Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer


Last updated date
Study Location
Moffitt Cancer Center
Tampa, Florida, 33612, 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

Umbrella Phase 1b & 2:

- Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.

- At least one measurable lesion per RECIST v1.1 at Screening.

- ECOG Performance Status 0 or 1.

- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

- Adequate hepatic, renal, and bone marrow function.


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

for Sub-Study A Phase 2 only:

-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.


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

Pfizer Clinical Trials Contact Center


[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.


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 CarcinomaUmbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer
  1. Tampa, Florida
  2. Concord, New South Wales
  3. Duarte, California
  4. Duarte, California
  5. Encinitas, California
  6. Fresno, California
  7. Glendale, California
  8. La Jolla, California
  9. La Jolla, California
  10. La Jolla, California
  11. La Jolla, California
  12. La Jolla, California
  13. La Jolla, California
  14. Long Beach, California
  15. Los Angeles, California
  16. San Diego, California
  17. Santa Ana, California
  18. Vista, California
  19. Whittier, California
  20. Colorado Springs, Colorado
  21. Colorado Springs, Colorado
  22. Celebration, Florida
  23. Celebration, Florida
  24. Orlando, Florida
  25. Orlando, Florida
  26. Orlando, Florida
  27. Baltimore, Maryland
  28. Baltimore, Maryland
  29. Dearborn, Michigan
  30. Detroit, Michigan
  31. Novi, Michigan
  32. Las Vegas, Nevada
  33. Morristown, New Jersey
  34. Morristown, New Jersey
  35. Summit, New Jersey
  36. Summit, New Jersey
  37. New York, New York
  38. New York, New York
  39. Camperdown, New South Wales
18 Years+
Non-Small-Cell Lung CarcinomaMEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer
  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
18 Years+
Non-Small-Cell Lung CarcinomaStudy Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
  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,
18 Years+
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
  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,
18 Years+
Advanced Information
Descriptive Information
Brief Title  ICMJE Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer
Official Title  ICMJE A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)
Brief Summary

Phase 1b/Phase 2 open-label, multi-center, parallel group umbrella study.

Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Sasanlimab Prefillled syringe
    prefilled syringe
  • Drug: Encorafenib
  • Drug: Binimetinib
Study Arms  ICMJE Experimental: Sub-Study A
Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.
  • Drug: Sasanlimab Prefillled syringe
  • Drug: Encorafenib
  • Drug: Binimetinib
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 27, 2024
Estimated Primary Completion Date November 27, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria Umbrella Phase 1b & 2:

  • Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC.
  • At least one measurable lesion per RECIST v1.1 at Screening.
  • ECOG Performance Status 0 or 1.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ?1.
  • Adequate hepatic, renal, and bone marrow function.

Additional Inclusion Criteria for Sub-Study A Phase 1b &2:

-BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report.

Additional Inclusion Criteria for Sub-Study A Phase 1b only:

-Any line of therapy for locally advanced/metastatic NSCLC.

Additional Inclusion Criteria for Sub-Study A Phase 2 only:

-Previously untreated for locally advanced/metastatic NSCLC

Exclusion Criteria Umbrella Phase 1b &2:

  • Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis.
  • Active infection requiring systemic therapy.
  • Clinically significant cardiovascular disease.
  • Other malignancy within 2 years of first dose, with exceptions.
  • Symptomatic brain metastasis, with exceptions.

Additional Exclusion Criteria for Sub-Study A Phase 1b &2:

  • EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement.
  • Prior treatment with any BRAF inhibitor or MEK inhibitor.

Additional Exclusion Criteria for Sub-Study A Phase 2 only:

-Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.

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: Pfizer Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04585815
Other Study ID Numbers  ICMJE B8011011
2020-002829-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

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