The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of people with lung neoplasms, including stage I and II small cell and non–small cell lung cancers. The studies include phase Ib, II, III, observational, and interventional trials evaluating combinations of therapies; molecular predictors of lung cancer; molecular strategies for early detection; guided radiation therapy; genetic epidemiology; immunoregulation of lung cancer by NK cells; surgery; and DNA/RNA sequencing to predict treatment response. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE Ib/II
Study Type: Phase Ib/II/interventional/single-group assignment
Study Title: Phase Ib/II Trial of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies (Phase Ib) and Small Cell Lung Cancer Patients (Phase II) Who Have Progressed on Prior Platinum-Based Chemotherapy
Study Sponsor and Collaborators: Cancer Research and Biostatistics Clinical Trials Consortium, Lucille P. Markey Cancer Center at the University of Kentucky, Washington University School of Medicine
Purpose: To determine a well-tolerated dose of carfilzomib (Kyprolis) in combination with irinotecan in subjects with relapsed small cell and non–small cell lung cancer or other irinotecan-sensitive cancers and to assess the 6-month survival of relapsed small cell lung cancer patients treated with this combination therapy
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Phase Ib: Determine maximum tolerated dose of carflizomib in combination with irinotecan in subjects with relapsed small and non–small cell lung cancer or other irinotecan-sensitive cancers (time frame: 28 days). Phase II: Assess 6-month survival of relapsed small cell lung cancer patients treated with carfilzomib in combination with irinotecan (time frame: up to 6 months).
Principal Investigator: Susanne M. Arnold, MD, Lucille P. Markey Cancer Center at the University of Kentucky; 859-323-8043, smarno0@uky.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01941316
PHASE II
Study Type: Phase II/interventional/randomized
Study Title: Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non–Small Cell Lung Cancer (NSCLC)
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study how well positron-emission tomography/computer tomography scan works in guiding radiation therapy compared to standard therapy treatment in patients with stage III non–small cell lung cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Local-regional, progression-free rate (time frame: 2 years)
Principal Investigator: Feng-Ming (Spring) P. Kong, Radiation Therapy Oncology Group; 706-721-1663, cancer@georgiahealth.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01507428
Study Type: Phase II/interventional/single-group assignment
Study Title: STEREOtactic Radiation and Adjuvant Chemotherapy in Lung Cancer (STEREO)
Study Sponsor and Collaborators: James Graham Brown Cancer Center
Purpose: To test the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non–small cell lung cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To measure the feasibility of adjuvant chemotherapy after stereotactic body radiation therapy for early stage non–small cell lung cancer (time frame: 3 years after subject enrollment)
Principal Investigator: Goetz H. Kloecker, MD; 502-562-4358, ghkloe01@louisville.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01300299
Study Type: Phase II/interventional/nonrandomized
Study Title: Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non–Small Cell Lung Cancer
Study Sponsor and Collaborators: University of Florida
Purpose: To determine whether hypofractionated image-guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early-stage lung tumors for patients who will not have surgery
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Confirm grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non–small cell lung cancer (time frame: 1 year after the end of radiation therapy)
Principal Investigator: Bradford S. Hoppe, MD, MPH, University of Florida Proton Therapy Institute; contact Intake Coordinator, 877-686-6009
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00875901
PHASE III
Study Type: Phase III/interventional/randomized
Study Title: A Phase III, Multicentre, Randomized Trial to Evaluate the Symptomatic and Quality of Life Improvements in Lung Cancer Patients Receiving External Beam Radiation With or Without High-Dose Rate Intraluminal Brachytherapy
Study Sponsor and Collaborators: Ontario Clinical Oncology Group, Canadian Cancer Society Research Institute
Purpose: To improve the quality of life of patients with advanced non–small cell lung cancer by evaluating the symptomatic improvement in patients with lung cancer receiving external radiation with or without high-dose internal radiation
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: For each subject, a lung cancer-related symptomatic improvement at 6 weeks postrandomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms (time frame: 6 weeks from randomization)
Principal Investigator: Ranjan Sur, MD, PhD, Juravinski Cancer Centre; contact Jim Wright, 905-387-9495, ext. 64706; jim.wright@jcc.hhsc.ca
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01351116
OBSERVATIONAL
Study Type: Observational
Study Title: Molecular Predictors of Lung Cancer Behavior
Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center
Purpose: To investigate molecular predictors of cancer in patients at high risk for developing lung cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To quantitate the molecular changes during lung cancer development (time frame: after collection of designated samples)
Principal Investigator: Pierre Massion, MD, Vanderbilt-Ingram Cancer Center; contact Rena Burns, RN; 615-873-7658, rena.burns@va.gov
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00898313
Study Type: Observational
Study Title: Genetic Epidemiology of Lung Cancer
Study Sponsor and Collaborators: National Human Genome Research Institute
Purpose: This study will search for genes that greatly increase the risk of developing lung cancer in conjunction with cigarette smoking or other environmental agents, or both. While lung cancer has been frequently cited as an example of cancer determined only by the environment, certain occupations, and dietary habits, researchers have long had a hypothesis that people vary in their risk of becoming affected when exposed to these factors. Also, some evidence has shown that lung cancer in families may be due to the combined effects of inheritance of a major gene and cigarette smoking. Individuals with a confirmed diagnosis of lung cancer or a family history of lung cancer may be eligible to enroll their families in this study.
