Immunotherapy combo aims to stop lung cancer return after chemoradiation

NCT ID NCT03703297

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether the immunotherapy drugs durvalumab (with or without tremelimumab) can help prevent cancer progression in people with limited-stage small cell lung cancer who have completed chemoradiation. About 730 participants will receive either the drug combination or a placebo. The study measures how long patients live without their cancer worsening and overall survival.

What this could mean

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

Active substance: durvalumab and tremelimumab (immunotherapy drugs given by IV)
What this could lead to: If successful, this could offer a new standard treatment to help prevent lung cancer from returning after initial chemoradiation.
What could go wrong: This is an advanced phase 3 trial, but immunotherapy can cause immune-related side effects. The combination may not improve survival over placebo, and 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

730 people

The number who actually took part.

Started

Sep 2018

Expected to finish

Oct 2026

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.

Inclusion criteria: 1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III). 2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules. 3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP. 4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment. Exclusion criteria: 1. Extensive-stage SCLC 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. 4. Active infection including tuberculosis, HIV, hepatitis B and C 5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

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Conditions

The condition(s) this trial relates to.

carcinoma lung neoplasm small cell lung carcinoma

As listed by the trial registrant

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

Small cell lung cancer

Contacts and locations

Locations

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Tucson, Arizona, 85715, United States
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Santa Rosa, California, 95403, United States
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New Haven, Connecticut, 06510, United States
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Fort Myers, Florida, 33901, United States
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Orange City, Florida, 32763, United States
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St. Petersburg, Florida, 33705, United States
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Marietta, Georgia, 30060, United States
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Hines, Illinois, 60141, United States
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Fort Wayne, Indiana, 46804, United States
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Muncie, Indiana, 47303, United States
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Lexington, Kentucky, 40536, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21287, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48201, United States
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Grand Rapids, Michigan, 49503, United States
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Minneapolis, Minnesota, 55407, United States
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Summit, New Jersey, 07902, United States
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New Hyde Park, New York, 11042, United States
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Chapel Hill, North Carolina, 27599, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Sioux Falls, South Dakota, 57104, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75390, United States
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Kennewick, Washington, 99336, United States
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Tacoma, Washington, 98405, United States
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Charleston, West Virginia, 25304, United States
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Huntington, West Virginia, 25701, United States
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Milwaukee, Wisconsin, 53226, United States
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CABA, C1012AAR, Argentina
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Ciudad de Buenos Aires, C1280AEB, Argentina
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Córdoba, X5004BAL, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, 2000, Argentina
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Aalst, 9300, Belgium
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Anderlecht, 1070, Belgium
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Brussels, 1200, Belgium
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Hasselt, 3500, Belgium
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Roeselare, 8800, Belgium
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Edmonton, Alberta, T6G 1Z2, Canada
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Toronto, CA, M5G 2M9, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 5W9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100021, China
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Beijing, 100036, China
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Beijing, 100142, China
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Beijing, 100191, China
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Beijing, 100730, China
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Bengbu, 233004, China
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Changchun, 130000, China
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Changsha, 410013, China
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Chengdu, 610042, China
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Chongqing, 400030, China
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Chongqing, 400042, China
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Fuzhou, 350011, China
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Hangzhou, 310003, China
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Hefei, 230601, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Tianjin, 300060, China
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Wuhan, 430010, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Yangzhou, 225001, China
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Zhengzhou, 450008, China
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Brno, 639 00, Czechia
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Olomouc, 77900, Czechia
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Ostrava, 703 00, Czechia
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Prague, 128 08, Czechia
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Prague, 140 59, Czechia
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Berlin, 12351, Germany
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Cologne, 51109, Germany
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Freiburg im Breisgau, 79106, Germany
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Gauting, 82131, Germany
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Heidelberg, 69126, Germany
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Mainz, 55131, Germany
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Münster, 48149, Germany
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Oldenburg, 26121, Germany
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Regensburg, 93053, Germany
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Stuttgart, 70376, Germany
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Würzburg, 97080, Germany
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Bengaluru, 560076, India
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Gurgaon, 122001, India
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Brescia, 25123, Italy
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Milan, 20133, Italy
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Milan, 20141, Italy
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Orbassano, 10043, Italy
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Parma, 43126, Italy
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Roma, 00100, Italy
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Rozzano, 20089, Italy
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Terni, 05100, Italy
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Bunkyō City, 160-0023, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 812-8582, Japan
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Iwakuni-shi, 740-8510, Japan
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Kashiwa, 277-8577, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Niigata, 951-8566, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 003-0804, Japan
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Sayama, 589-8511, Japan
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Sendai, 980-0873, Japan
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Sunto-gun, 411-8777, Japan
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Tokushima, 770-8503, Japan
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Ube-shi, 755-0241, Japan
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's-Hertogenbosch, 5223 GZ, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Groningen, 9713 GZ, Netherlands
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Harderwijk, 3844 DG, Netherlands
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Hengelo, 7555 DL, Netherlands
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Gdansk, 80-952, Poland
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Olsztyn, 10-357, Poland
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Poznan, 60-569, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Kazan', 420029, Russia
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Kirov, 610021, Russia
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Moscow, 105229, Russia
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Moscow, 115478, Russia
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Moscow, 125284, Russia
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Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Ufa, 450054, Russia
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Volgograd, 400138, Russia
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Changwon-si, 51353, South Korea
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Cheongju-si, 28644, South Korea
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Daegu, 42415, South Korea
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Goyang-si, 10408, South Korea
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Jinju, 52727, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Suwon, 16499, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08035, 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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Oviedo, 33011, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Hsinchu, 300, Taiwan
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Kaohsiung City, 83301, Taiwan
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Keelung, 20445, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 736, Taiwan
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Taipei, 112, Taiwan
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Taipei, 235, Taiwan
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Taoyuan City, 333, Taiwan
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Yunlin, 640, Taiwan
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Adana, 01060, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06280, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Izmir, 35620, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Manchester, M20 4BX, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam

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