Non-small Cell Lung CancerPhase 3NCT03409614
Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
A Phase 3 study testing REGN2810, REGN2810/chemo/ipi and Chemotherapy in people with Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 133 sites in 18 countries.
Trial summary
The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- REGN2810, REGN2810/chemo/ipi and Chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 789 participants
- Where
- 133 sitesin 18 countries
- Study dates
- 6 Mar 2018to 27 Feb 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
- Men and women ≥20 years of age for Japanese patients
- 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
- 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
- Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Anticipated life expectancy of at least 3 months
Who cannot join
- Part 1 only: Patients who 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 Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment
- 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
- 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)
- 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
Trial locations and contacts
133 sites in 18 countries.
133 sites in 18 countries
Russia22 sites
Regeneron Research Site
Arkhangelsk, 163045
Regeneron Research Site
Belgorod, 308010
Regeneron Research Site
Chelyabinsk, 454048
Regeneron Research Site
Kaluga, 248007
Regeneron Research Site
Kazan', 420029
Regeneron Research Site
Kursk, 305016
Regeneron Research Site
Moscow, 115478
Regeneron Research Site
Moscow, 121467
Regeneron Research Site
Moscow Region, 143444
Regeneron Research Site
Omsk, 644013
Regeneron Research Site
Pushkin, 196603
Regeneron Research Site
Pyatigorsk, 357502
Regeneron Research Site
Saint Petersburg, 191104
Regeneron Research Site
Saint Petersburg, 197758
Regeneron Research Site
Saint Petersburg, 198255
Regeneron Research Site
Samara, 443001
Regeneron Research Site
Saransk, 430032
Regeneron Research Site
Sochi, 354057
Regeneron Research Site
Tomsk, 634028
Regeneron Research Site
Tomsk, 634050
Regeneron Research Site
Ufa, Republic Bashkortost, 450054
Regeneron Research Site
Yekaterinburg, 620036
China17 sites
Regeneron Research Site
Baoding, 071105
Regeneron research Site
Beijing, 100050
Regeneron Research Site
Changsha, 410013
Regeneron Research Site
Guangzhou, 510080
Regeneron Research Site
Hangzhou, 310002
Regeneron Research Site
Hangzhou, 310003
Regeneron Research Site
Hangzhou, 310009
Regeneron Research Site
Hangzhou, 310013
Regeneron Research Site
Jinan, 250013
Regeneron Research Site
Linyi, 276001
Regeneron Research Site
Nanjing, 210003
Regeneron Research Site
Shanghai, 200040
Regeneron Research Site
Shanghai, 200433
Regeneron Research Site
Shenyang, 110042
Regeneron Research Site
Xiangyang, 441021
Regeneron Research Site
Zhengzhou, 450003
Regeneron Research Site
Zhengzhou, 450008
United States9 sites
Regeneron Research Site
Bethesda, Maryland, 20817
Regeneron Research Site
Farmington, New Mexico, 87401
Regeneron Research Site
Gettysburg, Pennsylvania, 17325
Regeneron Research Site
Orange City, Florida, 32763
Regeneron Research Site
Rancho Mirage, California, 92270
Regeneron Research Site
Riverside, California, 92506
Regeneron Research Site
St. Petersburg, Florida, 33709
Regeneron Research Site
Whittier, California, 90603
Regeneron Research Site
Wichita, Kansas, 67214
France9 sites
Regeneron Research Site
Bayonne, 64100
Regeneron Research Site
Créteil, 94010
Regeneron Research Site
Le Mans, 72000
Regeneron Research Site
Lille, 59037
Regeneron Research Site
Lyon, 69310
Regeneron Research Site
Mont-de-Marsan, 40024
Regeneron Research Site
Saint-Herblain, 44805
Regeneron Research Site
Saint-Mandé, 94160
Regeneron Research Site
Strasbourg, 67091
Malaysia9 sites
Regeneron Research Site
George Town, 10350
Regeneron Research Site
Johor Bahru, 81100
Regeneron Research Site
Kota Kinabalu, 88996
Regeneron Research Site
Kuala Lumpur, Kuala Lumpur, 59100
Regeneron Research Site
Kuala Lumpur, 56000
Regeneron Research Site
Kuala Lumpur, 59100
Regeneron Research Site
Kuantan, 25100
Regeneron Research Site
Pulau Pinang, 10990
Regeneron Research Site
Tanjung Bungah, 11200
Poland9 sites
Regeneron Research Site
Gdynia, Pomeranian Voivodeship, 81-519
Regeneron Research Site
Lodz, 90-302
Regeneron Research Site
