Prospective Observational Study To Identify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management (IDEALK)

NCT02679170

Last updated date
Study Location
H.U. La Paz
Madrid, , 28046, Spain
Contact
1-800-718-1021

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 Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with Advanced or metastatic non-small cell lung cancer

- Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement

- Age > 18 years

- For the patients that will be recruited prospectively: Patients must have a signed informed consent document.

- For the treatment sub-study, patients must also meet the following criteria

- Confirmed anaplastic lymphoma kinase (ALK)-positive tumour

- Patients treated with crizotinib under routine clinical practice

- Patients with a minimum data registered at the medical history

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


- Any patient who does not meet any of the inclusion criteria defined in the previous
section, depending on the sub-study for which they are included.

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]

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.

Based on your search, you may also be interested in

Non-Small Cell Lung CancerARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer NCT01360554
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Florence, Alabama
  5. Mobile, Alabama
  6. Mobile, Alabama
  7. Muscle Shoals, Alabama
  8. Chandler, Arizona
  9. Chandler, Arizona
  10. Gilbert, Arizona
  11. Mesa, Arizona
  12. Mesa, Arizona
  13. Fayetteville, Arkansas
  14. Rogers, Arkansas
  15. Alhambra, California
  16. Alhambra, California
  17. Duarte, California
  18. Fullerton, California
  19. Los Angeles, California
  20. Los Angeles, California
  21. Los Angeles, California
  22. Los Angeles, California
  23. Los Angeles, California
  24. Los Angeles, California
  25. Los Angeles, California
  26. Los Angeles, California
  27. Los Angeles, California
  28. Los Angeles, California
  29. Pasadena, California
  30. Pasadena, California
  31. Redondo Beach, California
  32. Santa Maria, California
  33. Santa Monica, California
  34. Santa Monica, California
  35. Santa Monica, California
  36. South Pasadena, California
  37. Valencia, California
  38. Westlake Village, California
  39. Norwalk, Connecticut
  40. Orlando, Florida
  41. Orlando, Florida
  42. Orlando, Florida
  43. Orlando, Florida
  44. Port Saint Lucie, Florida
  45. Atlanta, Georgia
  46. Atlanta, Georgia
  47. Atlanta, Georgia
  48. Atlanta, Georgia
  49. Austell, Georgia
  50. Carrollton, Georgia
  51. Cartersville, Georgia
  52. Columbus, Georgia
  53. Decatur, Georgia
  54. Decatur, Georgia
  55. Decatur, Georgia
  56. Douglasville, Georgia
  57. Duluth, Georgia
  58. Gainesville, Georgia
  59. Gainesville, Georgia
  60. Gainesville, Georgia
  61. Lawrenceville, Georgia
  62. Marietta, Georgia
  63. Snellville, Georgia
  64. Arlington Heights, Illinois
  65. Harvey, Illinois
  66. Harvey, Illinois
  67. Harvey, Illinois
  68. Niles, Illinois
  69. Tinley Park, Illinois
  70. Evansville, Indiana
  71. Munster, Indiana
  72. Waterloo, Iowa
  73. Hazard, Kentucky
  74. Louisville, Kentucky
  75. Louisville, Kentucky
  76. Louisville, Kentucky
  77. Detroit, Michigan
  78. Farmington Hills, Michigan
  79. Starkville, Mississippi
  80. Tupelo, Mississippi
  81. Creve Coeur, Missouri
  82. Saint Louis, Missouri
  83. Saint Louis, Missouri
  84. Saint Peters, Missouri
