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Spots Global Cancer Trial Database for Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

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Trial Identification

Brief Title: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

Official Title: A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination With Pembrolizumab in HLA-A2+ Participants With NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer

Study ID: NCT03709706

Conditions

Neoplasms

Study Description

Brief Summary: This trial will evaluate safety and tolerability of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with non-small cell lung cancer.

Detailed Description: New York esophageal squamous cell carcinoma-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T- cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR) engineered T-cells. This is a multi-arm, open-label study of letetresgene autoleucel (lete-cel, GSK3377794) in Human Leukocyte Antigen (HLA)-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive adults whose tumors express NY-ESO-1 and/or LAGE-1a. This study will enroll participants who have unresectable Stage IIIb or Stage IV NSCLC.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

GSK Investigational Site, Duarte, California, United States

GSK Investigational Site, La Jolla, California, United States

GSK Investigational Site, Sacramento, California, United States

GSK Investigational Site, Stanford, California, United States

GSK Investigational Site, Denver, Colorado, United States

GSK Investigational Site, Hollywood, Florida, United States

GSK Investigational Site, Atlanta, Georgia, United States

GSK Investigational Site, Chicago, Illinois, United States

GSK Investigational Site, Iowa City, Iowa, United States

GSK Investigational Site, Lexington, Kentucky, United States

GSK Investigational Site, Baltimore, Maryland, United States

GSK Investigational Site, Saint Louis, Missouri, United States

GSK Investigational Site, New York, New York, United States

GSK Investigational Site, Durham, North Carolina, United States

GSK Investigational Site, Columbus, Ohio, United States

GSK Investigational Site, Philadelphia, Pennsylvania, United States

GSK Investigational Site, Pittsburgh, Pennsylvania, United States

GSK Investigational Site, Nashville, Tennessee, United States

GSK Investigational Site, Houston, Texas, United States

GSK Investigational Site, Salt Lake City, Utah, United States

GSK Investigational Site, Toronto, Ontario, Canada

GSK Investigational Site, Montréal, Quebec, Canada

GSK Investigational Site, Amsterdam, , Netherlands

GSK Investigational Site, Groningen, , Netherlands

GSK Investigational Site, Rotterdam, , Netherlands

GSK Investigational Site, Utrecht, , Netherlands

GSK Investigational Site, Barcelona, , Spain

GSK Investigational Site, Madrid, , Spain

GSK Investigational Site, Madrid, , Spain

GSK Investigational Site, London, , United Kingdom

GSK Investigational Site, Manchester, , United Kingdom

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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