Ages Eligible for Study: 5 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: Yes
Primary Outcome Measures: Detection of gene(s) contributing to lung cancer risk
Principal Investigator: Joan Bailey-Wilson, PhD, National Human Genome Research Institute; 443-740-2921, jebw@nhgri.nih.gov
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00341835
Study Type: Observational
Study Title: Mechanisms of Immunosurveillance for Lung Cancer
Study Sponsor and Collaborators: Washington University School of Medicine, Saint Louis VA Medical Center
Purpose: To investigate the differences in natural killer (NK) blood cells, a type of white blood cell that fights infection in the body, among different types of patients who have lung surgery. The four different groups of patients include smokers with lung cancer, smokers without lung cancer, nonsmokers with lung cancer, and nonsmokers without lung cancer.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: Yes
Primary Outcome Measures: Number of NK cells (time frame: within 5 minutes of blood arrival to lab, processing begins, and blood is frozen; flow cytometry will be completed 1 to 3 months after blood is frozen; data presentation in 1 to 2 years)
Principal Investigator: Alexander S. Krupnick, MD, Washington University School of Medicine; contact Joanne F. Musick, BSN; 314-747-0707, musickj@wudosis.wustl.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01710319
Study Type: Observational
Study Title: Molecular Fingerprinting of Lung Cancer
Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center, National Cancer Institute
Purpose: To collect and analyze lung tissue samples from patients undergoing surgery for non–small cell lung cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Protein and RNA expression fingerprints from collected samples (time frame: after collection of designated samples)
Principal Investigator: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center; contact VICC Clinical Trials Information Program, 800-811-8480
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00897117
Study Type: Observational
Study Title: Nashville Early Diagnosis Lung Cancer Project
Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center, National Cancer Institute
Purpose: This screening will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiologic and imaging strategies. The goal of the investigators is to provide screening for lung cancer in a high-risk population. This study will test whether repeated measure of biomarkers of risk allows early detection of lung cancer.
Ages Eligible for Study: 55 to 74 years
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To compare candidate biomarkers over time among participants who did and did not develop lung cancer (time frame: at baseline and yearly to year 5)
Principal Investigator: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center; contact Anel Muterspaugh, 615-936-4244
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01475500
Study Type: Observational
Study Title: Specimen Banking From Patients With Lung Cancer
Study Sponsor and Collaborators: University of Colorado, Denver; National Cancer Institute
Purpose: To develop a comprehensive specimen banking program from patients with lung cancer for future translational research, which will enable the investigators to detect lung cancer earlier, develop better therapies and explore screening and prevention strategies
Ages Eligible for Study: 18 to 85 years
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To develop a comprehensive specimen banking program from patients with lung cancer for future translational research (time frame: 6 years)
Principal Investigator: Wilbur Franklin, MD, University of Colorado, Denver; contact Mary K. Jackson; 303-724-1650, mary.k.jackson@ucdenver.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01585675
Study Type: Observational
Study Title: Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy
Study Sponsor and Collaborators: Vanderbilt-Ingram Cancer Center; National Cancer Institute
Purpose: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help investigators learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help clinicians predict how patients will respond to treatment.
Ages Eligible for Study: N/A
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: DNA, RNA, and protein expression patterns and mutational analysis (time frame: after lung tumor tissue and blood collection)
Principal Investigator: Christine Lovly, MD, PhD, Vanderbilt-Ingram Cancer Center; contact VICC Clinical Trial Information Program, 800-811-8480
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00897650
INTERVENTIONAL
Study Type: Interventional/single-group assignment
Study Title: Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non–Small Cell Lung Cancer
Study Sponsor and Collaborators: Jonsson Comprehensive Cancer Center
Purpose: To study image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II–III non–small cell lung cancer that cannot be removed by surgery. Giving RT together with combination chemotherapy may kill tumor cells and allow doctors to save the part of the body where the cancer started.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II–III non–small cell lung cancer (time frame: up to 90 days)
Principal Investigator: Percy Lee, MD, Jonsson Comprehensive Cancer Center; 310-825-9771
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01345851 ■
