Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer


Last updated date
Study Location
Pfizer Investigational Site
Litchfield Park, Arizona, 85340, 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.
Non-Small Cell Lung Carcinoma
Females and Males
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

- Locally advanced or metastatic NSCLC

- Measurable disease

- ECOG PS 0 or 1

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

- Known CNS metastasis

- Pre-existing autoimmune or antibody mediated disease


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

Pfizer Clinical Trials Contact Center


[email protected]


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

Non-Small Cell Lung CarcinomaA Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
  1. Florence, Alabama
  2. Muscle Shoals, Alabama
  3. Scottsdale, Arizona
  4. Hot Springs, Arkansas
  5. Antioch, California
  6. Burbank, California
  7. Downey, California
  8. Fresno, California
  9. La Jolla, California
  10. La Jolla, California
  11. Montebello, California
  12. Pleasant Hill, California
  13. San Diego, California
  14. San Leandro, California
  15. Whittier, California
  16. Fairfield, Connecticut
  17. Brooksville, Florida
  18. Cocoa Beach, Florida
  19. Fort Lauderdale, Florida
  20. Merritt Island, Florida
  21. Rockledge, Florida
  22. Titusville, Florida
  23. Athens, Georgia
  24. Aurora, Illinois
  25. Goshen, Indiana
  26. Indianapolis, Indiana
  27. Council Bluffs, Iowa
  28. Baton Rouge, Louisiana
  29. Lafayette, Louisiana
  30. Bethesda, Maryland
  31. Ann Arbor, Michigan
  32. Troy, Michigan
  33. Columbus, Mississippi
  34. Corinth, Mississippi
  35. Tupelo, Mississippi
  36. St. Louis, Missouri
  37. St. Peters, Missouri
  38. Omaha, Nebraska
  39. Las Vegas, Nevada
  40. Las Vegas, Nevada
  41. Jamaica, New York
  42. Norman, Oklahoma
  43. Oklahoma City, Oklahoma
  44. Oklahoma City, Oklahoma
  45. Oklahoma City, Oklahoma
  46. Tulsa, Oklahoma
  47. Tulsa, Oklahoma
  48. Tulsa, Oklahoma
  49. Lancaster, Pennsylvania
  50. Knoxville, Tennessee
  51. Beaumont, Texas
  52. Dallas, Texas
  53. Grapevine, Texas
  54. Irving, Texas
  55. Bountiful, Utah
  56. Layton, Utah
  57. Murray, Utah
  58. Provo, Utah
  59. Salt Lake City, Utah
  60. Salt Lake City, Utah
  61. Sandy, Utah
  62. West Valley, Utah
  63. Kennewick, Washington
  64. Buenos Aires, Capital Federal
  65. Ciudad Autonoma de Buenos Aires, Capital Federal
  66. Buenos Aires,
  67. Cordoba,
  68. Grimmenstein,
  69. Innsbruck,
  70. Linz,
  71. Bruxelles,
  72. Leuven,
  73. Liege,
  74. Rio de Janeiro, RJ
  75. Rio de Janeiro, RJ
  76. Porto Alegre, RS
  77. Barretos, SP
  78. Sao Paulo, SP
  79. Kingston, Ontario
  80. Kingston, Ontario
  81. Oshawa, Ontario
  82. Toronto, Ontario
  83. Toronto, Ontario
  84. Greenfield Park, Quebec
  85. Levis, Quebec
  86. Rimouski, Quebec
  87. Saskatoon, Saskatchewan
  88. Quebec,
  89. Independencia, Santiago, RM
  90. Providencia, Santiago, RM
  91. Santiago,
  92. Medellin, Antioquia
  93. Medellin, Antioquia
  94. Ceske Budejovice,
  95. Nova Ves pod Plesi,
  96. Olomouc,
  97. Ostrava-Poruba,
  98. Praha 2,
  99. Praha 8,
  100. Pribram V,
  101. Tabor,
  102. Usti nad Labem,
  103. Herlev,
  104. Hilleroed,
  105. Koebenhavn OE,
  106. Odense,
  107. Bad Berka,
  108. Berlin,
  109. Dresden,
  110. Ebensfeld,
  111. Essen,
  112. Gauting,
  113. Grosshansdorf,
  114. Halle (Saale),
  115. Heidelberg,
  116. Homburg,
  117. Mainz,
  118. Tuebingen,
  119. Wiesbaden,
  120. Heraklion, Crete
  121. Alexandroupoli,
  122. Athens,
  123. Kifisia, Athens,
  124. Kowloon,
  125. Shatin, NT,
  126. Tuen Mun,,
  127. Budapest,
  128. Deszk,
