AzTrials
AzTrials

Carcinoma，Non-Small-Cell LungPhase 3NCT03088540

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing Pemetrexed, Paclitaxel and Gemcitabine in people with Carcinoma，Non-Small-Cell Lung and Lung Carcinomas, Non-Small-Cell, run by Regeneron Pharmaceuticals at 192 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objectives of the study are: To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells To compare the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pemetrexed, Paclitaxel and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
712 participants
Where
192 sitesin 24 countries
Study dates
29 May 2017to 18 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient must meet the following criteria to be eligible for inclusion in the study:
  • 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
  • Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
  • Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
  • At least 1 radiographically measureable lesion per RECIST 1.1
  • ECOG performance status of ≤1
  • Anticipated life expectancy of at least 3 months
  • Adequate organ and bone marrow function

Who cannot join

  • A patient who meets any of the following criteria will be excluded from the study:
  • Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
  • Active or untreated brain metastases or spinal cord compression
  • Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
  • Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
  • 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
Show all 21Show fewer
  • Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
  • Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
  • Another malignancy that is progressing or requires treatment
  • Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
  • Active infection requiring systemic therapy within 14 days prior to randomization
  • Prior therapy with anti-PD 1 or anti-PD L1
  • Treatment-related immune-mediated AEs from immune-modulatory agents
  • Receipt of an investigational drug or device within 30 days
  • Receipt of a live vaccine within 30 days of planned start of study medication
  • Major surgery or significant traumatic injury within 4 weeks prior to first dose
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
  • Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
  • Pregnant or breastfeeding women
  • 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.

Trial locations and contacts

192 sites in 24 countries.

192 sites in 24 countries

Russia25 sites

  • Clinical Study Site

    Arkhangelsk

  • Clinical Study Site

    Belgorod

  • Clinical Study Site

    Chelyabinsk

  • Clinical Study Site

    Kaluga

  • Clinical Study Site

    Kazan'

