A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Back to Search
Print
Bookmark Trial

NCT00265317

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with locally advanced/metastatic non-small cell lung cancer

- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial
growth factor (VEGF) inhibitors or other angiogenic inhibitors


- History of or known brain metastases

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

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.

Advanced Search

Based on your search, you may also be interested in

Non-Small-Cell Lung CarcinomaMEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer
NCT00174369
  1. Greenbrae, California
  2. La Jolla, California
  3. LaJolla, California
  4. San Diego, California
  5. San Mateo, California
  6. Tampa, Florida
  7. Ann Arbor, Michigan
  8. Detroit, Michigan
  9. Farmington Hills, Michigan
  10. Coon Rapids, Minnesota
  11. Fridley, Minnesota
  12. Robbinsdale, Minnesota
  13. New York, New York
  14. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small-Cell Lung CarcinomaStudy Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
NCT00092001
  1. Baltimore, Maryland
  2. St. Louis, Missouri
  3. St. Louis, Missouri
  4. St. Peters, Missouri
  5. Chapel Hill, North Carolina
  6. Clinton, North Carolina
  7. Goldsboro, North Carolina
  8. Pollocksville, North Carolina
  9. Wilson, North Carolina
  10. Pittsburgh, Pennsylvania
  11. Charlottesville, Virginia
  12. Orbassano (Torino),
  13. Badalona, Barcelona
  14. Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small-Cell Lung CarcinomaAn Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
NCT00932451
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Little Rock, Arkansas
  4. Bakersfield, California
  5. Beverly Hills, California
  6. Beverly Hills, California
  7. La Jolla, California
  8. La Jolla, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Orange, California
  14. Orange, California
  15. Palo Alto, California
  16. Sacramento, California
  17. Sacramento, California
  18. San Diego, California
  19. Santa Monica, California
  20. Santa Monica, California
  21. Santa Monica, California
  22. Santa Rosa, California
  23. Aurora, Colorado
  24. Aurora, Colorado
  25. Aurora, Colorado
  26. Denver, Colorado
  27. Lafayette, Colorado
  28. New Haven, Connecticut
  29. New Haven, Connecticut
  30. New Haven, Connecticut
  31. Fort Lauderdale, Florida
  32. Hollywood, Florida
  33. Lake Worth, Florida
  34. Pembroke Pines, Florida
  35. Tampa, Florida
  36. Atlanta, Georgia
  37. Atlanta, Georgia
  38. Atlanta, Georgia
  39. Atlanta, Georgia
  40. Atlanta, Georgia
  41. Atlanta, Georgia
  42. Augusta, Georgia
  43. Augusta, Georgia
  44. Augusta, Georgia
  45. Decatur, Georgia
  46. Macon, Georgia
  47. Marietta, Georgia
  48. Sandy Springs, Georgia
  49. Honolulu, Hawaii
  50. Honolulu, Hawaii
  51. Honolulu, Hawaii
  52. Chicago, Illinois
  53. Chicago, Illinois
  54. Chicago, Illinois
  55. Harvey, Illinois
  56. Harvey, Illinois
  57. Harvey, Illinois
  58. Tinley Park, Illinois
  59. Indianapolis, Indiana
  60. Indianapolis, Indiana
  61. Indianapolis, Indiana
  62. Indianapolis, Indiana
  63. Indianopolis, Indiana
  64. Munster, Indiana
  65. Munster, Indiana
  66. Baltimore, Maryland
  67. Baltimore, Maryland
  68. Bethesda, Maryland
  69. Boston, Massachusetts
  70. Boston, Massachusetts
  71. Boston, Massachusetts
  72. Boston, Massachusetts
  73. Boston, Massachusetts
  74. Boston, Massachusetts
  75. Boston, Massachusetts
