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New immunotherapy shows promise against lung cancer in major trial

NCT ID NCT03088540

Disease control Sponsor: Regeneron Pharmaceuticals 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested the immunotherapy drug cemiplimab against standard platinum-based chemotherapy in 712 patients with advanced or metastatic non-small cell lung cancer that has high PD-L1 levels. The study aimed to see if cemiplimab improves overall survival and delays cancer progression. Patients received either cemiplimab or a chemotherapy combination. The results could offer a new first-line treatment option for this type of lung cancer.

What this could mean

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

Active substance
cemiplimab (an immunotherapy drug that helps the immune system fight cancer)
What this could lead to
If successful, this could provide a new first-line treatment option for people with advanced lung cancer that expresses PD-L1, potentially improving survival compared to standard chemotherapy.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all lung cancer patients. Immunotherapy can cause immune-related side effects, and not all patients respond.

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

712 people

The number who actually took part.

Started

May 2017

Finished

Apr 2025

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 years and older

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.

Key Inclusion Criteria: A patient must meet the following criteria to be eligible for inclusion in the study: 1. Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC 2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated 3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory 4. At least 1 radiographically measureable lesion per RECIST 1.1 5. ECOG performance status of ≤1 6. Anticipated life expectancy of at least 3 months 7. Adequate organ and bone marrow function Key Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: 1. Patients that have never smoked, defined as smoking \<100 cigarettes in a lifetime 2. Active or untreated brain metastases or spinal cord compression 3. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization 6. Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years 7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization 8. Another malignancy that is progressing or requires treatment 9. Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency 10. Active infection requiring systemic therapy within 14 days prior to randomization 11. Prior therapy with anti-PD 1 or anti-PD L1 12. Treatment-related immune-mediated AEs from immune-modulatory agents 13. Receipt of an investigational drug or device within 30 days 14. Receipt of a live vaccine within 30 days of planned start of study medication 15. Major surgery or significant traumatic injury within 4 weeks prior to first dose 16. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments 17. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs 18. Pregnant or breastfeeding women 19. Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose Note: Other protocol defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

lung cancer 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 Lung carcinomas, non-small-cell Non-small cell lung carcinoma Nonsmall cell lung cancer