Lublin, 20-093
Regeneron Research Site
Olsztyn, 10-357
Regeneron Research Site
Otwock, 05-400
Regeneron Research Site
Poznan, 60-693
Regeneron Research Site
Rzeszów, 35-021
Regeneron Research Site
Torun, 87-100
Regeneron Research Site
Wodzisław Śląski, 44-300
South Korea9 sites
Regeneron Research Site
Cheongju-si, 28644
Regeneron Research Site
Incheon, 21565
Regeneron Research Site
Jeonju, 54907
Regeneron Research Site
Seongnam-si, 13496
Regeneron Research Site
Seongnam-si, 13620
Regeneron Research Site
Seoul, 05368
Regeneron Research Site
Seoul, 05505
Regeneron Research Site
Seoul, 06351
Regeneron Research Site
Suwon, 16499
Italy8 sites
Regeneron Research Site
Cremona, 26100
Regeneron Research Site
Meldola, 47014
Regeneron Research Site
Milan, 20162
Regeneron Research Site
Monserrato, 09042
Regeneron Research Site
Piacenza, 29121
Regeneron Research Site
Saronno, 21047
Regeneron Research Site
Terni, 05100
Regeneron Research Site
Treviglio, 24047
Thailand8 sites
Regeneron Research Site
A. Mueang, Changwat Lampang, 52000
Regeneron Research Site
Hat Yai, Changwat Songkhla, 90110
Regeneron Research Site
Muang, Changwat Chiang Rai, 57000
Regeneron Research Site
Muang, Changwat Phitsanulok, 65000
Regeneron Research Site
Muang, 15000
Regeneron Research Site #2
Ratchathewi, Bangkok, 10400
Regeneron Research Site #1
Ratchathewi, 10400
Regeneron Research Site
Udon Thani, Udonthani, 41330
Georgia6 sites
Regeneron Research Site
Batumi, 6000
Regeneron Research Site
Tbilisi, 0112
Regeneron Research Site
Tbilisi, 0144
Regeneron Research Site #1
Tbilisi, 0159
Regeneron Research Site #2
Tbilisi, 0159
Regeneron Research Site
Tbilisi, 0186
Greece6 sites
Regeneron Research Site
Athens, 11527
Regeneron Research Site
Kifissia, 14564
Regeneron Research Site
Larissa, 41334
Regeneron Research Site
Pylaia, 57001
Regeneron Research Site
Thessaloniki, Macedonia, 54645
Regeneron Research Site
Thessaloniki, 54007
Ukraine6 sites
Regeneron Research Site
Dnipro, 49102
Regeneron Research Site
Kharkiv, 61070
Regeneron Research Site
Kiev, 03022
Regeneron Research Site
Kirovohrad, 25006
Regeneron Research Site
Uzhhorod, 88014
Regeneron Research Site
Vinnytsia, 21029
Romania5 sites
Regeneron Research Site
Cluj-Napoca, 400006
Regeneron Research Site
Cluj-Napoca, 400124
Regeneron Research Site
Craiova, 200094
Regeneron Research Site
Craiova, 200347
Regeneron Research Site
Craiova, 200385
Turkey (Türkiye)4 sites
Regeneron Research Site
Adana, 01120
Regeneron Research Site
Ankara, 06100
Regeneron Research Site
Istanbul, 34000
Regeneron Research Site
Istanbul, 34093
Ireland2 sites
Regeneron Research Site
Dublin, 9
Regeneron Research Site
Limerick, V94F858
Lithuania2 sites
Regeneron Research Site
Klaipėda, LT-92288
Regeneron Research Site
Vilnius, LT-08660
About this study
Official title: A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
The primary objectives of this study are:
Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.
Read more
Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
The key secondary objectives are:
Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells.
Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- REGN2810, REGN2810/chemo/ipi, Chemotherapy, Placebo
- Keywords
- Stage IIIB, Stage IIIC, Stage IV, Non-squamous NSCLC, Squamous NSCLC
- 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.
REGN2810Drug
Also called cemiplimab
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810/chemo/ipiDrug
Also called cemiplimab
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
ChemotherapyOther
Platinum-based doublet chemotherapy Part 1
PlaceboDrug
Matching placebo Part 2
| Study group | Role | What they receive |
|---|---|---|
| Chemo | Other | Part 1: Chemotherapy Receives: Other: Chemotherapy; Drug: Placebo |
| REGN2810+Chemo Part 1 | Experimental | Part 1: REGN2810+chemo Receives: Drug: REGN2810 |
| REGN2810+AbbrevChemo+ipi | Experimental | Part 1: REGN2810+abbrev chemo+ipi Receives: Drug: REGN2810/chemo/ipi |
| Placebo+Chemo | Experimental | Part 2: Placebo plus chemo Receives: Drug: Placebo |
| REGN2810+Chemo Part 2 | Experimental | Part 2: REGN2810+chemo Receives: Drug: REGN2810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Overall Survival (OS)
OS was defined as the time from randomization to the date of death due to any cause.
