A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

NCT02364999

Last updated date
Study Location
Southern Cancer Center, PC
Daphne, Alabama, 36526, United States
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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female patients age at least 18 years of age, or age of consent in the region.

- Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC) for which they had not received chemotherapy for metastatic disease.

- Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.

- Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.

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


- Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and
mixed adenosquamous carcinomas of predominantly squamous nature.


- Evidence of a tumor that compresses or invades major blood vessels or tumor
cavitation that in the opinion of the investigator is likely to bleed.


- Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK
translocation positive mutations.

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 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  ICMJE A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
Official Title  ICMJE A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.
Brief Summary This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Bevacizumab-Pfizer
    Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.
  • Drug: Bevacizumab-EU
    bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.
  • Drug: Paclitaxel
    Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
  • Drug: Carboplatin
    carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
Study Arms  ICMJE
  • Experimental: Bevacizumab-Pfizer
    Bevacizumab-Pfizer plus paclitaxel and carboplatin
    Interventions:
    • Drug: Bevacizumab-Pfizer
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Active Comparator: Bevacizumab-EU
    Bevacizumab-EU plus paclitaxel and carboplatin
    Interventions:
    • Drug: Bevacizumab-EU
    • Drug: Paclitaxel
    • Drug: Carboplatin
Publications *

*   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: July 17, 2017)
719
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2015)
798
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients age at least 18 years of age, or age of consent in the region.
  • Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
  • Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
  • Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.

Exclusion Criteria:

  • Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
  • Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
  • Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
  • Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
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 Australia,   Brazil,   Bulgaria,   Chile,   Croatia,   Czechia,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries Czech Republic,   Hong Kong,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT02364999
Other Study ID Numbers  ICMJE B7391003
2014-003878-16 ( EudraCT Number )
B7391003 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 2019

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