Research and Clinical Trials

Cedars-Sinai has one of the largest clinical research trial facilities of any private hospital in the nation. The 164,000-square foot clinical research trial facility is a testament to the medical center's commitment to remain on the forefront of applying research discovery to patient care. The Burns and Allen Research Institute provides a strong scientific, clinical and administration infrastructure to support these investigations. Core facilities funded by a National Institutes of Health grant provide specialized clinical research trial services in a cost-effective, efficient manner.

The Division of Thoracic Surgery believes in the power of research that can directly improve the life of our patients. To search for a clinical trial that may benefit you or someone you know, please click here.

Below are the clinical trials that are currently underway in the Division of Thoracic Surgery:

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY TO ASSESS THE EFFICACY OF RECMAGE-A3 + AS15 ANTIGEN-SPECIFIC CANCER IMMUNOTHERAPEUTIC AS ADJUVANT THERAPY IN PATIENTS WITH RESECTABLE MAGE-A3-POSITIVE NON-SMALL CELL LUNG CANCER
Principal Investigator: Ronald Natale, MD
Co-Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 13809
Study Coordinator and Contact (for screening): Cynthia Martin, (310) 423-2276 Status: Enrolling

Summary: Currently, adjuvant chemotherapy is the standard of care for stage II and IIIA NSCLC, and is also considered for some high risk stage IB NSCLC who have been completely resected. However, many patients receiving chemotherapy will relapse. Because of this high and rapid recurrence rate, the need for alternative therapy for this population, as well as for stage IB to IIIA patients who do not receive chemotherapy for one reason or another. This is a randomized study involving a vaccine to prevent the recurrence of non-small cell lung cancer for patients who test positive for MAGE-A3, a type of protein found in some, but not all, patients with lung cancer.

PRESURGICAL STUDY TO EVALUATE MOLECULAR CHANGES THAT OCCUR IN HUMAN NON-SMALL CELL LUNG CANCER TISSUE AFTER SHORT TERM EXPOSURE TO PF-00299804
Principal Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 20148
Study Coordinator and Contact: Donato Kusuanco, (310) 423-1850
Status: Enrolling

Summary: PF-00299804 is a new type of drug that targets cellular proteins called Human Epidermal Growth Factor Receptors (HER), which appear to play an important role in the pathogenesis and progression of a subset of non-small cell lung cancers. PF-00299804 has demonstrated substantial activity against non-small cell lung cancer in vitro and in vivo. Clinical studies also showed that it is well-tolerated. However, there is limited information about how the drug affects human tissue specimens. Likewise, it is unknown how PF-00299804 alters the expression of the genes involved in regulating tumor cell proliferation, invasion, and metastasis. This study further evaluates the drug’s specific mechanisms at a molecular level.

PROSPECTIVE MULTI-CENTER EVALUATION OF THE ENDO GIA STAPLER WITH ENDO GIA SULU WITH TRI-STAPLE TECHNOLOGY IN A PULMONARY RESECTION
Principal Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 21485
Study Coordinator and Contact: Donato Kusuanco, (310) 423-1850
Status: Enrolling

Summary: Surgical staplers are devices used by surgeons when removing parts of the lung. The Endo GIA SULU with Tri-Staple Technology is one of the new generations of staplers. It uses three rows of staples of varying heights, whereas the standard stapling device uses staples with one consistent height. This study evaluates the efficacy of the stapler in preventing or minimizing the incidence and duration of prolonged air leak (PAL) after a lung resection, as well as in reducing the patient length of stay in the hospital, the rate of complications and the post-operative drainage.

PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY WITH EARLY STAGE NON-SMALL CELL LUNG CANCER ASSOCIATED WITH BANKING OF FROZEN TUMOR SPECIMENS AND COLLECTION OF GENE EXPRESSION PROFILE DATA
Principal Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 21699
Study Coordinator and Contact: Donato Kusuanco, (310) 423-1850
Status: Enrolling

Summary: The purpose of this study is to determine the potential overall survival benefit of adjuvant chemotherapy in early stage NSCLC patients randomized to chemotherapy when compared to those randomized to the present standard of care (observation). The study also allows for the collection of frozen lung cancer tumor tissue for gene expression array generation in order to stratify patients for risk of cancer recurrence and sensitivity to chemotherapy, allowing a more rational method to select appropriate patients for adjuvant chemotherapy.

LUNG CANCER TISSUE BANK
Principal Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 3017
Study Coordinator and Contact: Donato Kusuanco, (310) 423-1850
Status: Enrolling

Summary: The purpose of this study is to collect, catalog and store high-quality frozen samples of lung cancer and when possible, involved lymph nodes, as well as adjacent normal lung tissue obtained from surgical specimens of patients undergoing lung resection for primary lung cancer as a source of quality DNA, mRNA and protein for molecular analysis. With the availability of new expression analysis technologies and a growing panel of molecular tumor markers, there exists unprecedented potential for advances in the detection, diagnosis and classification of tumors, in delineating the biology of oncogenesis and metastasis, and in therapeutic design and outcome prediction.

COLLECTION OF DATA FOR THE SOCIETY OF THORACIC SURGEONS (STS) DATABASE FOR PATIENTS UNDERGOING A CHEST OR LUNG PROCEDURE
Principal Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 4263
Study Coordinator and Contact: Roland Legaspi, (310) 423-3850
Status: Enrolling

Summary: The Society of Thoracic Surgeons (STS) National Database is an extensive data warehouse that was established as an initiative for quality improvement and patient safety, with the corollary potential to be a powerful tool for clinical research.The database allows for: a practice-performance assessment in a risk-adjusted format by comparing local outcomes against regional benchmarks and national standards, analysis of major outcomes and process-of-care measures that impact general thoracic surgery, risk profiles of local patients benchmarked against national standards, feedback to document quality improvement efforts, and data for research projects, including assessment of new technology, which can be used to improve patient care and outcomes.

HUMANITARIAN USE DEVICE: IBV® VALVE SYSTEM HDE# H060002 TO CONTROL PROLONGED AIR LEAKS IN PATIENTS AFTER LOBECTOMY, SEGMENTECTOMY OR LUNG VOLUME REDUCTION SURGERY
Principal Investigator: Robert McKenna, Jr, MD
IRB Approval Number: 18920
Study Coordinator and Contact: Donato Kusuanco, (310) 423-1850
Status: Enrolling

Summary: The standard management of air leaks due to persistent air leak involves using tubes placed in the chest to drain the air, using surgical glues or sealants and a surgical procedure called pleurodesis. For cases that are harder to manage, surgical repair maybe required. However, some of these patients may be at high risk for surgery, particularly if they have already had thoracic surgery or have other medical problems; for this group there is a need for less invasive methods of stopping or reducing air leaks. The IBV Valve System has been used in a few patients with prolonged large air leak (air leak that is apparent under normal breathing and that lasts more than 7 days). The FDA has approved a humanitarian device exemption (HDE) for the IBV Valve System so that it can be used for controlling prolonged large air leak after a lobectomy, segmentectomy or lung volume reduction surgery.