New combo therapy aims to stop early lung cancer from returning

NCT ID NCT03833154

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding the immunotherapy drug durvalumab to standard radiation therapy helps prevent early-stage non-small cell lung cancer from progressing. It includes about 724 patients who cannot have surgery. A separate group of patients with a specific EGFR gene mutation will receive the targeted pill osimertinib after radiation. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: durvalumab (an immunotherapy drug) and osimertinib (a targeted therapy pill)
What this could lead to: If it works, this could offer a new treatment option that helps keep early-stage lung cancer from coming back after radiation therapy.
What could go wrong: This is still being tested, so it is not yet proven to work. Immunotherapy can cause immune-related side effects, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

724 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Cohort Key Inclusion Criteria: 1. Age ≥18 years 2. Planned SoC SBRT as definitive treatment 3. World Health Organization (WHO)/ECOG PS of 0, 1 or 2 4. Life expectancy of at least 12 weeks 5. Body weight \>30 kg 6. Submission of tumor tissue sample if available 7. Adequate organ and marrow function required 8. Patients with central or peripheral lesions are eligible 9. Staging studies must be done during screening (PET-CT within 10 weeks) 10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions Main Cohort Key Exclusion Criteria: 1. Mixed small cell and non-small cell cancer 2. History of allogeneic organ transplantation 3. History of another primary malignancy with exceptions 4. History of active primary immunodeficiency 5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort 6. Prior exposure to immune-mediated therapy with exceptions Osimertinib Cohort Key Inclusion Criteria 1. Age ≥18 years 2. Planned SoC SBRT as definitive treatment 3. WHO/ECOG PS of 0, 1, or 2 4. Patients with central or peripheral lesions are eligible 5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions 6. Staging studies must be done during screening (PET-CT within 10 weeks) 7. Submission of tumor tissue sample if available 8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R) 9. Adequate bone marrow reserve or organ function required 10. Female patients should be using highly effective contraceptive measures 11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation Osimertinib Cohort Key Exclusion Criteria 1. Mixed small cell and non-small cell cancer 2. Patients with known or increased risk factor for QTc prolongation 3. Treatment with any of the following: * Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation * Prior treatment with neoadjuvant or adjuvant EGFR TKI * Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib 5. Any of the following cardiac criteria * Mean resting corrected QT interval \>470 msec, obtained from 3 ECGs * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval * Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