  85. Lebanon, New Hampshire
  86. Denville, New Jersey
  87. Stony Brook, New York
  88. Hickory, North Carolina
  89. Lenoir, North Carolina
  90. Norman, Oklahoma
  91. Oklahoma City, Oklahoma
  92. Oklahoma City, Oklahoma
  93. Corvallis, Oregon
  94. Corvallis, Oregon
  95. Corvallis, Oregon
  96. Lincoln City, Oregon
  97. Newport, Oregon
  98. Sayre, Pennsylvania
  99. Sayre, Pennsylvania
  100. Longview, Texas
  101. Tyler, Texas
  102. Waco, Texas
  103. Kennewick, Washington
  104. Richland, Washington
  105. Richland, Washington
  106. Seattle, Washington
  107. Seattle, Washington
  108. Vienna,
  109. Brussels,
  110. Brussels,
  111. Charleroi,
  112. Mons,
  113. Roeselare,
  114. Nanning, Guangxi
  115. Wuhan, Hubei
  116. Changchun, Jilin
  117. Chengdu, Sichuan
  118. Shanghai,
  119. Aalborg,
  120. Helsinki,
  121. Pori,
  122. Dijon,
  123. Grenoble cedex 09,
  124. Paris,
  125. Poitiers Cedex,
  126. Saint Herblain cedex,
  127. Aachen,
  128. Gauting,
  129. Immenhausen,
  130. Mainz,
  131. Moers,
  132. Larissa, Thessaly
  133. Athens,
  134. Heraklion,
  135. Budapest,
  136. Debrecen,
  137. Farkasgyepu,
  138. Gyula,
  139. Nyiregyhaza,
  140. Zalaegerszeg-Pozva,
  141. Ahmedabad, Gujarat
  142. Bangalore, Karnataka
  143. Mumbai, Maharashtra
  144. Pune, Maharastra
  145. Dublin, Leinster
  146. Dublin, Leinster
  147. Dublin,
  148. Waterford,
  149. Nagoya, Aichi
  150. Kashiwa, Chiba
  151. Matsuyama-city, Ehime
  152. Asahikawa, Hokkaido
  153. Akashi, Hyogo
  154. Kanazawa city, Ishikawa
  155. Yokohama, Kanagawa
  156. Sendai, Miyagi
  157. Kurashiki, Okayama
  158. Okayama-city, Okayama
  159. Sakai-Shi, Osaka-fu
  160. Osaka-city, Osaka
  161. Osakasayama-shi, Osaka
  162. Sunto-gun, Shizuoka
  163. Chuo-Ku, Tokyo
  164. Ube-shi, Yamaguchi
  165. Fukuoka,
  166. Fukuoka,
  167. Fukuoka,
  168. Koto-ku, Tokyo,
  169. Seoul,
  170. Seoul,
  171. Seoul,
  172. Oaxaca,
  173. Otwock, Mazowieckie
  174. Otwock, Mazowieckie
  175. Warsaw, Mazowieckie
  176. Warsaw, Mazowieckie
  177. Krasnodar, Krasnodarskij Kraj
  178. Sochi, Krasnodarskij Kraj
  179. Pyatigorsk, Stavropolskij Kraj
  180. Pyatigorsk,
  181. Saint-Petersburg,
  182. Saint-Petersburg,
  183. Saint-Petersburg,
  184. Saint-Petersburg,
  185. Saint-Petersburg,
  186. Saint-Petersburg,
  187. Saint-Petersburg,
  188. Samara,
  189. Bratislava,
  190. Nitra,
  191. Nove Zamky,
  192. Parktown,Johannesburg, Gauteng
  193. Kraaifontein, Western Cape
  194. Bloemfontein,
  195. Port Elizabeth,
  196. Elche, Alicante
  197. Badalona, Barcelona
  198. Castellón, Castellon
  199. Barcelona,
  200. Barcelona,
  201. Barcelona,
  202. Barcelona,
  203. Barcelona,
  204. Barcelona,
  205. Castellon,
  206. Madrid,
  207. Madrid,
  208. Madrid,
  209. Sevilla,
  210. Karlstad,
  211. Stockholm,
  212. Aarau,
  213. Bellinzona,
  214. Geneve 14,
  215. Locarno,
  216. St. Gallen,
  217. Maidstone, Kent
  218. Wolverhampton, West Midlands
  219. Edmonton,
  220. Leicester,
  221. London,
  222. Manchester,
  223. Manchester,
  224. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CancerStudy Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases NCT00372775
  1. Norwalk, Connecticut
  2. Cocoa Beach, Florida
  3. Merritt Island, Florida
  4. Titusville, Florida
  5. Creve Coeur, Missouri
  6. St. Louis, Missouri
  7. St. Louis, Missouri
  8. St. Peters, Missouri
  9. Basking Ridge, New Jersey
  10. Commack, New York
  11. New York, New York
  12. Sayre, Pennsylvania
  13. Austin, Texas