  76. Detroit, Michigan
  77. Farmington Hills, Michigan
  78. St. Louis, Missouri
  79. St. Louis, Missouri
  80. St. Peters, Missouri
  81. Omaha, Nebraska
  82. Lebanon, New Hampshire
  83. Albuquerque, New Mexico
  84. Albuquerque, New Mexico
  85. Lake Success, New York
  86. Manhasset, New York
  87. New Hyde Park, New York
  88. New York, New York
  89. New York, New York
  90. New York, New York
  91. New York, New York
  92. Oneida, New York
  93. Oswego, New York
  94. Syracuse, New York
  95. Syracuse, New York
  96. Chapel Hill, North Carolina
  97. Chapel Hill, North Carolina
  98. Charlotte, North Carolina
  99. Huntersville, North Carolina
  100. Huntersville, North Carolina
  101. Matthews, North Carolina
  102. Cleveland, Ohio
  103. Columbus, Ohio
  104. Columbus, Ohio
  105. Columbus, Ohio
  106. Columbus, Ohio
  107. Portland, Oregon
  108. Hershey, Pennsylvania
  109. Philadelphia, Pennsylvania
  110. Philadelphia, Pennsylvania
  111. Philadelphia, Pennsylvania
  112. Pittsburgh, Pennsylvania
  113. East Providence, Rhode Island
  114. East Providence, Rhode Island
  115. Charleston, South Carolina
  116. Dickson, Tennessee
  117. Franklin, Tennessee
  118. Gallatin, Tennessee
  119. Hermitage, Tennessee
  120. Lebanon, Tennessee
  121. Murfreesboro, Tennessee
  122. Nashville, Tennessee
  123. Nashville, Tennessee
  124. Nashville, Tennessee
  125. Nashville, Tennessee
  126. Nashville, Tennessee
  127. Nashville, Tennessee
  128. Nashville, Tennessee
  129. Nashville, Tennessee
  130. Smyrna, Tennessee
  131. Dallas, Texas
  132. Dallas, Texas
  133. Dallas, Texas
  134. Dallas, Texas
  135. Houston, Texas
  136. Seattle, Washington
  137. Seattle, Washington
  138. Seattle, Washington
  139. Seattle, Washington
  140. Seattle, Washington
  141. Camperdown, New South Wales
  142. Adelaide, South Australia
  143. East Melbourne, Victoria
  144. Nedlands, Western Australia
  145. Salvador, Bahia
  146. Rio de Janeiro, RJ
  147. Ijui, RS
  148. Porto Alegre, RS
  149. Porto Alegre, RS
  150. Jau, Sao Paulo
  151. Barretos, SP
  152. Sao Paulo, SP
  153. Sao Paulo, SP
  154. Sofia,
  155. Sofia,
  156. Sofia,
  157. Varna,
  158. Calgary, Alberta
  159. Calgary, Alberta
  160. Calgary, Alberta
  161. Edmonton, Alberta
  162. Moncton, New Brunswick
  163. Moncton, New Brunswick
  164. Oshawa, Ontario
  165. Oshawa, Ontario
  166. Ottawa, Ontario
  167. Montreal, Quebec
  168. Montreal, Quebec
  169. Montreal, Quebec
  170. Montreal, Quebec
  171. Montreal, Quebec
  172. Guangzhou, Guangdong
  173. Nanjing, Jiangsu
  174. Beijing,
  175. Beijing,
  176. Guangzhou,
  177. Shanghai,
  178. Shanghai,
  179. Shanghai,
  180. Shanghai,
  181. Caen Cedex 05,
  182. Dijon,
  183. Grenoble Cedex 09,
  184. Marseille Cedex 20,
  185. NICE Cedex 2,
  186. Paris cedex 20,
  187. Paris,
  188. St Herblain Cedex,
  189. Villejuif,
  190. Dresden,
  191. Essen,
  192. Grosshansdorf,
  193. Hamburg,
  194. Heidelberg,
  195. Koeln,
  196. Muenchen,
  197. Oldenburg,
  198. Wiesbaden,
  199. Heraklion, Crete
  200. Exohi, Thessaloniki
  201. Athens,
  202. Pokfulam,
  203. Shatin, New Territories,
  204. Tuen Mun, New Territories,
  205. Budapest,
  206. Budapest,
  207. Debrecen,
  208. Farkasgyepu,
  209. Szekesfehervar,
  210. Torokbalint,
  211. Dublin,
  212. Dublin,
  213. Galway,
  214. Galway,
  215. Galway,
  216. Avellino,
  217. Firenze,
  218. Genova,
  219. Lido di Camaiore (LU),
  220. Lucca,
  221. Milano,
  222. Milano,
  223. Milano,
  224. Milano,
  225. Monza,
