A Phase 2 interventional study of Screening Platform in Neoplasms, sponsored by GlaxoSmithKline. Terminated at 3 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Other
This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study.
Other: Screening Platform
Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.
Number of Participants With Human Leukocyte Antigen (HLA) A Genotypes Status
Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous.
Time frame: Up to 2 weeks
This screening study was intended to determine potential eligibility of participants for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. The study was terminated early due to feasibility reasons.
| Milestone | Participants With Non-small Cell Lung Cancer (NSCLC) |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Blood samples were collected for HLA compatibility testing. Number of participants with eligible human leukocyte antigen (HLA) A genotypes status are presented. Data has been reported for following categories: One HLA Allele Positive, Two HLA Allele Positive, Negative and Ambiguous.
| Participants | Participants With Non-small Cell Lung Cancer (NSCLC) |
|---|---|
| One HLA Allele Positive | 9 |
| Two HLA Allele Positive | 1 |
| Negative | 6 |
| Ambiguous | 0 |
Collected over All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Non-small Cell Lung Cancer (NSCLC) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(Years) | Participants With Non-small Cell Lung Cancer (NSCLC) |
|---|---|
| Mean | 63.8 ± 7.49 |
| Sex: Female, Male(Participants) | Participants With Non-small Cell Lung Cancer (NSCLC) |
|---|---|
| Female | 9 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | Participants With Non-small Cell Lung Cancer (NSCLC) |
|---|---|
| ASIAN - JAPANESE HERITAGE | 1 |
| BLACK OR AFRICAN AMERICAN | 2 |
| WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE | 13 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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