Phase 2 Study of Tremelimumab Plus Durvalumab Alone or With Radiation for 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.

Reference

1. 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.