  226. Orbassano (TO),
  227. Perugia,
  228. Roma,
  229. Torino,
  230. Nagoya, Aichi
  231. Sapporo, Hokkaido
  232. Akashi, Hyogo
  233. Osakasayama-shi, Osaka
  234. Sunto-gun, Shizuoka
  235. Chuo-ku, Tokyo
  236. Fukuoka,
  237. Kashiwa,
  238. Okayama,
  239. Tokyo,
  240. Gyeonggi-do,
  241. Seoul,
  242. Seoul,
  243. Groningen,
  244. Gdansk,
  245. Olsztyn,
  246. Olsztyn,
  247. Olsztyn,
  248. Olsztyn,
  249. Poznan,
  250. Poznan,
  251. Kazan,
  252. Moscow,
  253. Saint-Petersburg,
  254. Saint-Petersburg,
  255. Saint-Petersburg,
  256. St. Petersburg,
  257. Oviedo, Asturias
  258. Badalona, Barcelona
  259. L'hospitalet de Llobregat, Barcelona
  260. Sabadell, Barcelona
  261. A Coruña, Galicia
  262. Barcelona,
  263. Barcelona,
  264. Madrid,
  265. Pamplona,
  266. Santander,
  267. Sevilla,
  268. Stockholm,
  269. Tainan,
  270. Taipei,
  271. Taipei,
  272. Headington, Oxford
  273. Sutton, Surrey
  274. Eastleigh,
  275. London,
  276. London,
  277. London,
  278. Manchester,
  279. Southampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small-Cell Lung CarcinomaA Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
NCT00265317
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Mobile, Alabama
  4. Antioch, California
  5. Palm Springs, California
  6. Pleasant Hill, California
  7. San Leandro, California
  8. Chicago, Illinois
  9. Creve Coeur, Missouri
  10. St. Louis, Missouri
  11. St. Louis, Missouri
  12. St. Peters, Missouri
  13. Chapel Hill, North Carolina
  14. Clinton, North Carolina
  15. Goldsboro, North Carolina
  16. Wilson, North Carolina
  17. Cleveland, Ohio
  18. Houston, Texas
  19. Edmonton, Alberta
  20. Hamilton, Ontario
  21. Budapest,
  22. Torokbalint,
  23. Genova,
  24. Monteforte Irpino, AV,
  25. Amsterdam,
  26. Groningen,
  27. Bydgoszcz,
  28. Gdansk,
  29. Cluj-Napoca, Cluj
  30. Bucuresti, Sector 2
  31. Bucuresti,
  32. Santander, Cantabria
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
Official Title  ICMJE Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer
Brief Summary This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: erlotinib
    erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
  • Drug: sunitinib
    Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
    Other Name: Sutent
  • Drug: placebo
    Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: erlotinib
    • Drug: sunitinib
  • Active Comparator: B
    Interventions:
    • Drug: erlotinib
    • Drug: placebo
Publications * Groen HJ, Socinski MA, Grossi F, Juhasz E, Gridelli C, Baas P, Butts CA, Chmielowska E, Usari T, Selaru P, Harmon C, Williams JA, Gao F, Tye L, Chao RC, Blumenschein GR Jr. A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). Ann Oncol. 2013 Sep;24(9):2382-9. doi: 10.1093/annonc/mdt212. Epub 2013 Jun 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2011)		162
Original Enrollment  ICMJE
 (submitted: December 12, 2005)		136
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with locally advanced/metastatic non-small cell lung cancer
  • Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria:

  • Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  • History of or known brain metastases
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 Canada,   Hungary,   Italy,   Netherlands,   Poland,   Romania,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265317
Other Study ID Numbers  ICMJE A6181058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

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