
Brief Title  ICMJE Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Official Title  ICMJE Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
Brief Summary 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.
Detailed Description


I. To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.


I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention (varenicline) and control group (placebo).

II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.

III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse ("Was It Worth It") each treatment (intervention versus [vs] control groups).

IV. To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups.

V. To compare treatment adherence between the intervention and control groups. VI. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Lung Carcinoma
Intervention  ICMJE
  • Drug: Varenicline
    Given PO
  • Drug: Placebo
    Given PO
  • Other: Tobacco Cessation Counseling
    Complete counseling session
Study Arms  ICMJE
  • Experimental: Intervention group (varenicline and behavioral intervention)
    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.
    • Drug: Varenicline
    • Other: Tobacco Cessation Counseling
  • Placebo Comparator: Control group (placebo and behavioral intervention)
    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.
    • Drug: Placebo
    • Other: Tobacco Cessation Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 19, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2016)
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
  • Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation Ladder
  • Within the 30 days before registration, no use of: 1) any pharmacologic treatment for smoking cessation, including bupropion or nicotine replacement therapy; 2) any nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in any formal behavioral treatment program for tobacco dependence as determined by patient report
  • No allergies to and not currently using varenicline
  • No suicidal thoughts as indicated by a positive (1+) response to the PHQ9
  • No active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression)
  • Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only

    * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

  • No unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
  • No history of seizures
  • No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic disease
  • Not currently on renal dialysis or has a history of significant renal impairment
  • No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:

    • If male, drinking > 14 alcoholic beverages per week for past 1 month
    • If female, drinking > 7 alcoholic beverages per week for past 1 month
    • Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine (MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., lysergic acid diethylamide [LSD]) at any time during the past 1 month
    • Use of marijuana on a weekly basis for the past 1 month
  • Patients must be able to complete study questionnaires in English
  • No other household member or relative participating in the study
  • No known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
  • Calculated creatinine clearance >= 30 mL/min * For females, use 85% of calculated creatinine clearance (CrCl) value
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02856581
Other Study ID Numbers  ICMJE A211401
NCI-2016-00438 ( Registry Identifier: NCI Clinical Trial Reporting Program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Study Chair:Ivana Croghan, PhDMayo
PRS Account Alliance for Clinical Trials in Oncology
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP