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

NCT02599454 | Completed Phase 1 DMC FDA Drug

• 4 other identifiers: 774542UCDCC#258ML29955NCI-2015-01796
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stage I Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  The adverse events will be summarized as frequency, proportion of patients MTD. The exact 95% confidence interval for proportion will be categorized by type, severity, nadir or maximum values for the laboratory measures, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities by dose and course.

  9 weeks

Secondary Outcomes (2)

• Disease free survival (DFS), assessed by RECIST 1.1 and irRECIST

  Up to 5 years

• Overall response rate (ORR), assessed by RECIST 1.1

  Time from the start of the treatment until disease progression/recurrence, assessed up to 5 years

Study Arms (1)

atezolizumab + SBRT

EXPERIMENTAL

DOSE ESCALATION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3. EXPANSION PHASE: Patients receive atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Within 24-48 hours after receiving atezolizumab, patients also undergo 4-5 fractions of stereotactic body radiation therapy over days 1-5 of course 3.

Drug: Atezolizumab; Radiation: Stereotactic Body Radiation Therapy

Interventions

Atezolizumab DRUG

Into the vein Day 1 every 3 weeks for 6 cycles

Also known as: MPDL3280A

atezolizumab + SBRT

Stereotactic Body Radiation Therapy RADIATION

Radiation therapy will be performed to 50 Gy over 4 fractions of 12/5 Gy each for peripherally located tumors and 50 Gy over 5 fractions of 10 Gy each for centrally located tumors

Also known as: SBRT

atezolizumab + SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven stage I NSCLC =\< 5 cm diameter
• One or more high-risk features identified:
• Tumor diameter \>= 2 cm
• Tumor standardized uptake value maximum (SUVmax) \>= 6.2
• Moderately, poorly differentiated or undifferentiated histology
• Evaluable disease per RECIST 1.1
• Patients must be medically or surgically inoperable as determined by a physician OR unwilling to undergo surgical resection
• All patients must have an forced expiratory volume in 1 second (FEV1) \>= 700cc
• All patients must have a carbon monoxide diffusing capability test (DLCO) \>= 5.5 m/min/mmHg
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
• Life expectancy \>= 12 months
• Absolute neutrophil count (ANC) \> 1500 cells/uL
• White blood cell count (WBC) \> 2500/uL
• Lymphocyte count \> 500/uL
• Platelet count \> 100,000/uL

You may not qualify if:

• Uncontrolled concomitant disease
• Significant cardiovascular disease (New York Heart Association Class \[NYHA\] class II or greater); myocardial infarction within 3 month prior to randomization, unstable arrhythmias, unstable angina or a patient with a known left ventricular ejection fraction (LVEF) \< 40%
• Severe infection within 4 weeks prior to enrollment
• Active tuberculosis
• Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment
• History of autoimmune disease
• Positive for human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen \[HBsAg\] reactive), or hepatitis C virus (hepatitis C virus ribonucleic acid \[HCV RNA\] \[qualitative\] is detected)
• History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia
• Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
• Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter
• Pregnant and/or lactating women

Sponsors & Collaborators

• Megan Daly, MD: lead
• Genentech, Inc.: collaborator

Study Sites (2)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

David Grant United States Air Force Medical Center

Travis AFB, California, 94535-1800, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Karen Kelly

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: April 26, 2018
• Primary Completion: December 27, 2019
• Study Completion: February 20, 2024
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)