Clinical trial · Observational
Personalizing Immune Checkpoint Inhibitor Therapy
Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors
NCT03409341CI-TRIAL-00047306withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No enrollment
Summary
Brief summary (as posted)
This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and tumor tissue analysis, Clinical response. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Anti-tumor immune response
- timeFrame
- 12 months
- description
- Tumor antigen presentation and anti-tumor T-cell response
Secondary outcomes (2)
- measure
- Clinical response
- timeFrame
- 12 months for each subject
- description
- Clinical response is defined as 50% or greater decrease of the sum of the products of two-dimensional measurements of lesions on imaging within the first year.
- measure
- Tumor microenvironment
- timeFrame
- 24 months total study duration
- description
- Tumor mutation burden from tumor genome landscape using DNA sequencing, tumor transcriptome with RNA sequencing, tumor infiltrating immune cells with flow cytometry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors * Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy * Informed consent Exclusion Criteria: • Lack of informed consent
References
Publications (6)
- BACKGROUNDSindhi R, Ashokkumar C, Higgs BW. Cellular alloresponses for rejection-risk assessment after pediatric transplantation. Curr Opin Organ Transplant. 2011 Oct;16(5):515-21. doi: 10.1097/MOT.0b013e32834a94e3. PMID 21844808
- BACKGROUNDAshokkumar C, Talukdar A, Sun Q, Higgs BW, Janosky J, Wilson P, Mazariegos G, Jaffe R, Demetris A, Dobberstein J, Soltys K, Bond G, Thomson AW, Zeevi A, Sindhi R. Allospecific CD154+ T cells associate with rejection risk after pediatric liver transplantation. Am J Transplant. 2009 Jan;9(1):179-91. doi: 10.1111/j.1600-6143.2008.02459.x. Epub 2008 Oct 31. PMID 18976293
- BACKGROUNDNingappa M, Ashokkumar C, Higgs BW, Sun Q, Jaffe R, Mazariegos G, Li D, Weeks DE, Subramaniam S, Ferrell R, Hakonarson H, Sindhi R. Enhanced B Cell Alloantigen Presentation and Its Epigenetic Dysregulation in Liver Transplant Rejection. Am J Transplant. 2016 Feb;16(2):497-508. doi: 10.1111/ajt.13509. Epub 2015 Dec 11. PMID 26663361
- BACKGROUNDRanganathan S, Ningappa M, Ashokkumar C, Higgs BW, Min J, Sun Q, Schmitt L, Subramaniam S, Hakonarson H, Sindhi R. Loss of EGFR-ASAP1 signaling in metastatic and unresectable hepatoblastoma. Sci Rep. 2016 Dec 2;6:38347. doi: 10.1038/srep38347. PMID 27910913
- BACKGROUNDVinayak R, Cruz RJ Jr, Ranganathan S, Mohanka R, Mazariegos G, Soltys K, Bond G, Tadros S, Humar A, Marsh JW, Selby RR, Reyes J, Sun Q, Haberman K, Sindhi R. Pediatric liver transplantation for hepatocellular cancer and rare liver malignancies: US multicenter and single-center experience (1981-2015). Liver Transpl. 2017 Dec;23(12):1577-1588. doi: 10.1002/lt.24847. PMID 28834194
- BACKGROUNDCruz RJ Jr, Ranganathan S, Mazariegos G, Soltys K, Nayyar N, Sun Q, Bond G, Shaw PH, Haberman K, Krishnamurti L, Marsh JW, Humar A, Sindhi R. Analysis of national and single-center incidence and survival after liver transplantation for hepatoblastoma: new trends and future opportunities. Surgery. 2013 Feb;153(2):150-9. doi: 10.1016/j.surg.2012.11.006.