  • Clinical Study Site

    Kemerovo

  • Clinical Study Site

    Kislino

  • Clinical Study Site

    Kursk

  • Clinical Study Site 1

    Moscow

  • Clinical Study Site 2

    Moscow

  • Clinical Study Site 3

    Moscow

  • Clinical Study Site

    Omsk

  • Clinical Study Site

    Pushkin, Sankt-Peterburg

  • Clinical Study Site

    Pyatigorsk

  • Clinical Study Site 1

    Saint Petersburg

  • Clinical Study Site 2

    Saint Petersburg

  • Clinical Study Site 3

    Saint Petersburg

  • Clinical Study Site 4

    Saint Petersburg

  • Clinical Study Site

    Samara

  • Clinical Study Site

    Saransk

  • Clinical Study Site

    Sochi

  • Clinical Study Site 1

    Tomsk

  • Clinical Study Site 2

    Tomsk

  • Clinical Study Site

    Ufa, Republic Bashkortost

  • Clinical Study Site

    Yekaterinburg

Other trials in Russia

Brazil19 sites

  • Clinical Study Site

    Barretos

  • Clinical Study Site

    Curitiba

  • Clinical Study Site

    Joinville

  • Clinical Study Site

    Lajeado

  • Clinical Study Site

    Mogi das Cruzes

  • Clinical Study Site

    Passo Fundo

  • Clinical Study Site

    Pelotas

  • Clinical Study Site 1

    Porto Alegre, Rio Grande do Sul

  • Clinical Study Site 2

    Porto Alegre

  • Clinical Study Site 3

    Porto Alegre

  • Clinical Study Site

    Recife

  • Clinical Study Site

    Rio de Janeiro

  • Clinical Study Site

    Salvador

  • Clinical Study Site

    Santa Cecília

  • Clinical Study Site

    São José do Rio Preto

  • Clinical Study Site #3

    São Paulo

  • Clinical Study Site #4

    São Paulo

  • Clinical Study Site 1

    São Paulo

  • Clinical Study Site 2

    São Paulo

Other trials in Brazil

Turkey (Türkiye)16 sites

  • Clinical Study Site 1

    Adana

  • Clinical Study Site 2

    Adana

  • Clinical Study Site 1

    Ankara

  • Clinical Study Site 2

    Ankara

  • Clinical Study Site 3

    Ankara

  • Clinical Study Site 4

    Ankara

  • Clinical Study Site 5

    Ankara

  • Clinical Study Site

    Edirne

  • Clinical Study Site 1

    Istanbul

  • Clinical Study Site 2

    Istanbul

  • Clinical Study Site 3

    Istanbul

  • Clinical Study Site 4

    Istanbul

  • Clinical Study Site 1

    Izmir

  • Clinical Study Site 2

    Izmir

  • Clinical Study Site 3

    Izmir

  • Clinical Study Site

    Samsun

Other trials in Turkey (Türkiye)

