Abstract | INTRODUCTION: MATERIALS AND METHODS: Alliance A082002 is based on subgroup analysis from the randomized phase II PEMBRO-RT trial., PEMBRO-RT compared pembrolizumab alone or with SBRT and revealed improved progression-free and overall survival (PFS and OS, respectively) in PD-L1(-) patients when adding SBRT (8 Gy x 3 fractions). In A082002, patients without PD-L1 expression will be randomized to SBRT (8 Gy x3) plus systemic therapy vs. systemic therapy alone. The primary endpoint of the phase II portion of the trial is PFS and will require 100 patients. The primary endpoint of the phase III portion of the trial is OS and will require an additional 284 patients. This trial will clarify whether adding SBRT to systemic therapy can improve PFS and OS in a larger multi-institutional cohort. Several systemic treatment options are allowed including either immunotherapy alone or chemo- immunotherapy. CONCLUSIONS: This phase II/III Alliance trial A082002 will test whether the addition of SBRT to a single tumor site will enhance the anti- tumor activity of systemic immunotherapy or chemo- immunotherapy in patients with stage IV PD-L1(-) NSCLC. It is now open in the National Clinical Trials Network (NCTN).
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Authors | Steven E Schild, Xiaofei Wang, Christine M Bestvina, Terence Williams, Greg Masters, Anurag K Singh, Thomas E Stinchcombe, Joseph K Salama, Steven Wolf, Tyler Zemla, Narjust Duma, Stephen G Chun, Arya Amini, David Kozono, Colleen Watt |
Journal | Clinical lung cancer
(Clin Lung Cancer)
Vol. 23
Issue 5
Pg. e317-e320
(07 2022)
ISSN: 1938-0690 [Electronic] United States |
PMID | 35613998
(Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Copyright | Copyright © 2022 Elsevier Inc. All rights reserved. |
Chemical References |
- B7-H1 Antigen
- CD274 protein, human
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Topics |
- B7-H1 Antigen
- Carcinoma, Non-Small-Cell Lung
(drug therapy)
- Humans
- Immunotherapy
- Lung Neoplasms
(drug therapy)
- Radiosurgery
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