Contacts and locations

Locations

  • Clincial Study Site

    Viña del Mar, Chile

  • Clinical Study Site

    Albury, New South Wales, Australia

  • Clinical Study Site

    Wollongong, New South Wales, Australia

  • Clinical Study Site

    Fitzroy, Australia

  • Clinical Study Site

    Minsk, Belarus

  • Clinical Study Site

    Mogilev, Belarus

  • Clinical Study Site

    Barretos, Brazil

  • Clinical Study Site

    Curitiba, Brazil

  • Clinical Study Site

    Joinville, Brazil

  • Clinical Study Site

    Lajeado, Brazil

  • Clinical Study Site

    Mogi das Cruzes, Brazil

  • Clinical Study Site

    Passo Fundo, Brazil

  • Clinical Study Site

    Pelotas, Brazil

  • Clinical Study Site

    Recife, Brazil

  • Clinical Study Site

    Rio de Janeiro, Brazil

  • Clinical Study Site

    Salvador, Brazil

  • Clinical Study Site

    Santa Cecília, Brazil

  • Clinical Study Site

    São José do Rio Preto, Brazil

  • Clinical Study Site

    Dobrich, Bulgaria

  • Clinical Study Site

    Gabrovo, Bulgaria

  • Clinical Study Site

    Recoleta, Chile

  • Clinical Study Site

    Santiago, Chile

  • Clinical Study Site

    Temuco, Chile

  • Clinical Study Site

    Lanshan, Shandong, China

  • Clinical Study Site

    Guangdong, China

  • Clinical Study Site

    Harbin, China

  • Clinical Study Site

    Linyi, China

  • Clinical Study Site

    Xuzhou, China

  • Clinical Study Site

    Zhejiang, China

  • Clinical Study Site

    Barranquilla, Colombia

  • Clinical Study Site

    Bogotá, Colombia

  • Clinical Study Site

    Floridablanca, Colombia

  • Clinical Study Site

    Nový Jičín, Czechia

  • Clinical Study Site

    Pelhřimov, Czechia

  • Clinical Study Site

    Prague, Czechia

  • Clinical Study Site

    Batumi, Georgia

  • Clinical Study Site

    Pátrai, Achaia, Greece

  • Clinical Study Site

    Cholargós, Attica, Greece

  • Clinical Study Site

    Larissa, Greece

  • Clinical Study Site

    Pylaia, Greece

  • Clinical Study Site

    Gyula, Bekes County, Hungary

  • Clinical Study Site

    Tatabánya, Komárom-Esztergom, Hungary

  • Clinical Study Site

    Farkasgyepű, Veszprém megye, Hungary

  • Clinical Study Site

    Budapest, Hungary

  • Clinical Study Site

    Debrecen, Hungary

  • Clinical Study Site

    Zalaegerszeg, Hungary

  • Clinical Study Site

    Amman, Jordan

  • Clinical Study Site

    Irbid, Jordan

  • Clinical Study Site

    Bsalîm, Lebanon

  • Clinical Study Site

    Mazraat ech Choûf, Lebanon

  • Clinical Study Site

    Sidon, Lebanon

  • Clinical Study Site

    Kampung Baharu Nilai, Malaysia

  • Clinical Study Site

    Kuching, Malaysia

  • Clinical Study Site

    Pulau Pinang, Malaysia

  • Clinical Study Site

    Tanjong Bungah, Malaysia

  • Clinical Study Site

    Coahuila, Mexico

  • Clinical Study Site

    Cuautitlán, Mexico

  • Clinical Study Site

    Jalisco, Mexico

  • Clinical Study Site

    León, Mexico

  • Clinical Study Site

    Oaxaca City, Mexico

  • Clinical Study Site

    San Luis Potosí City, Mexico

  • Clinical Study Site

    Bacolod City, Philippines

  • Clinical Study Site

    Batangas, Philippines

  • Clinical Study Site

    Cebu, Philippines

  • Clinical Study Site

    City of Taguig, Philippines

  • Clinical Study Site

    Davao City, Philippines

  • Clinical Study Site

    Dąbrowa Górnicza, Poland

  • Clinical Study Site

    Gdynia, Poland

  • Clinical Study Site

    Krakow, Poland

  • Clinical Study Site

    Lodz, Poland

  • Clinical Study Site

    Olsztyn, Poland

  • Clinical Study Site

    Poznan, Poland

  • Clinical Study Site

    Prabuty, Poland

  • Clinical Study Site

    Radom, Poland

  • Clinical Study Site

    Rzeszów, Poland

  • Clinical Study Site

    Torun, Poland

  • Clinical Study Site

    Warsaw, Poland

  • Clinical Study Site

    Wodzisław Śląski, Poland

  • Clinical Study Site

    Floreşti, Romania

  • Clinical Study Site

    Ploieşti, Romania

  • Clinical Study Site

    Timișoara, Romania

  • Clinical Study Site

    Ufa, Republic Bashkortost, Russia

  • Clinical Study Site

    Pushkin, Sankt-Peterburg, Russia

  • Clinical Study Site

    Arkhangelsk, Russia

  • Clinical Study Site

    Belgorod, Russia

  • Clinical Study Site

    Chelyabinsk, Russia

  • Clinical Study Site

    Kaluga, Russia

  • Clinical Study Site

    Kazan', Russia

  • Clinical Study Site

    Kemerovo, Russia

  • Clinical Study Site

    Kislino, Russia

  • Clinical Study Site

    Kursk, Russia

  • Clinical Study Site

    Omsk, Russia

  • Clinical Study Site

    Pyatigorsk, Russia

  • Clinical Study Site

    Samara, Russia

  • Clinical Study Site

    Saransk, Russia

  • Clinical Study Site

    Sochi, Russia

  • Clinical Study Site

    Yekaterinburg, Russia

  • Clinical Study Site

    Manresa, Barcelona, Spain

  • Clinical Study Site

    Barcelona, Spain

  • Clinical Study Site

    Pamplona, Spain

  • Clinical Study Site

    Chang-hua, Taiwan

  • Clinical Study Site

    Hualien City, Taiwan

  • Clinical Study Site

    Hat Yai, Changwat Songkhla, Thailand

  • Clinical Study Site

    Lopburi, Muang, Thailand

  • Clinical Study Site

    Chiang Rai, Thailand

  • Clinical Study Site

    Khon Kaen, Thailand

  • Clinical Study Site

    Lampang, Thailand

  • Clinical Study Site

    Phitsanulok, Thailand

  • Clinical Study Site

    Ratchathewi, Thailand

  • Clinical Study Site

    Udon Thani, Thailand

  • Clinical Study Site

    Edirne, Turkey (Türkiye)

  • Clinical Study Site

    Samsun, Turkey (Türkiye)

