Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

Conditions

• Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• Fludeoxyglucose F-18 — OTHER
  Undergo FDG PET/CT
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT

Study Details

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Key Dates

Start date

Aug 13, 2020

Status verified

Jun 2026

Primary completion

Aug 24, 2024

Completion

Jun 9, 2027

Study Design

Enrollment

415 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (atezolizumab, SBRT)
  Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.
• Active Comparator: Arm B (SBRT)
  Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days or QD over 1-3 weeks. Patients undergo FDG-PET/CT during screening. Patients undergo blood sample collection and CT scans throughout the trial.

Primary Outcome Measure

Overall survival [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 3 years ]

Locations (391)

Find similar trials in Anchorage, AK

Related Studies

• Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
  PHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
  PHASE2 · Recruiting · Roswell Park Cancer Institute · Buffalo, New York
• Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
  PHASE3 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska