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Pilot Immunotherapy Study With Autologous T-cells Specific for NY-ESO-1/ LAGE-1a-positive Advanced NSCLC Either Alone or in Combination With Pembrolizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709706
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
Adoptive T-cell therapy (ACT) is a therapeutic approach that uses T lymphocytes of participants with cancer, obtained by leukapheresis with the aim of generating an anti-tumor T-cell immune response. New York esophageal squamous cell carcinoma 1 (NY-ESO-1) and cancer testis antigen 2 (LAGE-1a) antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using ACT with T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses in participants with cancer. Pembrolizumab is a monoclonal antibody that acts specifically on tumor targeting T-cells and increases T-cell anti-tumor function. Pembrolizumab will be used in combination with NY-ESO-1/LAGE-1a T Cell Receptors (TCR) engineered participant T-cells (GSK3377794) to potentially further improve therapy for participants. The primary objective of the study is to evaluate the safety and tolerability of autologous genetically modified T-cells (GSK3377794) in human leukocyte antigen (HLA) positive participants with NY-ES0-1/ LAGE-1a positive advanced non-small cell lung cancer (NSCLC) alone (Arm A) or GSK3377794 in combination with pembrolizumab in participants with NSCLC with wildtype epidermal growth factor receptor (WT EGFR) and WT anaplastic lymphoma kinase/ c-ros oncogene 1 (ALK/ROS1) (Arm B) and participants with NSCLC with EGFR or ALK/ROS1 aberration (Arm C). This study consists of screening phase, Leukapheresis/ GSK3377794 manufacture, lymphodepletion/treatment phase and follow-up. Participants will receive GSK3377794 as monotherapy (Arm A); or as a combination therapy with pembrolizumab (Arm B), and participants in Arm C will receive the same treatment as participants in the Arm B. Approximately 54 participants will be enrolled into the study.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: letetresgene autoleucel Drug: Pembrolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will receive either a single intravenous (IV) infusion of GSK3377794 as monotherapy or as combination therapy along with pembrolizumab IV infusion.
Masking: None (Open Label)
Masking Description: This will be an open-label study. Hence, there will be no masking.
Primary Purpose: Treatment
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
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: letetresgene autoleucel monotherapy
In Arm A, participants will receive letetresgene autoleucel monotherapy, administered as a single IV infusion of 1 to 8 x10^9 transduced cells. Participants who subsequently progress by Week 25 will be offered pembrolizumab 200 milligrams once every three weeks.
 Drug: letetresgene autoleucel
letetresgene autoleucel will be given as a single IV infusion of 1 to 8 x10^9 transduced cells.
Experimental: Arm B: letetresgene autoleucel plus pembrolizumab
In Arm B, participants will receive a single IV infusion of letetresgene autoleucel on Day 1 followed by pembrolizumab 200 milligrams on Day 22 and thereafter once every three weeks.
 Drug: letetresgene autoleucel
letetresgene autoleucel will be given as a single IV infusion of 1 to 8 x10^9 transduced cells.

Drug: Pembrolizumab
Pembrolizumab will be given as a dose of 200 milligrams using a 30-minute IV infusion.
Experimental: Arm C: letetresgene autoleucel plus pembrolizumab
In Arm C, participants will receive a single IV infusion of letetresgene autoleucel on Day 1 followed by pembrolizumab 200 milligrams on Day 22 and thereafter once every three weeks.
 Drug: letetresgene autoleucel
letetresgene autoleucel will be given as a single IV infusion of 1 to 8 x10^9 transduced cells.

Drug: Pembrolizumab
Pembrolizumab will be given as a dose of 200 milligrams using a 30-minute IV infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs) in participants who received GSK3377794 alone or in combination with pembrolizumab [ Time Frame: Up to 106 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment.

  2. Number of participants with adverse events of different severity in participants who received GSK3377794 alone or in combination with pembrolizumab [ Time Frame: Up to 106 weeks ]
    The severity of AEs will be graded according to National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) version 4.03.

  3. Number of participants with AEs and SAEs leading to dose delays [ Time Frame: Up to 106 weeks ]
    Number of participants with AEs and SAEs leading to dose delays will be reported.

