drugset / Trial / NCT02888743

Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer

Phase 2 Active not recruiting 110 enrolled National Cancer Institute (NCI)

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body (metastatic). Immunotherapy with durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.

Timeline

Start: 2017-08-14
Primary completion: 2023-12-31
Completion: 2027-01-02

Outcome

Missed primary endpoint

registry analysis (superiority test); NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT) vs NSCLC Arm C (Tremelimumab, Durvalumab); p = 0.99 NCT02888743 ↗

registry analysis (superiority test); NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT) vs NSCLC Arm C (Tremelimumab, Durvalumab); p = 0.64 NCT02888743 ↗

paper there were no differences in overall response rates between the durvalumab-tremelimumab alone group PMID 35033226 ↗

Publications

Schoenfeld JD, Giobbie-Hurder A, Ranasinghe S, Kao KZ, Lako A, Tsuji J, Liu Y, Brennick RC, Gentzler RD, Lee C, Hubbard J, Arnold SM, Abbruzzese JL, Jabbour SK, Uboha NV, Stephans KL, Johnson JM, Park H, Villaruz LC, Sharon E, Streicher H, Ahmed MM, Lyon H, Cibuskis C, Lennon N, Jhaveri A, Yang L, Altreuter J, Gunasti L, Weirather JL, Mak RH, Awad MM, Rodig SJ, Chen HX, Wu CJ, Monjazeb AM, Hodi FS. Durvalumab plus tremelimumab alone or in combination with low-dose or hypofractionated radiotherapy in metastatic non-small-cell lung cancer refractory to previous PD(L)-1 therapy: an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2022 Feb;23(2):279-291. doi: 10.1016/S1470-2045(21)00658-6. Epub 2022 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	75 mg	Intravenous