Poland12 sites

  • Clinical Study Site

    Dąbrowa Górnicza

  • Clinical Study Site

    Gdynia

  • Clinical Study Site

    Krakow

  • Clinical Study Site

    Lodz

  • Clinical Study Site

    Olsztyn

  • Clinical Study Site

    Poznan

  • Clinical Study Site

    Prabuty

  • Clinical Study Site

    Radom

  • Clinical Study Site

    Rzeszów

  • Clinical Study Site

    Torun

  • Clinical Study Site

    Warsaw

  • Clinical Study Site

    Wodzisław Śląski

Other trials in Poland

Ukraine12 sites

  • Clinical Study Site

    Dnipro

  • Clinical Study Site

    Ivano-Frankivsk

  • Clinical Study Site

    Kharkiv

  • Clinical Study Site

    Kherson

  • Clinical Study Site 1

    Kiev

  • Clinical Study Site 2

    Kiev

  • Clinical Study Site

    Kirovohrad

  • Clinical Study Site 1

    Kyiv

  • Clinical Study Site 2

    Kyiv

  • Clinical Study Site

    Uzhhorod

  • Clinical Study Site

    Vinnytsia

  • Clinical Study Site

    Zaporizhzhya

Other trials in Ukraine

Taiwan11 sites

  • Clinical Study Site

    Chang-hua

  • Clinical Study Site

    Hualien City

  • Clinical Study Site 1

    Kaohsiung City

  • Clinical Study Site 2

    Kaohsiung City

  • Clinical Study Site 1

    New Taipei City

  • Clinical Study Site 2

    New Taipei City

  • Clinical Study Site 1

    Taichung

  • Clinical Study Site 2

    Taichung

  • Clinical Study Site 1

    Taipei

  • Clinical Study Site 2

    Taipei

  • Clinical Study Site 3

    Taipei

Other trials in Taiwan

China10 sites

  • Clinical Study Site

    Guangdong

  • Clinical Study Site

    Harbin

  • Clinical Study Site

    Lanshan, Shandong

  • Clinical Study Site

    Linyi

  • Clinical Study Site 1

    Shanghai

  • Clinical Study Site 2

    Shanghai

  • Clinical Study Site 1

    Tianjin

  • Clinical Study Site 2

    Tianjin

  • Clinical Study Site

    Xuzhou

  • Clinical Study Site

    Zhejiang

Other trials in China

Greece10 sites

  • Clinical Study Site 1

    Athens

  • Clinical Study Site 2

    Athens

  • Clinical Study Site 3

    Athens

  • Clinical Study Site

    Cholargós, Attica

  • Clinical Study Site

    Larissa

  • Clinical Study Site

    Pátrai, Achaia

  • Clinical Study Site

    Pylaia

  • Clinical Study Site 1

    Thessaloniki

  • Clinical Study Site 2

    Thessaloniki

  • Clinical Study Site 3

    Thessaloniki

Other trials in Greece

Thailand10 sites

  • Clinical Study Site #1

    Bangkok

  • Clinical Study Site #2

    Bangkok

  • Clinical Study Site

    Chiang Rai

  • Clinical Study Site

    Hat Yai, Changwat Songkhla

  • Clinical Study Site

    Khon Kaen

  • Clinical Study Site

    Lampang

  • Clinical Study Site

    Lopburi, Muang

  • Clinical Study Site

    Phitsanulok

  • Clinical Study Site

    Ratchathewi

  • Clinical Study Site

    Udon Thani

Other trials in Thailand

Mexico9 sites

  • Clinical Study Site

    Coahuila

  • Clinical Study Site

    Cuautitlán

  • Clinical Study Site

    Jalisco

  • Clinical Study Site

    León

  • Clinical Study Site 1

    Monterrey

  • Clinical Study Site 2

    Monterrey

  • Clinical Study Site 3

    Monterrey

  • Clinical Study Site

    Oaxaca City

  • Clinical Study Site

    San Luis Potosí City

Other trials in Mexico

Philippines9 sites

  • Clinical Study Site

    Bacolod City

  • Clinical Study Site

    Batangas

  • Clinical Study Site

    Cebu

  • Clinical Study Site

    City of Taguig

  • Clinical Study Site

    Davao City

  • Clinical Study Site 1

    Manila

  • Clinical Study Site 2

    Manila

  • Clinical Study Site #1

    Quezon City

  • Clinical Study Site #2

    Quezon City

Other trials in Philippines

Georgia7 sites

  • Clinical Study Site

    Batumi

  • Clinical Study Site #6

    Tbilisi

  • Clinical Study Site 1

    Tbilisi

  • Clinical Study Site 2

    Tbilisi

  • Clinical Study Site 3

    Tbilisi

  • Clinical Study Site 4

    Tbilisi

  • Clinical Study Site 5

    Tbilisi

Other trials in Georgia

Hungary6 sites

  • Clinical Study Site

    Budapest

  • Clinical Study Site

    Debrecen

  • Clinical Study Site

    Farkasgyepű, Veszprém megye

  • Clinical Study Site

    Gyula, Bekes County

  • Clinical Study Site

    Tatabánya, Komárom-Esztergom

  • Clinical Study Site

    Zalaegerszeg

Other trials in Hungary

Malaysia6 sites

  • Clinical Study Site

    Kampung Baharu Nilai

  • Clinical Study Site #1

    Kuala Lumpur

  • Clinical Study Site #2

    Kuala Lumpur

  • Clinical Study Site

    Kuching

  • Clinical Study Site

    Pulau Pinang

  • Clinical Study Site

    Tanjong Bungah

Other trials in Malaysia

Romania5 sites

  • Clinical Study Site 1

    Craiova

  • Clinical Study Site 2

    Craiova

  • Clinical Study Site

    Floreşti

  • Clinical Study Site

    Ploieşti

  • Clinical Study Site

    Timișoara

Other trials in Romania

Chile4 sites

  • Clinical Study Site

    Recoleta

  • Clinical Study Site

    Santiago

  • Clinical Study Site

    Temuco

  • Clincial Study Site

    Viña del Mar

Other trials in Chile

Australia3 sites

  • Clinical Study Site

    Albury, New South Wales

  • Clinical Study Site

    Fitzroy

  • Clinical Study Site

    Wollongong, New South Wales

Other trials in Australia

Colombia3 sites

  • Clinical Study Site

    Barranquilla

  • Clinical Study Site

    Bogotá

  • Clinical Study Site

    Floridablanca

Other trials in Colombia

Czechia3 sites

  • Clinical Study Site

    Nový Jičín

  • Clinical Study Site

    Pelhřimov

  • Clinical Study Site

    Prague

Other trials in Czechia

Lebanon3 sites

  • Clinical Study Site

    Bsalîm

  • Clinical Study Site

    Mazraat ech Choûf

  • Clinical Study Site

    Sidon

Other trials in Lebanon

Spain3 sites

  • Clinical Study Site

    Barcelona

  • Clinical Study Site

    Manresa, Barcelona

  • Clinical Study Site

    Pamplona

Other trials in Spain

Belarus2 sites

  • Clinical Study Site

    Minsk

  • Clinical Study Site

    Mogilev

Other trials in Belarus

Bulgaria2 sites

  • Clinical Study Site

    Dobrich

  • Clinical Study Site

    Gabrovo

Other trials in Bulgaria

Jordan2 sites

  • Clinical Study Site

    Amman

  • Clinical Study Site

    Irbid

Other trials in Jordan

About this study

Official title: A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

The primary objectives of the study are:

  • To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
  • To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells

The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

Read the detailed description

There is option to join genomics sub-study.

