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Immunotherapy plus chemotherapy shows promise in advanced lung cancer trial

NCT ID NCT03409614

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested whether adding the immunotherapy drug cemiplimab to standard chemotherapy helps people with advanced non-small cell lung cancer live longer. The trial enrolled 789 participants and compared different drug combinations. The main goal was to see if the combination improved overall survival compared to chemotherapy alone.

What this could mean

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

Active substance
cemiplimab (immunotherapy drug) plus platinum-based chemotherapy
What this could lead to
If successful, this combination could become a standard first-line treatment for advanced lung cancer, helping patients live longer.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all lung cancer types. Immunotherapy can cause immune-related side effects.

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

789 people

The number who actually took part.

Started

Mar 2018

Finished

Feb 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: 1. Men and women ≥20 years of age for Japanese patients 2. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC 3. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated 4. Part 1 only: Expression of PD-L1 in \<50% of tumor cells determined by a commercially available assay performed by the central laboratory 5. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 7. Anticipated life expectancy of at least 3 months Key Exclusion Criteria: 1. Part 1 only: Patients who 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 Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment 5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years 6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs) 7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply

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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

Contacts and locations

Locations

  • Regeneron Research Site

    Le Mans, 72000, France

  • Regeneron Research Site

    Lille, 59037, France

  • Regeneron Research Site

    Lyon, 69310, France

  • Regeneron Research Site

    Mont-de-Marsan, 40024, France

  • Regeneron Research Site

    Saint-Herblain, 44805, France

  • Regeneron Research Site

    Saint-Mandé, 94160, France

  • Regeneron Research Site

    Strasbourg, 67091, France

  • Regeneron Research Site

    Batumi, 6000, Georgia

  • Regeneron Research Site

    Tbilisi, 0112, Georgia

  • Regeneron Research Site

    Tbilisi, 0144, Georgia

  • Regeneron Research Site

    Tbilisi, 0186, Georgia

  • Regeneron Research Site

    Thessaloniki, Macedonia, 54645, Greece

  • Regeneron Research Site

    Athens, 11527, Greece

  • Regeneron Research Site

    Kifissia, 14564, Greece

  • Regeneron Research Site

    Larissa, 41334, Greece

  • Regeneron Research Site

    Pylaia, 57001, Greece

  • Regeneron Research Site

    Thessaloniki, 54007, Greece

  • Regeneron Research Site

    Dublin, 9, Ireland

  • Regeneron Research Site

    Limerick, V94F858, Ireland

  • Regeneron Research Site

    Cremona, 26100, Italy

  • Regeneron Research Site

    Meldola, 47014, Italy

  • Regeneron Research Site

    Milan, 20162, Italy

  • Regeneron Research Site

    Monserrato, 09042, Italy

  • Regeneron Research Site

    Piacenza, 29121, Italy

  • Regeneron Research Site

    Saronno, 21047, Italy

  • Regeneron Research Site

    Terni, 05100, Italy

  • Regeneron Research Site

    Treviglio, 24047, Italy

  • Regeneron Research Site

    Klaipėda, LT-92288, Lithuania

  • Regeneron Research Site

    Zhengzhou, 450003, China

  • Regeneron Research Site

    Zhengzhou, 450008, China

  • Regeneron Research Site

    Bayonne, 64100, France

  • Regeneron Research Site

    Créteil, 94010, France

  • Regeneron Research Site

    Rancho Mirage, California, 92270, United States

  • Regeneron Research Site

    Riverside, California, 92506, United States

  • Regeneron Research Site

    Whittier, California, 90603, United States

  • Regeneron Research Site

    Orange City, Florida, 32763, United States

  • Regeneron Research Site

    St. Petersburg, Florida, 33709, United States

  • Regeneron Research Site

    Wichita, Kansas, 67214, United States

  • Regeneron Research Site

    Bethesda, Maryland, 20817, United States

  • Regeneron Research Site

    Farmington, New Mexico, 87401, United States

  • Regeneron Research Site

    Gettysburg, Pennsylvania, 17325, United States

  • Regeneron Research Site

    Vienna, 1130, Austria

  • Regeneron Research Site

    Baoding, 071105, China

  • Regeneron Research Site

    Changsha, 410013, China

  • Regeneron Research Site

    Guangzhou, 510080, China

  • Regeneron Research Site

    Hangzhou, 310002, China

  • Regeneron Research Site

    Hangzhou, 310003, China

  • Regeneron Research Site

    Hangzhou, 310009, China

  • Regeneron Research Site

    Hangzhou, 310013, China

  • Regeneron Research Site

    Jinan, 250013, China

  • Regeneron Research Site

