ASTRO 2020: Stereotactic Body Radiotherapy With and Without Pembrolizumab Under Study in Lung Cancer
Posted: Friday, November 13, 2020
The ongoing KEYNOTE-867 trial will provide important information regarding the safety and efficacy of stereotactic body radiotherapy with or without pembrolizumab among patients with inoperable stage I/IIA non–small cell lung cancer (NSCLC). The study design was presented by Salma K. Jabbour, MD, of Rutgers Cancer Institute of New Jersey, at the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 2301).
This phase III randomized control trial aims to recruit approximately 530 patients with previously untreated, medically inoperable stage I/IIA NSCLC. Patients will be randomly assigned 1:1 to receive thoracic stereotactic body radiotherapy to their primary tumors for up to 2 weeks plus either 200 mg of pembrolizumab or placebo every 3 weeks for a total of 17 cycles (approximately 1 year). Peripheral tumors will be treated using 3 x 15 Gy or 3 x 18 Gy fractions; tumors abutting the chest wall will be treated with 4 x 12 Gy or 5 x 10 Gy fractions; central tumors will receive 5 x 10 Gy fractions. Treatment will be discontinued in a participant if there is disease recurrence, development of unacceptable adverse events, or study withdrawal/noncompliance. Patient images will be assessed by a blinded independent central reviewer at 12 weeks (10 weeks after radiotherapy), followed by every 16 weeks for 3 years, then every 6 months.
The primary endpoints being assessed are event-free survival according to blinded independent central review and overall survival; evaluation will be performed using a nonparametric Kaplan-Meier method. Other data to be assessed will include the time to death or distant metastases, safety, the time to subsequent treatment, disease-specific survival, and the time to recurrence/disease progression on a subsequent line of therapy.
Adverse events will be monitored throughout the trial and for 30 days after patients receive their last dose (90 days for serious adverse events). Enrollment in the trial was initiated in June 2019 in 131 sites across the United States, Canada, Europe, Asia, South America, Russia, Australia, and New Zealand.
Disclosure: For disclosures for Dr. Jabbour, visit plan.core-apps.com.