  4. Number of participants with AEs and SAEs leading to withdrawals [ Time Frame: Up to 106 weeks ]
    Number of participants with AEs and SAEs leading to withdrawals will be reported.

  5. Number of participants with abnormal findings for hematology parameters [ Time Frame: Up to 106 weeks ]
    Blood samples will be collected for analysis of hematology parameters including platelet counts, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, red blood cell count (RBC), hemoglobin and hematocrit.

  6. Number of participants with abnormal findings for clinical chemistry parameters [ Time Frame: Up to 106 weeks ]
    Blood samples will be collected for analysis of clinical chemistry parameters including blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total and direct bilirubin, creatinine, sodium, alanine aminotransferase (ALT), total protein, glucose, calcium, alkaline phosphatase, chloride, albumin, phosphorus, low density lipid (LDH), urea, potassium, magnesium and bicarbonate.

  7. Number of participants with abnormal findings for urinalysis parameters [ Time Frame: Up to 106 weeks ]
    Urine samples will be collected for the analysis of the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite and leukocyte esterase by dipstick.

  8. Number of of participants with abnormal findings for vital signs [ Time Frame: Up to 106 weeks ]
    Vital sign parameters including systolic and diastolic blood pressure, respiratory rate, pulse rate, and temperature will be assessed.

  9. Mean Eastern Cooperative Oncology Group (ECOG) performance status score [ Time Frame: Up to 106 weeks ]
    ECOG performance status is a measure of the participant's ability to carry out activities of daily living on a 6-point scale ranging from 0 (fully active) to 5 (Dead).

  10. Number of participants with abnormal electrocardiogram (ECG) findings [ Time Frame: Up to 106 weeks ]
    Twelve-lead ECG will be obtained using an ECG machine.

  11. Overall response rate (ORR) [ Time Frame: Up to 106 weeks ]
    ORR is the percentage of participants with a confirmed complete response (CR) or a partial response (PR) at any time as per Response evaluation criteria in solid tumors (RECIST) version 1.1 as determined by the local investigators.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to 106 weeks ]
    PFS is defined as the time from the date of T-cell infusion until the earliest date of disease progression as per RECIST version 1.1 as determined by the local investigators, or death due to any cause.

  2. Disease Control Rate (DCR) [ Time Frame: Up to 106 weeks ]
    DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) for at least 6 months as per RECIST version 1.1 as determined by the local investigators.

  3. Duration of Response (DoR) [ Time Frame: Up to 106 weeks ]
    DoR is defined as, in the subset of participants who show a confirmed CR or PR as determined by the local investigators, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.

  4. Time to Response (TTR) [ Time Frame: Up to 106 weeks ]
    TTR is the time from the date of T-cell infusion to the first documented evidence of response (PR or better) in the subset of participants who achieved a confirmed PR or CR as determined by the local investigators.

  5. Maximum observed concentration (Cmax) following administration of monotherapy of GSK3377794 [ Time Frame: Up to 106 weeks post-dose ]
    Blood samples will be collected for pharmacokinetic analysis.

  6. Cmax following administration of combination therapy of GSK3377794 [ Time Frame: Up to 106 weeks post-dose ]
    Blood samples will be collected for pharmacokinetic analysis.

  7. Time to Cmax (Tmax) following administration of monotherapy of GSK3377794 [ Time Frame: Up to 106 weeks post-dose ]
    Blood samples will be collected for pharmacokinetic analysis

  8. Tmax following administration of combination therapy of GSK3377794 [ Time Frame: Up to 106 weeks post-dose ]
    Blood samples will be collected for pharmacokinetic analysis.

  9. Area under the time curve from zero to time t (AUC[0 to t]) following administration of monotherapy of GSK3377794 [ Time Frame: Up to 106 weeks post-dose ]
    Blood samples will be collected for pharmacokinetic analysis.