Keywords
Previous Smoker, Current Smoker, Stage IIIB, Stage IIIC, Stage IV, PD-L1
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PemetrexedDrug

    Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

  • PaclitaxelDrug

    Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

  • GemcitabineDrug

    Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

  • CisplatinDrug

    Administered with either Pemetrexed, Paclitaxel or gemcitabine.

  • CarboplatinDrug

    Administered with either Pemetrexed, Paclitaxel or gemcitabine.

  • cemiplimabDrug

    Also called REGN2810, Libtayo

    Patients will be administered cemiplimab as per protocol.

Study groups in NCT03088540
Study groupRoleWhat they receive
Standard-of-care chemotherapyActive comparatorStandard-of-care chemotherapy will administered from these options: Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance
Receives: Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin
cemiplimabExperimentalcemiplimab regimen as monotherapy as per study protocol
Receives: Drug: cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as the time from randomization to the date of death due to any cause.

    Measured: Up to 94 months

  2. Progression-free Survival (PFS) Per Blinded IRC

    PFS as assessed by blinded IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.

    Measured: Up to 94 months

Secondary outcomes (13)

  1. Objective Response Rate (ORR) Per IRC

    ORR was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by IRC per RECIST 1.1.

    Measured: Up to 73.5 months

  2. Best Overall Response (BOR) Per IRC

    BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.

    Measured: Up to 73.5 months

  3. Duration of Response (DoR) Per IRC

    DoR was defined as the time from date of first documented response of CR or PR to the date of first documented PD (per RECIST 1.1) or death due to any cause, whichever occurred earlier.

    Measured: Up to 73.5 months

  4. Change From Baseline in Global Health Status/Quality of Life (QoL) Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (physical, role, cognitive, emotional, social), 9 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a score ranging from 0 to 100; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.

    Measured: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39

  5. Change From Baseline in Coughing Scores as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)

    EORTC QLQ-LC13 is a 13-item questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia). Reported here are the EORTC lung cancer coughing scores only. Scores were calculated and transformed to a range from 0 to 100, with a higher score representing a higher level of symptoms/problems and a negative change from baseline value indicating reduction (i.e. improvement) in symptoms.

    Measured: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to 94 months

  7. Number of Participants With Serious TEAEs

    Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.

    Measured: Up to 94 months

  8. Number of Deaths During the On-Treatment Period

    The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.

    Measured: Up to approximately 28 months

  9. Number of Participants With Laboratory Abnormalities

    Reported here is the number of participants with at least one laboratory abnormality of any grade in measurements for hematology, electrolytes, liver function, chemistry, and coagulation.

    Measured: Up to approximately 28 months

  10. Trough Concentration (Ctrough) of Cemiplimab in Serum

    Measured: Up to 73.5 months

  11. Maximum Plasma Concentration (Cmax) of Cemiplimab in Serum

    Measured: Up to 73.5 months

  12. Number of Participants With Anti-Cemiplimab Antibodies (ADA)

    The ADA status of each participant was classified as one of the following:

    • Pre-existing - If the baseline sample is positive and all post baseline ADA titers are reported as less than 9-fold the baseline titer value
    • Negative - If all samples are found to be negative in the ADA assay
    • Treatment-emergent response

    Measured: Up to 73.5 months

  13. Number of Participants With Neutralizing Antibodies (NAb)

    The NAb status of each participant was categorized as follows:

    • Negative - Samples that tested negative in the ADA assay, or samples positive in the ADA assay but tested negative in the NAb assay
    • Positive

