The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapies in lung cancer. These trials are studying combination therapies, radiotherapy plus immunotherapy, cancer vaccines, identifying biomarkers to immunotherapy response, 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 Interlesional IL-2 and Hypofractionated Radiotherapy in Patients With Metastatic Non–Small Cell Lung Cancer (NSCLC) Who Are Refractory to PD-1/PD-L1 Blockade

Study Type: Interventional/nonrandomized/parallel assignment

Study Sponsor and Collaborators: University of California, Davis

Purpose: To test the feasibility of a combinatorial immunotherapy strategy consisting of radiotherapy, intralesional IL-2, and checkpoint blockade (programmed cell death protein 1 [PD-1]/-programmed cell death ligand 1 [PD-L1] blockade) for patients with metastatic NSCLC whose disease has progressed after checkpoint inhibition

Primary Outcome Measures: Dose-limiting toxicity [time frame: beginning of treatment to up to 12 months after beginning of treatment]

Principal Investigator: Arta Monjazeb, MD, University of California, Davis; contact Kristy Lundahl, MS, (720) 270-9458; krlundahl@ucdavis.edu

ClinicalTrials.gov Identifier: NCT03224871

PHASE I

Study Title: A Randomized Phase I Trial to Evaluate Concurrent or Sequential Ipilimumab, Nivolumab, and Stereotactic Body Radiotherapy in Patients With Stage IV NSCLC (COSINR Study)

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: University of Chicago

Purpose: To determine whether patients with stage IV NSCLC randomly assigned to nivolumab/ipilimumab plus either sequential or concurrent stereotactic body radiotherapy respond more to a certain kind of radiation therapy

Primary Outcome Measures: Number of serious adverse events [time frame: up to 4 years]

Principal Investigator: Jyoti Patel, MD, University of Chicago; (773) 702-6149, jpatel25@medicine.bsd.uchicago.edu

ClinicalTrials.gov Identifier: NCT03223155

PHASE I/II

Study Title: Vaccination of Advanced-Stage Lung Cancer Patients: A Phase I/II Study of a Carbohydrate Mimotope–Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: University of Arkansas

Purpose: To evaluate the clinical efficacy of an investigational agent—P10s-PADRE, a peptide mimotope-based vaccine—in combination with standard-of-care treatment in subjects with advanced-stage lung cancer

Primary Outcome Measures: Number of participants with vaccine-related adverse events as assessed by the Common Terminology Criteria for Adverse Events, version 4.0 [time frame: 64 weeks 2 weeks per subject]

Principal Investigator: Konstantinos Arnaoutakis, MD, University of Arkansas; karnaoutakis@uams.edu

ClinicalTrials.gov Identifier: NCT02264236

PHASE II

Study Title: Phase II Evaluation of Nivolumab, an Immune Checkpoint Inhibitor, Alone or in Combination With Oral Decitabine/Tetrahydrouridine as Second-Line Therapy for NSCLC

Study Type: Interventional/randomized/parallel assignment

Study Sponsor and Collaborators: Case Comprehensive Cancer Center

Purpose: To assess whether treatment with the study drug tetrahydrouridine-decitabine in combination with nivolumab is more effective than treatment with nivolumab alone in patients with NSCLC

Primary Outcome Measures: Objective response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [time frame: up to 52 weeks after beginning therapy]

Principal Investigator: Vamsidhar Velcheti, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; (216) 444-8665, velchev@ccf.org

ClinicalTrials.gov Identifier: NCT02664181

MISCELLANEOUS

Study Title: Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in NSCLC

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: West Virginia University, West Virginia Clinical & Translational Science Institute 

Purpose: To determine whether the addition of radiation therapy may improve the response of NSCLC to immunotherapy and to monitor any side effects

Primary Outcome Measures: Best overall response [time frame: from the start of treatment until disease progression, up to 2 years]

Principal Investigator: Malcolm Mattes, MD, WVUCI–Mary Babb Randolph Cancer Center; (304) 598-4000, mdmattes@hsc.wvu.edu

ClinicalTrials.gov Identifier: NCT03035890

Study Title: Predictors of Response to Immune Checkpoint Inhibitors in NSCLC and Small Cell Lung Cancer

Study Type: Interventional/single-group assignment

Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center, National Cancer Institute 

Purpose: To study how well bronchoscopy with bronchoalveolar lavage works in identifying biomarkers of response to immune checkpoint inhibitors in patients with non–small cell or small cell lung cancer

Primary Outcome Measures: Biomarker response to immune checkpoint inhibitor therapy as measured by RECIST 1.1 criteria [time frame: up to 24 months]

Principal Investigator: Fabien Maldonado, MD, Vanderbilt-Ingram Cancer Center; contact Vanderbilt-Ingram Service for Timely Access, (800) 811-8480, cip@vanderbilt.edu

ClinicalTrials.gov Identifier: NCT02937402 ■

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.