  10. AUC(0 to t) following administration of combination therapy of GSK3377794 [ Time Frame: Up to 106 weeks post-dose ]
    Blood samples will be collected for pharmacokinetic analysis.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Screening (Part 1):

  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Participant must be positive for Human leukocyte antigen (HLA)-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a validated test in a designated central laboratory.
  • Participant's tumor has been pathologically reviewed by a designated central laboratory with confirmed positive expression of NY-ESO-1 and/or, if tested, LAGE-1a.
  • Age >=18 years on the day of signing informed consent for the screening process.
  • Pending approval of Medical Monitor (or designee), participants can be enrolled in other experimental interventional clinical studies during the screening and leukapheresis stages of this study (GSK208471).
  • Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV NSCLC.
  • ECOG Performance Status of 0 or 1.
  • Predicted life expectancy that is >=3 months.
  • Participant has left ventricular ejection fraction >=50 percent (%) or as per institution's guidelines.
  • Adequate venous access for leukapheresis.
  • In the Investigator's opinion, the participant is fit for lymphodepleting chemotherapy and infusion of GSK3377794.

Leukapheresis (Part 2):

  • In the Investigator's opinion, the participant is suitable for leukapheresis including laboratory parameters as described in the protocol.
  • Leukapheresis can be collected between the lines of therapies
  • An intermediate standard of care (SoC) line of therapy between leukapheresis (Part 2) and treatment (Part 3) at the time of disease progression is allowed.

Lymphodepletion/Treatment (Part 3):

  • All participants with NSCLC with WT EGFR and WT ALK/ ROS1 (Arms A and B) should have received and failed at least one line of programmed death protein 1/programmed death protein 1 ligand (PD-1/PD-L1) checkpoint blockade therapy (alone or in combination with systemic chemotherapy).
  • All participants with NSCLC with EGFR or ALK/ROS1 aberration (Arm C only) should have received and failed appropriate targeted therapy following National Comprehensive Cancer Network (NCCN) guidelines. These participants could have received and failed PD-1/PD-L1 checkpoint blockade therapy.
  • Experimental systemic regimens are allowed.
  • Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV NSCLC with measurable disease per RECIST version 1.1 as assessed by local site investigator/radiology.
  • Central nervous system (CNS) metastases with low CNS disease burden are allowed on a case by case basis after benefit-risk evaluation in consultation with the Sponsor Medical Monitor (or designee).
  • A biopsy of tumor tissue obtained following cessation of the last line of treatment for NSCLC but within 2 weeks prior to initiating lymphodepleting chemotherapy is required unless clinically unsafe to do so.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • A female participants are eligible to participate if they are not pregnant or breastfeeding and if she is not of childbearing potential.
  • Participant must have adequate organ function as described in the protocol.

Pembrolizumab therapy following disease progression after GSK3377794 infusion (Arm A only, Part 4):

  • Participants who have received GSK3377794 in Arm A are eligible for therapy with pembrolizumab 200 milligrams flat dose once every 3 weeks if they fulfil certain criteria.

Exclusion Criteria:

For Screening (Part 1):

  • NSCLC with B-Raf gene (BRAF) V600E mutation, Neurotrophic Tropomyosin-Related Kinase (NTRK) gene fusion, and/or any other actionable genetic aberration that can be treated with targeted SoC (NCCN recommended) therapy.
  • Prior therapies: Arm A and B: Has received and failed >=3 lines of systemic therapy. Arm C: Has received >=4 lines of systemic therapy.
  • Any prior treatment with oncology cell therapy (TCR-T-cell therapy or chimeric antigen receptor [CAR]-T therapy); Prior gene therapy using an integrating vector.
  • Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression.
  • Prior malignancy other than NSCLC, with exceptions: agreed upon consultation between the Investigator and Sponsor Medical Monitor (or designee).
  • Participant has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Participant has a history of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
  • Prior allogeneic/autologous bone marrow or solid organ transplantation with some exceptions if occurred more than 5 years ago.
  • Uncontrolled intercurrent illness.
  • Prior or active demyelinating disease.
  • Current unstable liver or biliary disease per Investigator assessment.
  • Participant has positive viral serology as defined in protocol.
  • Participant is pregnant or breastfeeding.
  • Has known psychiatric or substance abuse disorders.

