THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with lung cancer. These studies highlight combinations of chemotherapy, mutation-specific treatments, stereotactic body radiation therapy, metastatic control, cancer staging, and performance status–tailored treatment. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Phase I Study of Tetrathiomolybdate in Combination With Carboplatin and Pemetrexed in Chemotherapy-Naive Metastatic or Recurrent Nonsquamous Non–Small Cell Lung Cancer (NSCLC)
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: University of Rochester
Purpose: To determine the recommended phase II dose and safety of tetrathiomolybdate in combination with carboplatin and pemetrexed in chemotherapy-naive metastatic or recurrent nonsquamous NSCLC
Primary Outcome Measures: Number of participants with adverse events as a measure of safety and tolerability [time frame: 3 years]
Principal Investigator: David Dougherty, MD, University of Rochester; (585) 275-0394, david_dougherty@urmc.rochester.edu
ClinicalTrials.gov Identifier: NCT01837329
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Study Title: A Phase IB Study of AZD9291 in Combination With Navitoclax in EGFR-Mutant NSCLC Following Resistance to Initial Epidermal Growth Factor Receptor (EGFR) Kinase Inhibitor
Study Type: Phase I/interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated metastatic EGFR-positive NSCLC or metastatic EGFR-positive NSCLC that has not responded to previous treatment with an initial EGFR kinase inhibitor
Primary Outcome Measures: Feasibility of the combination therapy in T790M-positive lung cancer, measured as at least 50% of patients achieving the expected dose duration and intensity (dose expansion) [time frame: up to 12 weeks (3 courses of treatment)]; incidence of toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (dose escalation) [time frame: up to 2 years]
Principal Investigator: Geoffrey Oxnard, MD, Dana-Farber Cancer Institute; see clinicaltrials.gov for contact information for each participating location
ClinicalTrials.gov Identifier: NCT02520778
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Study Title: Stereotactic Body Radiation Therapy for Inoperable Locally Advanced NSCLC
Study Type: Phase I/interventional/parallel assignment
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To determine whether the use of exploratory immunologic biomarkers and functional magnetic resonance imaging can serve as early predictors for response in NSCLC
Primary Outcome Measures: Maximum tolerated dose (cohort A) [time frame: 2 years]
Principal Investigator: Andreas Rimmer, MD, Memorial Sloan Kettering Cancer Center; (212) 639-6025
ClinicalTrials.gov Identifier: NCT01899989
PHASE II
Study Title: A Phase II Study of Lorlatinib (PF-06463922) in Advanced Anaplastic Lymphoma Kinase (ALK) and ROS Proto-Oncogene 1 (ROS1)-Rearranged NSCLC With Central Nervous System Metastasis in the Absence of Measurable Extracranial Lesions
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Massachusetts General Hospital
Purpose: To study lorlatinib as a possible treatment for ALK-positive or ROS1-positive NSCLC
Primary Outcome Measures: Intracranial disease control rate [time frame: 12 weeks]
Principal Investigator: Alice T. Shaw, MD, PhD, Massachusetts General Hospital; (617) 724-4000
ClinicalTrials.gov Identifier: NCT02927340
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Study Title: A Pilot Study Evaluating Pemetrexed in Eastern Cooperative Oncology Group (ECOG) Performance Status 3 Patients With Stage IV Nonsquamous NSCLC
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: Wake Forest University Health Sciences, National Cancer Institute
Purpose: To study how well pemetrexed disodium works in treating patients with stage IV NSCLC and an ECOG performance status of 3. Pemetrexed disodium causes fewer side effects than many chemotherapy drugs and may help treat patients with stage IV NSCLC and a lower performance status.
Primary Outcome Measures: Change in quality of life, assessed by the European Organisation for Research and Treatment (EORTC) Quality-of-Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item [time frame: baseline to 12 weeks]; time to tumor progression [time frame: the duration of time from the start of treatment to the time of tumor progression, death, or date of last contact, assessed up to 2 years]
Principal Investigator: Stefan Grant, MD, JD; (336) 713-5172, scgrant@wakehealth.edu
ClinicalTrials.gov Identifier: NCT02426658
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Study Title: A Single-Arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection
Study Type: Phase II/interventional/single-group assignment
Study Sponsor and Collaborators: University of Kentucky
Purpose: To study patients undergoing video-assisted thoracoscopic resection of lung cancer receiving standard therapy including lobectomy or sublobar resection and mediastinal lymph node dissection. After completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes that may appear pathologic on ultrasound evaluation.
Primary Outcome Measures: Rate of detection of occult pathologic N2 lymph nodes [time frame: at the time of surgery]
Principal Investigator: Angela Mahan, MD, University of Kentucky; angela.mahan@uky.edu
ClinicalTrials.gov Identifier: NCT02218242 ■
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.