Research Site

Tuscaloosa, Alabama, 35401, United States
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Chandler, Arizona, 85224, United States
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Phoenix, Arizona, 85004, United States
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Tucson, Arizona, 85719, United States
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Duarte, California, 91010, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90095, United States
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San Diego, California, 92123, United States
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Newark, Delaware, 10709, United States
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Washington D.C., District of Columbia, 20010, United States
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Bay Pines, Florida, 33744, United States
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Jacksonville, Florida, 32256, United States
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Miami Beach, Florida, 33140, United States
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Orlando, Florida, 32804, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30342, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Decatur, Illinois, 62526, United States
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Elmhurst, Illinois, 60126, United States
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Naperville, Illinois, 60540, United States
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Fort Wayne, Indiana, 46845, United States
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Cedar Rapids, Iowa, 52403, United States
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Iowa City, Iowa, 52242, United States
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Elizabethtown, Kentucky, 42701, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40202, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70121, United States
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South Portland, Maine, 04106, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Rosedale, Maryland, 21237, United States
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Silver Spring, Maryland, 20910, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02215, United States
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Ann Arbor, Michigan, 48197, United States
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Detroit, Michigan, 48201, United States
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Royal Oak, Michigan, 48073, United States
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Duluth, Minnesota, 55805, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Omaha, Nebraska, 68105, United States
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Las Vegas, Nevada, 89169, United States
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Lebanon, New Hampshire, 03756, United States
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Camden, New Jersey, 08103, United States
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Paramus, New Jersey, 07652, United States
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Albany, New York, 12206, United States
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East Syracuse, New York, 13057, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10016, United States
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Rochester, New York, 14642, United States
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Stony Brook, New York, 11794, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10467, United States
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Winston-Salem, North Carolina, 27157, United States
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Grand Forks, North Dakota, 58201, United States
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Akron, Ohio, 44304, United States
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Blue Ash, Ohio, 45242, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44106, United States
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Portland, Oregon, 97210, United States
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Portland, Oregon, 97213, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Charleston, South Carolina, 29425, United States
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Sioux Falls, South Dakota, 57105, United States
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Watertown, South Dakota, 57201, United States
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Austin, Texas, 78745, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77030, United States
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Sherman, Texas, 75090, United States
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Burlington, Vermont, 05401, United States
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Richmond, Virginia, 23249, United States
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Bellingham, Washington, 98225, United States
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Seattle, Washington, 98195, United States
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Spokane Valley, Washington, 99216, United States
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Milwaukee, Wisconsin, 53226, United States
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Clayton, 3168, Australia
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Aalst, 9300, Belgium
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Charleroi, 6060, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Barretos, 14784-400, Brazil
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Porto Alegre, 90110-270, Brazil
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Recife, 52010-075, Brazil
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Rio de Janeiro, 22271-110, Brazil
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São Paulo, 01327-001, Brazil
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Volta Redonda, 27258-000, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Beijing, 100021, China
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Beijing, 100142, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610042, China
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Fuzhou, 350005, China
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Hangzhou, 310002, China
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Hangzhou, 310022, China
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Hefei, 230031, China
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Jinan, 250117, China
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Nanjing, 210009, China
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Shanghai, 200002, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Shenyang, 100003, China
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Suzhou, 215006, China
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Wenzhou, 325000, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Zhengzhou, 450008, China
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Bron, 69677, France
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Dijon, 21079, France
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Lyon, 69317, France
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Nantes, 44202, France
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Pierre-Bénite, 69310, France
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Toulouse, 31000, France
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Villejuif, 94805, France
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Dresden, 01307, Germany
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Göttingen, 37075, Germany
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Halle, 06120, Germany
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Hanover, 30459, Germany
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Heidelberg, 69126, Germany
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Homburg, 66424, Germany
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Regensburg, 93053, Germany
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Trier, 54292, Germany
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Athens, 11526, Greece
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Athens, 11527, Greece
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Thessaloniki, 55236, Greece
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 95847, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Florence, 50134, Italy
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Genova, 16132, Italy
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Milan, 20132, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Pavia, 27100, Italy
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Roma, 00128, Italy
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Rozzano, 20089, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8677, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Hirosaki-shi, 036-8563, Japan
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Hiroshima, 734-8551, Japan
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Kobe, 650-0047, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 060-8648, Japan
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Sunto-gun, 411-8777, Japan
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Toyoake-shi, 470-1192, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1081 HV, Netherlands
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Groningen, 9713 GZ, Netherlands
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Utrecht, 3584 CX, Netherlands
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Bydgoszcz, 85-796, Poland
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Elblag, 02-300, Poland
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Gdansk, 80-952, Poland
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Katowice, 40-514, Poland
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Lodz, 93-513, Poland
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Warsaw, 02-781, Poland
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Hato Rey, 00917, Puerto Rico
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Kazan, Tatarstan, 420029, Russia
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Moscow, 105229, Russia
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Moscow, 115478, Russia
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Moscow, 119421, Russia
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Saint Petersburg, 197758, Russia
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Ufa, 450054, Russia
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Yekaterinburg, 620905, Russia
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Cheongju-si, 28644, South Korea
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Goyang-si, 10408, South Korea
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Gyeonggi-do, 13620, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Badajoz, 6006, Spain
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Barcelona, 08041, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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San Sebastián, 20014, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Zaragoza, 50009, Spain
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Istanbul, 34214, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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Kocaeli, 41400, Turkey (Türkiye)
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Birmingham, B9 5SS, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, EC1A 7BE, United Kingdom
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Manchester, M20 4BX, United Kingdom

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