Leukapheresis (Part 2):

  • Toxicity from previous anti-cancer therapy that has not recovered to CTCAE version 4.03 Grade <=1 prior to enrollment (except for non-clinically significant toxicities, e.g.,alopecia, vitiligo). Participants with existing pneumonitis because of radiation are not excluded; however, participants cannot be oxygen-dependent. Participants with Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled on a case-by-case basis with prior consultation and agreement with the Sponsor Medical Monitor (or designee).
  • Investigational treatment within 30 days or 5 half-lives (whichever is shorter) prior to leukapheresis.
  • Radiotherapy that involves >25% bone marrow exposure.

Lymphodepletion/ Treatment (Part 3):

  • Has received a live vaccine within 30 days prior to the first dose of study drug.
  • Major surgery <=28 days before first dose of study treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709706


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
Duarte, California, United States, 91010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Erminia Massarelli         
GSK Investigational Site Recruiting
La Jolla, California, United States, 92093-0987
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sandip P Patel         
GSK Investigational Site Recruiting
Sacramento, California, United States, 95817
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jonathan Riess         
GSK Investigational Site Recruiting
Stanford, California, United States, 94305
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Joel W Neal         
United States, Colorado
GSK Investigational Site Recruiting
Denver, Colorado, United States, 80218
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gerald Falchook         
United States, Florida
GSK Investigational Site Recruiting
Hollywood, Florida, United States, 33021
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gilberto Lopes         
United States, Georgia
GSK Investigational Site Recruiting
Atlanta, Georgia, United States, 30322
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Taofeek Kunle Owonikoko         
United States, Illinois
GSK Investigational Site Recruiting
Chicago, Illinois, United States, 60637
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Everett Vokes         
United States, Kentucky
GSK Investigational Site Recruiting
Lexington, Kentucky, United States, 40536
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: John Villano         
United States, Maryland
GSK Investigational Site Recruiting
Baltimore, Maryland, United States, 21201
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Christian Rolfo         
United States, Missouri
GSK Investigational Site Recruiting
Saint Louis, Missouri, United States, 63110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ramaswamy Govindan         
United States, New York
GSK Investigational Site Recruiting
New York, New York, United States, 10065
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marjorie G Zauderer         
United States, North Carolina
GSK Investigational Site Recruiting
Durham, North Carolina, United States, 27710
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jeffrey Clarke         
United States, Ohio
GSK Investigational Site Recruiting
Columbus, Ohio, United States, 43210
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Kai He         
United States, Pennsylvania
GSK Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Martin J. Edelman         
GSK Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Liza Villaruz         
United States, Tennessee
GSK Investigational Site Recruiting
Nashville, Tennessee, United States, 37203
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Melissa L Johnson         
United States, Texas
GSK Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mehmet Altan         
United States, Utah
GSK Investigational Site Recruiting
Salt Lake City, Utah, United States, 84112-5550
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Wallace L Akerley         
Canada, Ontario
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Adrian Sacher         
Canada, Quebec
GSK Investigational Site Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Simon Turcotte         
Netherlands
GSK Investigational Site Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: John B.A.G. Haanen         
GSK Investigational Site Recruiting
Groningen, Netherlands, 9713 GZ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Thijo J.N. Hiltermann         
GSK Investigational Site Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Martijn P.J.K. Lolkema         
GSK Investigational Site Recruiting
Utrecht, Netherlands, 3584 CX
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Eelke H. Gort         
Spain
GSK Investigational Site Recruiting
Barcelona, Spain, 08035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Enriqueta Felip         
GSK Investigational Site Recruiting
Madrid, Spain, 28040
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Victor Moreno García         
GSK Investigational Site Recruiting
Madrid, Spain, 28050
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Emiliano Calvo Aller         
United Kingdom
GSK Investigational Site Recruiting
London, United Kingdom, WC1E 6AG
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Martin Forster         
GSK Investigational Site Recruiting
Manchester, United Kingdom, M20 4BX
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Fiona Thistlethwaite         
Sponsors and Collaborators
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03709706    
Other Study ID Numbers: 208471
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
GSK3377794
Pembrolizumab
T Cell Receptors
Adoptive T-cell therapy
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents