The Bend Memorial Clinic is recruiting patients for a Phase III lung cancer trial aimed at preventing the disease’s recurrence in previously treated patients. Specifically, the trial is evaluating the potential of an immunotherapy called Antigen-Specific Cancer Immunotherapeutic (ASCI) for the treatment of Non-Small Cell Lung Cancer (NSCLC).
The study, entitled MAGRIT (MAGE-A3 as Adjuvant Non-Small Cell LunG Cancer Immunotherapy), is expected to be one of the largest Phase III trials ever conducted in NSCLC. Bend Memorial Clinic will join some 400 centers in more than 33 countries worldwide in this clinical research effort.
MAGE-A3 ASCI is an investigational compound and it is not approved for use in any indication in any country at this time. With a target enrolment of 2,270 patients, the randomized, double-blind, and placebo-controlled MAGRIT trial will enroll patients who demonstrate the MAGE-A3 biomarker and who are assessed as stage IB, II or IIIA resectable NSCLC. The ASCI administration will be initiated in patients after surgery and standard chemotherapy, and also in patients who only receive surgery as a standard of care. The primary endpoint of the trial is disease-free survival.
ASCI is an investigational class of cancer immunotherapy agent 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.
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.
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.
“This study is a global undertaking and we really are looking for patients to consider enrolling,” said Bill Schimdt, oncologist at Bend Memorial Clinic. “To reach our enrolment target of 2,270 patients, we’ll need to screen more than 13,000 patients worldwide. The Bend Memorial Clinic is an active player in this trial and we are seeking patients to take part.”
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 Europe and 174,000 new cases of lung cancer in the United States in 2006 and 334,800 (Europe), 162,000 (United States) related deaths in the same year, causing lung cancer to remain the biggest killer in Europe.