    Measured: Up to 73.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2017
  2. Study start29 May 2017
  3. Primary completion18 Apr 2025
  4. Study completion18 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088540
Sponsor's protocol ID
R2810-ONC-1624
Other IDs
2016-004407-31, 2024-515052-20-00, 2016
Status last verified
May 2026
First submitted
3 Mar 2017
Last updated
25 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Gandara DR, Gumus M, Kilickap S, Sezer A, Bondarenko I, Ozguroglu M, Gogishvili M, Yan E, Jia X, Kim E, Seebach F, Quek RGW. Review of patient-reported outcomes in EMPOWER-Lung 1 in patients with advanced non-small cell lung cancer treated with cemiplimab versus chemotherapy. Cancer. 2026 Mar 15;132(6):e70339. doi: 10.1002/cncr.70339.

    PubMed 41808570

  • Perez J, Kerr KM, Baker B, Fang F, Li J, McDonald J, Li S, Gao B, Pouliot JF, Seebach F, Lowy I, Gullo G, Herman G, Hamilton J, Rietschel P, McGuire K. Clinical Interchangeability of PD-L1 Immunohistochemistry Assays in First-Line Non-Small Cell Lung Cancer Management With Cemiplimab. JCO Precis Oncol. 2025 Sep;9:e2500177. doi: 10.1200/PO-25-00177. Epub 2025 Sep 24.

    PubMed 40991883

  • Kilickap S, Baramidze A, Sezer A, Ozguroglu M, Gumus M, Bondarenko I, Gogishvili M, Nechaeva M, Schenker M, Cicin I, Fuang HG, Kulyaba Y, Zyuhal K, Scheusan RI, Garassino MC, Li Y, Zhu C, Kaul M, Perez J, Seebach F, Lowy I, Pouliot JF, Kim E, Magnan H. Cemiplimab Monotherapy for First-Line Treatment of Patients with Advanced NSCLC With PD-L1 Expression of 50% or Higher: Five-Year Outcomes of EMPOWER-Lung 1. J Thorac Oncol. 2025 Jul;20(7):941-954. doi: 10.1016/j.jtho.2025.03.033. Epub 2025 Mar 19.

    PubMed 40118215

  • Ozguroglu M, Kilickap S, Sezer A, Gumus M, Bondarenko I, Gogishvili M, Nechaeva M, Schenker M, Cicin I, Ho GF, Kulyaba Y, Zyuhal K, Scheusan RI, Garassino MC, He X, Kaul M, Okoye E, Li Y, Li S, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P. First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Sep;24(9):989-1001. doi: 10.1016/S1470-2045(23)00329-7. Epub 2023 Aug 14.

    PubMed 37591293

  • Gumus M, Chen CI, Ivanescu C, Kilickap S, Bondarenko I, Ozguroglu M, Gogishvili M, Turk HM, Cicin I, Harnett J, Mastey V, Naumann U, Reaney M, Konidaris G, Sasane M, Brady KJS, Li S, Gullo G, Rietschel P, Sezer A. Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of >/=50%: The EMPOWER-Lung 1 study. Cancer. 2023 Jan 1;129(1):118-129. doi: 10.1002/cncr.34477. Epub 2022 Oct 29.

    PubMed 36308296

  • Sezer A, Kilickap S, Gumus M, Bondarenko I, Ozguroglu M, Gogishvili M, Turk HM, Cicin I, Bentsion D, Gladkov O, Clingan P, Sriuranpong V, Rizvi N, Gao B, Li S, Lee S, McGuire K, Chen CI, Makharadze T, Paydas S, Nechaeva M, Seebach F, Weinreich DM, Yancopoulos GD, Gullo G, Lowy I, Rietschel P. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021 Feb 13;397(10274):592-604. doi: 10.1016/S0140-6736(21)00228-2.

    PubMed 33581821

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed, Paclitaxel and Gemcitabine in people with Carcinoma，Non-Small-Cell Lung and Lung Carcinomas, Non-Small-Cell, run by Regeneron Pharmaceuticals at 192 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in Russia, Brazil, Turkey (Türkiye), Poland, Ukraine and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 94 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03088540, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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