  14. Austin, Texas
  15. Austin, Texas
  16. Austin, Texas
  17. Round Rock, Texas
  18. Pessac, Be1 04495
  19. Marseille Cedex 09,
  20. Saint-Priest en Jarez Cedex,
  21. Toulouse cedex 9,
  22. Bologna,
  23. Genova,
  24. Orbassano (TO),
  25. Roma,
  26. Madrid,
  27. Valencia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-small Cell Lung CancerA Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen NCT00769067
  1. Muscle Shoals, Alabama
  2. Montebello, California
  3. Bridgeport, Connecticut
  4. Norwalk, Connecticut
  5. Waterbury, Connecticut
  6. Atlanta, Georgia
  7. Atlanta, Georgia
  8. Atlanta, Georgia
  9. Atlanta, Georgia
  10. Atlanta, Georgia
  11. Augusta, Georgia
  12. Augusta, Georgia
  13. Columbus, Georgia
  14. Decatur, Georgia
  15. Gainesville, Georgia
  16. Macon, Georgia
  17. Marietta, Georgia
  18. Warner Robins, Georgia
  19. Post Falls, Idaho
  20. Post Falls, Idaho
  21. Zion, Illinois
  22. Bethesda, Maryland
  23. Rockville, Maryland
  24. Minneapolis, Minnesota
  25. Memphis, Tennessee
  26. Clarksburg, West Virginia
  27. Camperdown, New South Wales
  28. Fitzroy, Victoria
  29. Geelong, Victoria
  30. Wodonga, Victoria
  31. Porto Alegre, RS
  32. Porto Alegre, RS
  33. Barretos, SP
  34. Sao Paulo, SP
  35. Vancouver, British Columbia
  36. Barrie, Ontario
  37. Oshawa, Ontario
  38. Ottawa, Ontario
  39. Shatin, New Territories
  40. Tuen Mun, New Territories
  41. Seoul,
  42. Seoul,
  43. Seoul,
  44. Chrzanow,
  45. Krakow,
  46. Krakow,
  47. Krakow,
  48. Warsaw,
  49. Warszawa,
  50. Ponce,
  51. Singapore,
  52. Badalona, Barcelona
  53. Palma de Mallorca, Islas Baleares
  54. Barakaldo, Vizcaya
  55. La Coruña,
  56. Taipei,
  57. Taipei,
  58. Manchester,
  59. Oxford,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Prospective Observational Study To Identify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management (IDEALK)
Official Title PROSPECTIVE OBSERVATIONAL STUDY TO IDENTIFY PATIENTS WITH ADVANCED/METASTATIC NSCLC AND ALK TRANSLOCATION AND TO ESTABLISH THEIR THERAPEUTIC MANAGEMENT (IDEALK)
Brief Summary Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management under clinical practice (IDEALK)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population NSCLS Patients, ALK + Confirmed
Condition Non-Small Cell Lung Cancer
Intervention Drug: Crizotinib
Treatment with crizotinib following routine clinical practice
Study Groups/Cohorts Routine clinical practice group (NSCLC ALK+)
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+
Intervention: Drug: Crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 10, 2016)
100
Original Estimated Enrollment
 (submitted: February 5, 2016)
1
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with Advanced or metastatic non-small cell lung cancer
  • Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
  • Age > 18 years
  • For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
  • For the treatment sub-study, patients must also meet the following criteria

    • Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
    • Patients treated with crizotinib under routine clinical practice
    • Patients with a minimum data registered at the medical history

Exclusion Criteria:

  • Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.
Sex/Gender
Sexes Eligible for Study:All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02679170
Other Study ID Numbers A8081057
IDEALK ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020