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CAR T-cell Therapy
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
Stanford, CA
Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will see if a new treatment is safe and tolerable for people with non-small cell lung cancer, with or without another existing treatment.
Eligible Conditions
- Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With AEs Leading to Dose Delays
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
+2 moreSecondary study objectives
Area Under the Plasma Concentration-time Curve to Day 28 (AUC0-28d) of Lete-cel
Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment
Duration of Response (DOR) Per RECIST Version 1.1 by Investigator Assessment
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: lete-cel plus pembrolizumabExperimental Treatment2 Interventions
In Arm C, participants with NSCLC (with actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.
Group II: Arm B: lete-cel plus pembrolizumabExperimental Treatment2 Interventions
In Arm B, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.
Group III: Arm A: lete-cel monotherapyExperimental Treatment2 Interventions
In Arm A, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel monotherapy. Participants who subsequently progress by Week 25 will be offered pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2630
Find a Location
Closest Location:GSK Investigational Site· Stanford, CA· 2105 miles
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,830 Previous Clinical Trials
8,387,981 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
Merck Sharp & Dohme LLCIndustry Sponsor
4,086 Previous Clinical Trials
5,223,883 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,611 Previous Clinical Trials
6,146,571 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors