Scott & White Healthcare in Round Rock, Texas is recruiting patients for a Phase III lung cancer trial aimed at preventing the disease's recurrence in previously treated patients. The trial will evaluate the potential of an immunotherapy called Antigen-Specific Cancer Immunotherapeutic (ASCI) for the treatment of Non-Small Cell Lung Cancer (NSCLC).

The MAGRIT (MAGE-A3 as Adjuvant Non-Small Cell LunG Cancer Immunotherapy) study is expected to be one of the largest Phase III trials ever conducted for NSCLC. Scott & White Healthcare - Round Rock is joining with 400 centers in more than 33 countries worldwide in this clinical research effort.

"The randomized, double-blind, placebo-controlled trial will enroll patients that demonstrate the MAGE-A3 biomarker and those who are assessed as stage IB, II, or IIIA resectable Non-Small Cell Lung Cancer," said Laura Beaty, M.D., principal investigator and hematology/oncologist at Scott & White Healthcare - Round Rock. "The ASCI administration will be started in patients after surgery and standard chemotherapy, and in patients who only receive surgery as a standard of care as the primary endpoint of the trial is disease-free survival," she said.

ASCI is an investigational class of cancer immunotherapy agents aimed at educating the patient's immune system to identify cancer cells in a specific manner. This investigational cancer immunotherapy is developed using tumor-specific antigens. "If a patient's cancer is found to express certain proteins/antigens, then the treatment educates their immune system to fight their cancer cells," explained Dr. Beaty.

"This study is a global undertaking and we are looking for patients to consider enrolling," said Dr. Beaty. "To reach our enrolment target of 2,270 patients, we'll need to screen more than 13,000 patients worldwide."

The trial has a target enrolment of 2,270 patients. For patients who are interested in this trial, please contact Jill Meredith, RN, OCN, CCRP or MeLissa Carney, CCRP, Scott & White Healthcare - Round Rock. Additional information can be found here.

About the Phase II NSCLC trial

The Phase II double-blind, placebo-controlled study is believed to be the first positive proof-of-concept for an ASCI in early Non-Small Cell Lung Cancer (NSCLC). The study randomized 182 patients with completely resected stages IB or II NSCLC to receive either MAGE-A3 ASCI or placebo in the adjuvant setting. All patients participating in the trial had cancers expressing a tumor-specific antigen known as MAGE-A3, which is present in approximately 35 percent to 50 percent of early NSCLC.1

In the Phase II clinical study, the most commonly reported adverse events were mild local (pain, redness, swelling) or systemic (fever, fatigue, muscle pain) reactions. Out of 182 patients, only three Grade 3 adverse events were rated as possibly related to the MAGE-A3 treatment. These events led to the withdrawal of only one patient for chronic obstructive pulmonary disease (COPD) exacerbation.

About MAGE-A3 ASCI

MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers with no expression in normal cells. The antigen has been found in about 30-50% of lung cancer patients. The high expression of MAGE-A3 in non-small cell lung cancer, as well as the high unmet medical need in this disease population prompted the development of the study ASCI antigen targeting the MAGE-A3.

MAGE-A3 ASCI is an investigational compound and it is not approved for use in any indication in any country at this time.

About Non-Small Cell Lung Cancer

According to the World Health Organization (WHO), more than 1.2 million new cases of lung and bronchus cancer are diagnosed each year worldwide. There were 386,300 new cases of lung cancer in Europe2 and 174,000 new cases of lung cancer in the U.S. in 2006 and 334,800 (Europe), 162,000 (U.S.) related deaths in the same year, causing lung cancer to remain the biggest killer in Europe.

Source:
Katherine Voss Scott & White Healthcare