Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
NCT04092283 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 660
Last updated 2026-05-01
Summary
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.
Conditions
- Recurrent Lung Non-Small Cell Carcinoma
- Stage III Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Unresectable Lung Non-Small Cell Carcinoma
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- BIOLOGICAL
-
Given IV
- DRUG
-
Etoposide
Given IV
- DRUG
-
Given IV
- DRUG
-
Pemetrexed Disodium
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Nathan A Pennell · ECOG-ACRIN Cancer Research Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-29
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
- Guam
Study Locations
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