Clinical Trials Actively Recruiting Patients With Lung Cancer

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with lung cancer. The trials are investigating DNA, RNA, and protein changes contributing to carcinogenesis; new prevention strategies; combination therapies; radiation, stereotactic, and proton therapy; and surgical measures. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

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: To evaluate changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer

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; 800-811-8480

For More Information: Use ClinicalTrials.gov Identifier NCT00897650

Study Type: Phase I/Interventional/Single-Group Assignment

Study Title: A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer

Study Sponsor and Collaborators: Roswell Park Cancer Institute, National Cancer Institute

Purpose: To study the side effects and best dose of calcitriol in preventing lung cancer in current smokers and former smokers at high risk of lung cancer

Primary Outcome Measures: Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks [time frame: 3 months]

Principal Investigator: Alex A. Adjei, MD, PhD, Roswell Park Cancer Institute; contact 877-275-7724, AskRPCI@RoswellPark.org

For More Information: Use ClinicalTrials.gov Identifier NCT00690924

Study Type: Phase I/II/Interventional/Single-Group Assignment

Study Title: Phase 1b/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 University of Kentucky, Washington University School of Medicine

Purpose: To determine a well-tolerated dose of carfilzomib in combination with irinotecan in subjects with relapsed small 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

Primary Outcome Measures: Phase 1b: Determine maximum tolerated dose of carfilzomib 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; 859-323-8043, ­smarno0@uky.edu.

For More Information: Use ClinicalTrials.gov Identifier  NCT01941316

Study Type: Phase II/Interventional/Parallel Assignment

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 if 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

Primary Outcome Measures: Confirm grade III 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; 877-686-6009

For More Information: Use ClinicalTrials.gov Identifier NCT00875901

Study Type: Phase II/III/Interventional/Single Group Assignment

Study Title: STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non–Small Cell Lung Cancer Patients Who Can Undergo Lobectomy

Study Sponsor and Collaborators: MD Anderson Cancer Center

Purpose: To evaluate the outcome of a standard radiation treatment called stereotactic radiotherapy (SRT) for non–small cell lung cancer, specifically, to learn if standard SRT has as good of an outcome at 3 years after the ­procedure.

Primary Outcome Measures: Overall survival for stage I non–small cell lung cancer patients treated with stereotactic body radiotherapy [time frame: 3 years]

Principal Investigator: Jack Roth, MD, BA, MD Anderson Cancer Center; 713-563-9152

For More Information: Use ClinicalTrials.gov Identifier NCT02357992

Study Type: Phase III/Interventional/Parallel Assignment

Study Title: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Study Sponsor and Collaborators: Alliance for Clinical Trials in Oncology, National Cancer Institute

Purpose: To compare different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer

Primary Outcome Measures: Overall survival time between 3 treatment arms [time frame: up to 5 years]

Principal Investigator: Jeffery A. Bogart, MD, SUNY Upstate Medical University; 315-464-5276

For More Information: Use ClinicalTrials.gov Identifier NCT00632853  ■