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New drug cocktail shows promise in slowing advanced lung cancer

NCT ID NCT03164616

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the immunotherapy drugs durvalumab (with or without tremelimumab) to standard chemotherapy helps people with advanced non-small cell lung cancer live longer or keep their cancer from growing. About 1,186 adults with metastatic NSCLC who had not received prior treatment took part. The goal was to see if the combination improves survival and disease control compared to chemotherapy alone.

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

1,186 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Nov 2027

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: For inclusion in the study, patients should fulfill the following criteria: 1. Aged at least 18 years. 2. Histologically or cytologically documented Stage IV NSCLC. 3. Confirmed tumor PD-L1 status prior to randomization. 4. Patients must have tumors that lack activating EGFR mutations and ALK fusions. 5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC. 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant. 2. Active or prior documented autoimmune or inflammatory disorders. 3. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids. 4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • Research Site

    Phoenix, Arizona, 85054, United States

  • Research Site

    Bakersfield, California, 93309, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Fort Myers, Florida, 33901, United States

  • Research Site

    Jacksonville, Florida, 32224, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    West Palm Beach, Florida, 33401, United States

  • Research Site

    Louisville, Kentucky, 40202, United States

  • Research Site

    Kansas City, Missouri, 64132, United States

  • Research Site

    Canton, Ohio, 44710, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Fort Worth, Texas, 76104, United States

  • Research Site

    Houston, Texas, 77090, United States

  • Research Site

    Richmond, Virginia, 23298, United States

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Belo Horizonte, 30380-472, Brazil

  • Research Site

    Curitiba, 81520-060, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Porto Alegre, 90610-000, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Ribeirão Preto, 14015-140, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    Santo André, 09060-650, Brazil

  • Research Site

    Santo André, 09080-110, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01209-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, 03102-002, Brazil

  • Research Site

    Plovdiv, 4000, Bulgaria

  • Research Site

    Plovdiv, 4004, Bulgaria

  • Research Site

    Sofia, 1330, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Sofia, 1618, Bulgaria

  • Research Site

    Sofia, 1784, Bulgaria

  • Research Site

    Varna, 9010, Bulgaria

  • Research Site

    Beijing, 100021, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Changchun, 130012, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Fuzhou, 350014, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Harbin, 150081, China

  • Research Site

    Hefei, 230601, China

  • Research Site

    Kunming, CN-650034, China

  • Research Site

    Linyi, 276000, China

  • Research Site

    Liuzhou, 545006, China

  • Research Site

    Nanjing, 210009, China

  • Research Site

    Qingdao, 110016, China

  • Research Site

    Shanghai, 200030, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shanghai, 200080, China

  • Research Site

    Shantou, 515041, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Wuhan, 430079, China

  • Research Site

    Xining, 810001, China

  • Research Site

    Yangzhou, 225001, China

  • Research Site

    Zhanjiang, 524001, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Zhengzhou, 450052, China

  • Research Site

    Berlin, 13125, Germany

  • Research Site

    Essen, 45122, Germany

  • Research Site

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    Gauting, 82131, Germany

  • Research Site

    Hamburg, 20251, Germany

  • Research Site

    Hamburg, 21075, Germany

  • Research Site

    Heidelberg, 69126, Germany

  • Research Site

    Immenhausen, 34376, Germany

  • Research Site

    Mainz, 55131, Germany

  • Research Site

    Oldenburg, 26121, Germany

  • Research Site

    Würzburg, 97067, Germany

  • Research Site

    Shatin, 00000, Hong Kong

  • Research Site

    Budapest, 1083, Hungary

  • Research Site

    Budapest, 1121, Hungary

  • Research Site

    Kecskemét, 6000, Hungary

  • Research Site

    Miskolc, 3529, Hungary

  • Research Site

    Törökbálint, 2045, Hungary

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hiroshima, 730-0011, Japan

  • Research Site

    Iwakuni-shi, 740-8510, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kurume-shi, 830-0011, Japan

  • Research Site

    Matsuyama, 790-0007, Japan

  • Research Site

    Okayama, 700-8558, Japan

  • Research Site

    Okayama, 700-8607, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Sayama, 589-8511, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Toyoake-shi, 470-1101, Japan

  • Research Site

    Ube-shi, 755-0241, Japan

  • Research Site

    Yokohama, 236-0004, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Aguascalientes, 20230, Mexico

  • Research Site

    Cuautitlán Izcalli, 54769, Mexico

  • Research Site

    Guadalajara, 44280, Mexico

  • Research Site

    Mexico City, 0 3100, Mexico

  • Research Site

    México, 04739, Mexico

  • Research Site

    México, 14080, Mexico

  • Research Site

    Monterrey, 64060, Mexico

  • Research Site

    Monterrey, 64460, Mexico

  • Research Site

    Tuxtla Gutiérrez, 29030, Mexico

  • Research Site

    Arequipa, AREQUIPA01, Peru

  • Research Site

    Lima, L27, Peru

  • Research Site

    Lima, LIMA 29, Peru

  • Research Site

    Lima, LIMA 34, Peru

  • Research Site

    Lima, LIMA 41, Peru

  • Research Site

    San Isidro, 27, Peru

  • Research Site

    Olsztyn, 10-357, Poland

  • Research Site

    Tomaszów Mazowiecki, 97-200, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Wodzisław Śląski, 44-300, Poland

  • Research Site

    Moscow, 105229, Russia

  • Research Site

    Moscow, 115280, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 125367, Russia

  • Research Site

    Omsk, 644013, Russia

  • Research Site

    Saint Petersburg, 194291, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 196603, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Cape Town, 7570, South Africa

  • Research Site

    Durban, 4091, South Africa

  • Research Site

    Johannesburg, 0001, South Africa

  • Research Site

    Parktown, 2193, South Africa

  • Research Site

    Pretoria, 0001, South Africa

  • Research Site

    Rondebosch, 7700, South Africa

  • Research Site

    Vereeniging, 1930, South Africa

  • Research Site

    Busan, 47392, South Korea

  • Research Site

    Chungcheongbuk-do, 28644, South Korea

  • Research Site

    Daegu, 42415, South Korea

  • Research Site

    Incheon, 21565, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 120-752, South Korea

  • Research Site

    Seoul, 6351, South Korea

  • Research Site

    Ulsan, 44033, South Korea

  • Research Site

    Changhua, 50006, Taiwan

  • Research Site

    Kaohsiung City, 82445, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 112, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10210, Thailand

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Muang, 50200, Thailand

  • Research Site

    Songkhla, 90110, Thailand

  • Research Site

    Dnipro, 49102, Ukraine

  • Research Site

    Ivano-Frankivsk, 76018, Ukraine

  • Research Site

    Kirovohrad, 25006, Ukraine

  • Research Site

    Kyiv, 03022, Ukraine

  • Research Site

    Kyiv, 03115, Ukraine

  • Research Site

    Lviv, 79031, Ukraine

  • Research Site

    Odesa, 65055, Ukraine

  • Research Site

    Sumy, 40022, Ukraine

  • Research Site

    Vinnytsia, 21029, Ukraine

  • Research Site

    Zaporizhzhia, 69040, Ukraine

  • Research Site

    Leicester, LE1 5WW, United Kingdom

  • Research Site

    London, EC1M 6BQ, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    London, W6 8RF, United Kingdom

  • Research Site

    Manchester, M20 4BX, United Kingdom

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

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