    Linyi, 276001, China

  • Regeneron Research Site

    Nanjing, 210003, China

  • Regeneron Research Site

    Shanghai, 200040, China

  • Regeneron Research Site

    Shanghai, 200433, China

  • Regeneron Research Site

    Shenyang, 110042, China

  • Regeneron Research Site

    Xiangyang, 441021, China

  • Regeneron Research Site

    Vilnius, LT-08660, Lithuania

  • Regeneron Research Site

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • Regeneron Research Site

    George Town, 10350, Malaysia

  • Regeneron Research Site

    Johor Bahru, 81100, Malaysia

  • Regeneron Research Site

    Kota Kinabalu, 88996, Malaysia

  • Regeneron Research Site

    Kuala Lumpur, 56000, Malaysia

  • Regeneron Research Site

    Kuala Lumpur, 59100, Malaysia

  • Regeneron Research Site

    Kuantan, 25100, Malaysia

  • Regeneron Research Site

    Pulau Pinang, 10990, Malaysia

  • Regeneron Research Site

    Tanjung Bungah, 11200, Malaysia

  • Regeneron Research Site

    Gdynia, Pomeranian Voivodeship, 81-519, Poland

  • Regeneron Research Site

    Lodz, 90-302, Poland

  • Regeneron Research Site

    Lublin, 20-093, Poland

  • Regeneron Research Site

    Olsztyn, 10-357, Poland

  • Regeneron Research Site

    Otwock, 05-400, Poland

  • Regeneron Research Site

    Poznan, 60-693, Poland

  • Regeneron Research Site

    Rzeszów, 35-021, Poland

  • Regeneron Research Site

    Torun, 87-100, Poland

  • Regeneron Research Site

    Wodzisław Śląski, 44-300, Poland

  • Regeneron Research Site

    Cluj-Napoca, 400006, Romania

  • Regeneron Research Site

    Cluj-Napoca, 400124, Romania

  • Regeneron Research Site

    Craiova, 200094, Romania

  • Regeneron Research Site

    Craiova, 200347, Romania

  • Regeneron Research Site

    Craiova, 200385, Romania

  • Regeneron Research Site

    Ufa, Republic Bashkortost, 450054, Russia

  • Regeneron Research Site

    Arkhangelsk, 163045, Russia

  • Regeneron Research Site

    Belgorod, 308010, Russia

  • Regeneron Research Site

    Chelyabinsk, 454048, Russia

  • Regeneron Research Site

    Kaluga, 248007, Russia

  • Regeneron Research Site

    Kazan', 420029, Russia

  • Regeneron Research Site

    Kursk, 305016, Russia

  • Regeneron Research Site

    Moscow, 115478, Russia

  • Regeneron Research Site

    Moscow, 121467, Russia

  • Regeneron Research Site

    Moscow Region, 143444, Russia

  • Regeneron Research Site

    Omsk, 644013, Russia

  • Regeneron Research Site

    Pushkin, 196603, Russia

  • Regeneron Research Site

    Pyatigorsk, 357502, Russia

  • Regeneron Research Site

    Saint Petersburg, 191104, Russia

  • Regeneron Research Site

    Saint Petersburg, 197758, Russia

  • Regeneron Research Site

    Saint Petersburg, 198255, Russia

  • Regeneron Research Site

    Samara, 443001, Russia

  • Regeneron Research Site

    Saransk, 430032, Russia

  • Regeneron Research Site

    Sochi, 354057, Russia

  • Regeneron Research Site

    Tomsk, 634028, Russia

  • Regeneron Research Site

    Tomsk, 634050, Russia

  • Regeneron Research Site

    Yekaterinburg, 620036, Russia

  • Regeneron Research Site

    Banka, 92101, Slovakia

  • Regeneron Research Site

    Cheongju-si, 28644, South Korea

  • Regeneron Research Site

    Incheon, 21565, South Korea

  • Regeneron Research Site

    Jeonju, 54907, South Korea

  • Regeneron Research Site

    Seongnam-si, 13496, South Korea

  • Regeneron Research Site

    Seongnam-si, 13620, South Korea

  • Regeneron Research Site

    Seoul, 05368, South Korea

  • Regeneron Research Site

    Seoul, 05505, South Korea

  • Regeneron Research Site

    Seoul, 06351, South Korea

  • Regeneron Research Site

    Suwon, 16499, South Korea

  • Regeneron Research Site

    Muang, Changwat Chiang Rai, 57000, Thailand

  • Regeneron Research Site

    A. Mueang, Changwat Lampang, 52000, Thailand

  • Regeneron Research Site

    Muang, Changwat Phitsanulok, 65000, Thailand

  • Regeneron Research Site

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Regeneron Research Site

    Udon Thani, Udonthani, 41330, Thailand

  • Regeneron Research Site

    Muang, 15000, Thailand

  • Regeneron Research Site

    Adana, 01120, Turkey (Türkiye)

  • Regeneron Research Site

    Ankara, 06100, Turkey (Türkiye)

  • Regeneron Research Site

    Istanbul, 34000, Turkey (Türkiye)

  • Regeneron Research Site

    Istanbul, 34093, Turkey (Türkiye)

  • Regeneron Research Site

    Dnipro, 49102, Ukraine

  • Regeneron Research Site

    Kharkiv, 61070, Ukraine

  • Regeneron Research Site

    Kiev, 03022, Ukraine

  • Regeneron Research Site

    Kirovohrad, 25006, Ukraine

  • Regeneron Research Site

    Uzhhorod, 88014, Ukraine

  • Regeneron Research Site

    Vinnytsia, 21029, Ukraine

  • Regeneron Research Site #1

    Tbilisi, 0159, Georgia

  • Regeneron Research Site #1

    Ratchathewi, 10400, Thailand

  • Regeneron Research Site #2

    Tbilisi, 0159, Georgia

  • Regeneron Research Site #2

    Ratchathewi, Bangkok, 10400, Thailand

  • Regeneron research Site

    Beijing, 100050, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.