  129. Gyula,
  130. Matrahaza,
  131. Szekesfehervar,
  132. Zalaegerszeg-Pozva,
  133. Catania,
  134. Grosseto,
  135. Mantova,
  136. Milano,
  137. Milano,
  138. Monza (MI),
  139. Novara,
  140. Orbassano (TO),
  141. Parma,
  142. Roma,
  143. Rozzano (MI),
  144. Seoul,
  145. Seoul,
  146. Seoul,
  147. Seoul,
  148. Enschede, Ov
  149. 's-Hertogenbosch,
  150. Amsterdam,
  151. Arnhem,
  152. Harderwijk,
  153. Maastricht,
  154. Rotterdam,
  155. Rotterdam,
  156. Kristiansand S,
  157. Oslo,
  158. Stavanger,
  159. Tromso,
  160. Trondheim,
  161. Lodz,
  162. Opole,
  163. Otwock,
  164. Warszawa,
  165. Warszawa,
  166. Zielona Gora,
  167. Moscow,
  168. Moscow,
  169. St-Petersburg,
  170. St. Petersburg,
  171. Bratislava,
  172. Kosice,
  173. Kvetnica pri Poprade,
  174. Nitra-Zobor,
  175. Zilina,
  176. Sabadell, Barcelona
  177. Palma de Mallorca, Islas Baleares
  178. La Laguna, Santa Cruz de Tenerife
  179. Dos Hermanas, Sevilla
  180. Barcelona,
  181. La Coruña,
  182. Madrid,
  183. Malaga,
  184. Sevilla,
  185. Valencia,
  186. Genolier,
  187. Gwei Shan Township, Taoyuan County
  188. Taichung,
  189. Tainan,
  190. Pathumwan, Bangkok
  191. Amphoe Mueang, Chiang Mai
  192. Bangkok,
  193. Bebington, Wirral,
  194. Cambridge,
  195. Derby,
  196. Dundee,
  197. Keighley, West Yorkshire,
  198. London,
  199. London,
  200. Peterborough,
  201. Rhyl, Denbigshire,
  202. Sheffield,
  203. Southampton,
  204. Yeovil, Somerset,
18 Years+
Non-Small Cell Lung CarcinomaTrial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
  1. Litchfield Park, Arizona
  2. Sun City, Arizona
  3. Bentonville, Arkansas
  4. Fayetteville, Arkansas
  5. Hudson, Florida
  6. New Port Richey, Florida
  7. Mahwah, New Jersey
  8. Midland Park, New Jersey
  9. Paramus, New Jersey
  10. Westwood, New Jersey
  11. Oneida, New York
  12. Oswego, New York
  13. Syracuse, New York
  14. Syracuse, New York
  15. Sylvania, Ohio
  16. Seattle, Washington
  17. Seattle, Washington
  18. Grosshansdorf,
  19. Mannheim,
  20. Torino,
18 Years+
Non-Small Cell Lung CarcinomaPH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
  1. Tampa, Florida
  2. Park Ridge, Illinois
  3. Skokie, Illinois
  4. Louisville, Kentucky
  5. Louisville, Kentucky
  6. Houston, Texas
  7. Hamilton, Ontario
18 Years+
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease
Brief Summary To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
Detailed Description PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • Drug: pemetrexed
    500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
    Other Name: Alimta
  • Drug: pemetrexed + PF-3512676
    pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
    Other Name: Alimta
Study Arms  ICMJE
  • Active Comparator: B
    Standard of care chemotherapy
    Intervention: Drug: pemetrexed
  • Experimental: A
    Standard of care chemotherapy plus experimental intervention (PF-3512676)
    Intervention: Drug: pemetrexed + PF-3512676
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 Terminated
Actual Enrollment  ICMJE
 (submitted: December 11, 2008)
Original Enrollment  ICMJE
 (submitted: May 2, 2006)
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Locally advanced or metastatic NSCLC
  • Measurable disease
  • ECOG PS 0 or 1

Exclusion Criteria:

  • Known CNS metastasis
  • Pre-existing autoimmune or antibody mediated disease
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 Germany,   Italy,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00321308
Other Study ID Numbers  ICMJE A8501004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date September 2009

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