  • Clinical Study Site

    Dnipro, Ukraine

  • Clinical Study Site

    Ivano-Frankivsk, Ukraine

  • Clinical Study Site

    Kharkiv, Ukraine

  • Clinical Study Site

    Kherson, Ukraine

  • Clinical Study Site

    Kirovohrad, Ukraine

  • Clinical Study Site

    Uzhhorod, Ukraine

  • Clinical Study Site

    Vinnytsia, Ukraine

  • Clinical Study Site

    Zaporizhzhya, Ukraine

  • Clinical Study Site #1

    Kuala Lumpur, Malaysia

  • Clinical Study Site #1

    Quezon City, Philippines

  • Clinical Study Site #1

    Bangkok, Thailand

  • Clinical Study Site #2

    Kuala Lumpur, Malaysia

  • Clinical Study Site #2

    Quezon City, Philippines

  • Clinical Study Site #2

    Bangkok, Thailand

  • Clinical Study Site #3

    São Paulo, Brazil

  • Clinical Study Site #4

    São Paulo, Brazil

  • Clinical Study Site #6

    Tbilisi, Georgia

  • Clinical Study Site 1

    Porto Alegre, Rio Grande do Sul, Brazil

  • Clinical Study Site 1

    São Paulo, Brazil

  • Clinical Study Site 1

    Shanghai, China

  • Clinical Study Site 1

    Tianjin, China

  • Clinical Study Site 1

    Tbilisi, Georgia

  • Clinical Study Site 1

    Athens, Greece

  • Clinical Study Site 1

    Thessaloniki, Greece

  • Clinical Study Site 1

    Monterrey, Mexico

  • Clinical Study Site 1

    Manila, Philippines

  • Clinical Study Site 1

    Craiova, Romania

  • Clinical Study Site 1

    Moscow, Russia

  • Clinical Study Site 1

    Saint Petersburg, Russia

  • Clinical Study Site 1

    Tomsk, Russia

  • Clinical Study Site 1

    Kaohsiung City, Taiwan

  • Clinical Study Site 1

    New Taipei City, Taiwan

  • Clinical Study Site 1

    Taichung, Taiwan

  • Clinical Study Site 1

    Taipei, Taiwan

  • Clinical Study Site 1

    Adana, Turkey (Türkiye)

  • Clinical Study Site 1

    Ankara, Turkey (Türkiye)

  • Clinical Study Site 1

    Istanbul, Turkey (Türkiye)

  • Clinical Study Site 1

    Izmir, Turkey (Türkiye)

  • Clinical Study Site 1

    Kiev, Ukraine

  • Clinical Study Site 1

    Kyiv, Ukraine

  • Clinical Study Site 2

    Porto Alegre, Brazil

  • Clinical Study Site 2

    São Paulo, Brazil

  • Clinical Study Site 2

    Shanghai, China

  • Clinical Study Site 2

    Tianjin, China

  • Clinical Study Site 2

    Tbilisi, Georgia

  • Clinical Study Site 2

    Athens, Greece

  • Clinical Study Site 2

    Thessaloniki, Greece

  • Clinical Study Site 2

    Monterrey, Mexico

  • Clinical Study Site 2

    Manila, Philippines

  • Clinical Study Site 2

    Craiova, Romania

  • Clinical Study Site 2

    Moscow, Russia

  • Clinical Study Site 2

    Saint Petersburg, Russia

  • Clinical Study Site 2

    Tomsk, Russia

  • Clinical Study Site 2

    Kaohsiung City, Taiwan

  • Clinical Study Site 2

    New Taipei City, Taiwan

  • Clinical Study Site 2

    Taichung, Taiwan

  • Clinical Study Site 2

    Taipei, Taiwan

  • Clinical Study Site 2

    Adana, Turkey (Türkiye)

  • Clinical Study Site 2

    Ankara, Turkey (Türkiye)

  • Clinical Study Site 2

    Istanbul, Turkey (Türkiye)

  • Clinical Study Site 2

    Izmir, Turkey (Türkiye)

  • Clinical Study Site 2

    Kiev, Ukraine

  • Clinical Study Site 2

    Kyiv, Ukraine

  • Clinical Study Site 3

    Porto Alegre, Brazil

  • Clinical Study Site 3

    Tbilisi, Georgia

  • Clinical Study Site 3

    Athens, Greece

  • Clinical Study Site 3

    Thessaloniki, Greece

  • Clinical Study Site 3

    Monterrey, Mexico

  • Clinical Study Site 3

    Moscow, Russia

  • Clinical Study Site 3

    Saint Petersburg, Russia

  • Clinical Study Site 3

    Taipei, Taiwan

  • Clinical Study Site 3

    Ankara, Turkey (Türkiye)

  • Clinical Study Site 3

    Istanbul, Turkey (Türkiye)

  • Clinical Study Site 3

    Izmir, Turkey (Türkiye)

  • Clinical Study Site 4

    Tbilisi, Georgia

  • Clinical Study Site 4

    Saint Petersburg, Russia

  • Clinical Study Site 4

    Ankara, Turkey (Türkiye)

  • Clinical Study Site 4

    Istanbul, Turkey (Türkiye)

  • Clinical Study Site 5

    Tbilisi, Georgia

  • Clinical Study Site 5

    Ankara, Turkey (Türkiye)

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