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Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer.

Publication ,  Journal Article
Schild, SE; Wang, X; Bestvina, CM; Williams, T; Masters, G; Singh, AK; Stinchcombe, TE; Salama, JK; Wolf, S; Zemla, T; Duma, N; Chun, SG ...
Published in: Clin Lung Cancer
July 2022

INTRODUCTION: Treatment of advanced stage non-small cell lung cancer (NSCLC) has changed dramatically due to immunotherapy. However, patients without Programmed Death-Ligand 1 (PD-L1) protein expression often benefit less from immunotherapy. This trial is designed to test if stereotactic body radiation therapy (SBRT) to a single tumor site can significantly enhance the outcome of patients with advanced stage PD-L1(-) NSCLC when added to systemic therapy including immunotherapy. 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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Published In

Clin Lung Cancer

DOI

EISSN

1938-0690

Publication Date

July 2022

Volume

23

Issue

5

Start / End Page

e317 / e320

Location

United States

Related Subject Headings

  • Radiosurgery
  • Oncology & Carcinogenesis
  • Lung Neoplasms
  • Immunotherapy
  • Humans
  • Carcinoma, Non-Small-Cell Lung
  • B7-H1 Antigen
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
  • 1112 Oncology and Carcinogenesis
 

Citation

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Schild, S. E., Wang, X., Bestvina, C. M., Williams, T., Masters, G., Singh, A. K., … Watt, C. (2022). Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer. Clin Lung Cancer, 23(5), e317–e320. https://doi.org/10.1016/j.cllc.2022.04.004
Schild, Steven E., Xiaofei Wang, Christine M. Bestvina, Terence Williams, Greg Masters, Anurag K. Singh, Thomas E. Stinchcombe, et al. “Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer.Clin Lung Cancer 23, no. 5 (July 2022): e317–20. https://doi.org/10.1016/j.cllc.2022.04.004.
Schild SE, Wang X, Bestvina CM, Williams T, Masters G, Singh AK, et al. Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer. Clin Lung Cancer. 2022 Jul;23(5):e317–20.
Schild, Steven E., et al. “Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer.Clin Lung Cancer, vol. 23, no. 5, July 2022, pp. e317–20. Pubmed, doi:10.1016/j.cllc.2022.04.004.
Schild SE, Wang X, Bestvina CM, Williams T, Masters G, Singh AK, Stinchcombe TE, Salama JK, Wolf S, Zemla T, Duma N, Chun SG, Amini A, Kozono D, Watt C. Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer. Clin Lung Cancer. 2022 Jul;23(5):e317–e320.
Journal cover image

Published In

Clin Lung Cancer

DOI

EISSN

1938-0690

Publication Date

July 2022

Volume

23

Issue

5

Start / End Page

e317 / e320

Location

United States

Related Subject Headings

  • Radiosurgery
  • Oncology & Carcinogenesis
  • Lung Neoplasms
  • Immunotherapy
  • Humans
  • Carcinoma, Non-Small-Cell Lung
  • B7-H1 Antigen
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
  • 1112 Oncology and Carcinogenesis