The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy as treatment for non–small cell lung cancer (NSCLC). These studies are researching programmed cell death ligand 1 (PD-L1) antibody therapy; hypofractionated radiotherapy; chemoradiotherapy; positron-emission tomography/computed tomography (PET/CT) as a biomarker of immunotherapeutic response; T-cell therapy; tumor-infiltrating lymphocytes; overcoming genetic resistance to therapy; combination chemotherapy and immunotherapy; and more.
All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Pilot
Study Title: A Pilot Study of MPDL3280A (PD-L1) Antibody Therapy and Hypofractionated Image-Guided Radiotherapy (HIGRT) in Patients With Metastatic NSCLC
Study Type: Phase 0/interventional/single-group assignment
Study Sponsor and Collaborators: University of Michigan Cancer Center, University of Washington
Purpose: To study whether a brief course of radiation therapy given to one area affected by the cancer will improve the chances of responding to immunotherapy in the form of MPDL3280A, an antibody against PD-L1
Primary Outcome Measures: The number of participants who respond to a combination of HIGRT and MPDL3280A (PD-L1) [time frame: 5 years]
Principal Investigator: Nithya Ramnath, MD, University of Michigan Cancer Center; (734) 647-1417, nithyar@umich.edu
ClinicalTrials.gov Identifier: NCT02463994
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Study Title: Serial [18F] Fluorodeoxyglucose ([18F]FDG)PET/CT as a Biomarker of Therapeutic Response in Anti–PD-1 (programmed cell death protein 1)/PD-L1 Therapy
Study Type: Phase 0/interventional/single-group assignment
Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania
Purpose: To compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with clinical markers of response. PET/CT tumor metabolic response will also be correlated to progression-free survival and overall survival.
Primary Outcome Measures: Number of inflammatory changes within the tumor [time frame: 2 years]
Principal Investigator: Sharyn Katz, MD, Abramson Cancer Center of the University of Pennsylvania; (855) 216-0098, penncancertrials@emergingmed.com
ClinicalTrials.gov Identifier: NCT02608528
Phase I/II
Study Title: Phase I/II Study in WT1-Expressing NSCLC and Mesothelioma, Comparing Cellular Adoptive Immunotherapy With Polyclonal Autologous Central Memory to Naive CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T-Cell Receptor
Study Type: Phase I/II/interventional/parallel assignment
Study Sponsor and Collaborators: Fred Hutchinson Cancer Research Center National Cancer Institute
Purpose: To study the side effects and best dose of genetically modified T cells in treating patients with stage III–IV NSCLC or mesothelioma
Primary Outcome Measures: Evidence and nature of toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [time frame: up to 6 months after the first T-cell infusion]; feasibility of naive T cell (TN) and central memory T cell (TCM) subsets, measured as the proportion of patients for which T cells are successfully generated and infused and whether only TN or TCM could be generated [time frame: up to 4 weeks]; Persistence of transduced T cells [time frame: up to 15 years]
Principal Investigator: Sylvia Lee, MD, Fred Hutch/University of Washington Cancer Consortium; (206) 288-2274, smlee@fredhutch.org
ClinicalTrials.gov Identifier: NCT02408016
Phase II
Study Title: A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With NSCLC Following Nonmyeloablative Lymphocyte-Depleting Preparative Regimen
Study Type: Phase II/interventional/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute, National Institutes of Health Clinical Center
Purpose: To study whether specifically selected T-cell receptor immunotherapy can cause NSCLC tumors to shrink and to see whether this treatment is safe
Primary Outcome Measures: Determine the rate of tumor regression [time frame: approximately 5 years]
Principal Investigator: James C. Yang, MD, National Cancer Institute; (301) 496-1574, jamesyang@mail.nih.gov
ClinicalTrials.gov Identifier: NCT02133196
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Study Title: Phase II Pilot Study Evaluating Strategies to Overcome Resistance at the Time of Progression for Patients With NSCLCs Harboring Major Oncogenic Drivers
Study Type: Phase II/Interventional/Parallel Assignment
Study Sponsor and Collaborators: Comprehensive Cancer Center of Wake Forest University, National Cancer Institute
Purpose: To study how well targeted therapy works in treating patients with incurable NSCLC with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.
Primary Outcome Measures: Objective response rate in patients with high PD-L1–expressing cancers after failure of targeted therapy defined as complete or partial response, according to the investigator’s assessment [time frame: up to 3 years]
Principal Investigator: William Petty, MD, Comprehensive Cancer Center of Wake Forest University; (336) 716-3313, wpetty@wakehealth.edu
ClinicalTrials.gov Identifier: NCT02949843
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Study Title: Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxelal Consolidation With Nab-paclitaxel Followed by Pembrolizumab and Concurrent Consolidation With Nab-paclitaxel and Pembrolizumab After Standard First-Line Induction Chemotherapy in Advanced NSCLC
Study Type: Phase II/interventional/factorial assignment
Study Sponsor and Collaborators: UNC Lineberger Comprehensive Cancer Center
Purpose: To test the effectiveness of three treatment arms that are designed to improve survival in patients with NSCLC. Eligible subjects could be randomized to four cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.
Primary Outcome Measures: Overall survival [time frame: 15 months]
Principal Investigator: Jared Weiss, MD, University of North Carolina, Chapel Hill; contact Sarah Newton, (919) 966-4432, sarah_newton@med.unc.edu
ClinicalTrials.gov Identifier: NCT02684461 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
