Phase 2 Study of Tremelimumab Plus Durvalumab Alone or With Radiation for SCLC
Researchers are evaluating the efficacy of tremelimumab plus durvalumab alone or with radiation therapy among patients with SCLC.
Title: A Randomized Study of Tremelimumab Plus Durvalumab Combination With or Without Radiation in Relapsed Small Cell Lung Cancer1
Principal Investigator: Taofeek K. Owonikoko, MD, PhD, Emory University
Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT02701400), researchers are evaluating the efficacy of tremelimumab plus durvalumab alone or with radiation therapy among patients with small-cell lung cancer (SCLC) who fail first-line therapy.
Patients will be randomly assigned to receive intravenous (IV) tremelimumab and durvalumab over 1 hour on day 1 every 4 weeks for up to 1 year, or stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy for 5 days over 1 week or for 3 fractions every other day for 1 week plus IV tremelimumab and durvalumab.
The primary outcomes are progression-free survival and the objective response rate.
The estimated study enrollment is 20 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact
information, visit https://clinicaltrials.gov/ct2/show/NCT02701400.
Status: Open and recruiting patients as of February 21, 2018.
This study is sponsored by Emory University.
- ClinicalTrials.gov. Tremelimumab and durvalumab with or without radiation therapy in patients with relapsed small cell lung cancer. NCT02701400. https://clinicaltrials.gov/ct2/show/NCT02701400. Accessed February 21, 2018.