NCT02599454

Atezolizumab and Stereotactic Body Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

Completed Phase 1 Last updated 27 October 2025

What this trial tests

Phase 1 trial testing Atezolizumab in Stage I Non-Small Cell Lung Cancer in 20 participants. Completed in 20 February 2024.

Timeline

26 April 2018

Primary endpoint
27 December 2019

20 February 2024

Quick facts

Lead sponsor	Megan Daly, MD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	26 April 2018
Primary completion	27 December 2019
Estimated completion	20 February 2024
Sites	2 locations across United States

Drugs / interventions tested

• Atezolizumab (atezolizumab) — full drug profile →
• Stereotactic Body Radiation Therapy — full drug profile →

Conditions studied

• Stage I Non-Small Cell Lung Cancer — all drugs for Stage I Non-Small Cell Lung Cancer →

Sponsor

Megan Daly, MD — full company profile →

Who can join

18 and older, any sex, with Stage I Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of atezolizumab that can be given together with stereotactic body radiation therapy (SBRT) in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery. Monoclonal antibodies, such as atezolizumab, 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. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Giving atezolizumab together with stereotactic body radiation therapy may kill more tumor cells and be a better treatment for non-small cell lung cancer that cannot be removed by surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combination therapy with immune checkpoint inhibitors (ICIs); a new frontier.
   Vafaei S, Zekiy AO, Khanamir RA, Zaman BA, et al · · 2022 · cited 190× · PMID 34980128 · DOI 10.1186/s12935-021-02407-8
2. SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges.
   Chen Y, Gao M, Huang Z, Yu J, et al · · 2020 · cited 125× · PMID 32723363 · DOI 10.1186/s13045-020-00940-z
3. Clinical Outcomes in Patients With Metastatic Lung Cancer Treated With PD-1/PD-L1 Inhibitors and Thoracic Radiotherapy.
   Hwang WL, Niemierko A, Hwang KL, Hubbeling H, et al · · 2018 · cited 74× · PMID 28973343 · DOI 10.1001/jamaoncol.2017.3808
4. Trial Watch: Immunotherapy plus radiation therapy for oncological indications.
   Vacchelli E, Bloy N, Aranda F, Buqué A, et al · · 2016 · cited 61× · PMID 27757313 · DOI 10.1080/2162402x.2016.1214790
5. Current Clinical Progress of PD-1/PD-L1 Immunotherapy and Potential Combination Treatment in Non-Small Cell Lung Cancer.
   Li JX, Huang JM, Jiang ZB, Li RZ, et al · · 2019 · cited 45× · PMID 31838881 · DOI 10.1177/1534735419890020
6. The evolving toxicity profile of SBRT for lung cancer.
   Thompson M, Rosenzweig KE. · · 2019 · cited 45× · PMID 30788234 · DOI 10.21037/tlcr.2018.10.06
7. Atezolizumab for the treatment of non-small cell lung cancer.
   Santini FC, Rudin CM. · · 2017 · cited 37× · PMID 28714780 · DOI 10.1080/17512433.2017.1356717
8. Proton beam therapy and immunotherapy: an emerging partnership for immune activation in non-small cell lung cancer.
   Lee HJ, Zeng J, Rengan R. · · 2018 · cited 32× · PMID 29876317 · DOI 10.21037/tlcr.2018.03.28