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)

Back to Search
Print
Bookmark Trial

NCT02679170

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
H.U. La Paz
Madrid, , 28046, Spain
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 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]

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 CancerStudy of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)
NCT02920450
  1. Gainesville, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CancerEffect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy
NCT00300729
  1. Gothenburg,
  2. Jönköping,
  3. Kalmar,
  4. Linköping,
  5. Lund,
  6. Malmö,
  7. Skövde,
  8. Trollhättan,
  9. Uddevalla,
  10. Umeå,
  11. Uppsala,
  12. Ystad,
  13. Örebro,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CancerA Phase I Study of SUNITINIB and Rapamycin in Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT00555256
  1. St. Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-small Cell Lung CancerAn Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer
NCT03915951
  1. Altamonte Springs, Florida
  2. Bonita Springs, Florida
  3. Bradenton, Florida
  4. Brandon, Florida
  5. Cape Coral, Florida
  6. Clearwater, Florida
  7. Fleming Island, Florida
  8. Fort Myers, Florida
  9. Fort Myers, Florida
  10. Gainesville, Florida
  11. Largo, Florida
  12. Lecanto, Florida
  13. Naples, Florida
  14. New Port Richey, Florida
  15. Ocala, Florida
  16. Orange City, Florida
  17. Orlando, Florida
  18. Port Charlotte, Florida
  19. Saint Petersburg, Florida
  20. Sarasota, Florida
  21. Sarasota, Florida
  22. Spring Hill, Florida
  23. Tallahassee, Florida
  24. Tampa, Florida
  25. Tavares, Florida
  26. The Villages, Florida
  27. Venice, Florida
  28. Winter Park, Florida
  29. Atlanta, Georgia
  30. Atlanta, Georgia
  31. Atlanta, Georgia
  32. Johns Creek, Georgia
  33. Overland Park, Kansas
  34. Baltimore, Maryland
  35. Baltimore, Maryland
  36. Creve Coeur, Missouri
  37. Independence, Missouri
  38. Kansas City, Missouri
  39. Saint Louis, Missouri
  40. Saint Louis, Missouri
  41. Saint Louis, Missouri
  42. New York, New York
  43. New York, New York
  44. Durham, North Carolina
  45. Columbus, Ohio
  46. Columbus, Ohio
  47. Columbus, Ohio
  48. Columbus, Ohio
  49. Columbus, Ohio
  50. Columbus, Ohio
  51. Columbus, Ohio
  52. Gahanna, Ohio
  53. Lewis Center, Ohio
  54. Clackamas, Oregon
  55. Newberg, Oregon
  56. Chattanooga, Tennessee
  57. Cleveland, Tennessee
  58. Dickson, Tennessee
  59. Franklin, Tennessee
  60. Gallatin, Tennessee
  61. Hendersonville, Tennessee
  62. Hermitage, Tennessee
  63. Lebanon, Tennessee
  64. Murfreesboro, Tennessee
  65. Nashville, Tennessee
  66. Nashville, Tennessee
  67. Nashville, Tennessee
  68. Nashville, Tennessee
  69. Shelbyville, Tennessee
  70. Smyrna, Tennessee
  71. Kingwood, Texas
  72. The Woodlands, Texas
  73. Roma, Lazio
  74. Orbassano, Torino
  75. Orbassano, Torino
  76. Orbassano, Torino
  77. Orbassano, Torino
  78. Orbassano, Torino
  79. Orbassano, Torino
  80. Napoli,
  81. Torino,
  82. Barcelona,
  83. Cordoba,
  84. Cordoba,
  85. Esplugues de Llobregat,
  86. L'Hospitalet,
  87. Malaga,
  88. Sevilla,
  89. Los Angeles, California
  90. Santa Monica, California
  91. Norwich, Connecticut
  92. Norwich, Connecticut
  93. Norwich, Connecticut
  94. Putnam, Connecticut
  95. Fort Myers, Florida
  96. Saint Petersburg, Florida
  97. Tallahassee, Florida
  98. Venice, Florida
  99. Atlanta, Georgia
  100. Chicago, Illinois
  101. Overland Park, Kansas
  102. Baltimore, Maryland
  103. Baltimore, Maryland
  104. Boston, Massachusetts
  105. Boston, Massachusetts
  106. Boston, Massachusetts
  107. Boston, Massachusetts
  108. Boston, Massachusetts
  109. Boston, Massachusetts
  110. Chelsea, Massachusetts
  111. Danvers, Massachusetts
  112. Marlborough, Massachusetts
  113. Stoneham, Massachusetts
  114. Stoneham, Massachusetts
  115. Waltham, Massachusetts
  116. Independence, Missouri
  117. Kansas City, Missouri
  118. Saint Louis, Missouri
  119. Basking Ridge, New Jersey
  120. Hackensack, New Jersey
  121. Montvale, New Jersey
  122. Bronx, New York
  123. Bronx, New York
  124. Bronx, New York
  125. New York, New York
  126. New York, New York
  127. New York, New York
  128. New York, New York
  129. Portland, Oregon
  130. Portland, Oregon
  131. Pittsburgh, Pennsylvania
  132. Pittsburgh, Pennsylvania
  133. Pittsburgh, Pennsylvania
  134. Pittsburgh, Pennsylvania
  135. York, Pennsylvania
  136. York, Pennsylvania
  137. Chattanooga, Tennessee
  138. Chattanooga, Tennessee
  139. Houston, Texas
  140. Houston, Texas
  141. Shenandoah, Texas
  142. Seattle, Washington
  143. Faenza, Emilia-romagna
  144. Lugo, Emilia-romagna
  145. Ravenna, Emilia-romagna
  146. Ravenna, Emilia-romagna
  147. Rimini, Emilia-romagna
  148. Milano, Lombardia
  149. Milano, Lombardia
  150. Napoli, Naples
  151. Cattolica, Rimini
  152. Orbassano, Torino
  153. Bologna,
  154. Milano,
  155. Naples,
  156. Goyang-si, Gyeonggido
  157. Jeonnam,
  158. Seoul,
  159. Seoul,
  160. Seoul,
  161. Amsterdam, Noord-holland
  162. Amsterdam, Noord-holland
  163. Groningen,
  164. Hospitalet de Llobregat, Barcelona
  165. L'Hospitalet de Llobregat, Barcelona
  166. L'Hospitalet de Llobregat, Barcelona
  167. Majadahonda, Madrid
  168. Malaga, Málaga
  169. Barcelona,
  170. Barcelona,
  171. Barcelona,
  172. Barcelona,
  173. Hospitalet de Llobregat,
  174. Madrid,
  175. Madrid,
  176. Sevilla,
  177. Sevilla,
  178. Sevilla,
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 December 31, 2021
Estimated Primary Completion Date December 31, 2021   (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 September 2020