Measured: Up to a maximum of 82.2 months
Part 2: OS
OS was defined as the time from randomization to the date of death due to any cause.
Measured: Up to a maximum of 68.4 months
Secondary outcomes (19)
Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)
PFS as assessed by IRC per Response Evaluation Criteria in Solid Tumors version 1.1 (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 a maximum of 82.2 months
Part 2: PFS Per IRC
PFS as assessed by 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 a maximum of 68.4 months
Part 1: Objective Response Rate (ORR) Per IRC
ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).
Measured: Up to 32 months
Part 2: ORR Per IRC
ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a BOR of confirmed CR or PR.
Measured: Up to 32 months
Part 1: Duration of Response (DoR)
DoR was defined as the time from date of first documented response of CR or PR to the date of first documented progressive disease (PD) or death due to any cause, whichever occurred earlier.
Measured: Up to 32 months
Part 2: DoR
DoR was defined as the time from date of first documented response of CR or PR to the date of first documented PD or death due to any cause, whichever occurred earlier.
Measured: Up to 32 months
Part 1: 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 32 months
Part 2: 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 32 months
Part 1: 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.
Measured: From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With 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.
Measured: From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Part 1 only
Measured: 28 days
Part 1: 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: From first dose of study drug in Part 1, up to approximately 83 months
Part 2: 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: From first dose of study drug in Part 2, up to approximately 69 months
Part 1: 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 28 months
Part 2: 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 28 months
Part 1: Estimated Survival Probability
OS rate at a landmark (12, 18, and 24 months) was defined as the Kaplan-Meier (K-M) estimated probability of participants who survived due to any cause at the landmark after randomization.
Measured: 12 months, 18 months, 24 months
Part 2: Estimated Survival Probability
OS rate at a landmark (12, 18, and 24 months) was defined as the K-M estimated probability of participants who survived due to any cause at the landmark after randomization.
Measured: 12 months, 18 months, 24 months
Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization 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 quality of life (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 0-100 scale; 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, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months
Part 2: Change From Baseline in Global Health Status Score as Measured by the 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 0-100 scale; 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; Follow-up 1 (14 to 30 days after last study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start6 Mar 2018
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409614
- Sponsor's protocol ID
- R2810-ONC-16113
- Other IDs
- 2017-001311-36, 2017
- Status last verified
- May 2026
- First submitted
- 10 Jan 2018
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Baramidze A, Makharadze T, Gogishvili M, Melkadze T, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Ag McIntyre D, Perez J, Kaul M, Quek RGW, Seebach F, Rietschel P, Pouliot JF. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 >/= 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial. Lung Cancer. 2024 Jul;193:107821. doi: 10.1016/j.lungcan.2024.107821. Epub 2024 May 13.
PubMed 38820979Zhao B, Qi H, Wu J, Ma W. Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jul;18(7):e72-e73. doi: 10.1016/j.jtho.2023.04.001. No abstract available.
PubMed 37348996Makharadze T, Gogishvili M, Melkadze T, Baramidze A, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Li S, Li Y, Kaul M, Quek RGW, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P. Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jun;18(6):755-768. doi: 10.1016/j.jtho.2023.03.008. Epub 2023 Mar 29.
PubMed 37001859Gogishvili M, Melkadze T, Makharadze T, Giorgadze D, Dvorkin M, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Gessner C, Moreno-Jaime B, Passalacqua R, Li S, McGuire K, Kaul M, Paccaly A, Quek RGW, Gao B, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Gullo G, Rietschel P. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022 Nov;28(11):2374-2380. doi: 10.1038/s41591-022-01977-y. Epub 2022 Aug 25.
PubMed 36008722
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03409614
- Acronym / sponsor ID
- R2810-ONC-16113
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Stage IIIB, Stage IIIC, Stage IV, Non-squamous NSCLC, Squamous NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are:
Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.
Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
The key secondary objectives are:
Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells.
Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chemo | Other | Other: Chemotherapy, Drug: PlaceboPart 1: Chemotherapy |
| REGN2810+Chemo Part 1 | Experimental | Drug: REGN2810Part 1: REGN2810+chemo |
| REGN2810+AbbrevChemo+ipi | Experimental | Drug: REGN2810/chemo/ipiPart 1: REGN2810+abbrev chemo+ipi |
| Placebo+Chemo | Experimental | Drug: PlaceboPart 2: Placebo plus chemo |
| REGN2810+Chemo Part 2 | Experimental | Drug: REGN2810Part 2: REGN2810+chemo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥20 years of age for Japanese patients
- 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
- 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
- Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
- 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
Key exclusion criteria (8 listed)
- Part 1 only: Patients who 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 Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN2810Also: cemiplimabREGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2 | Drug | REGN2810+Chemo Part 1, REGN2810+Chemo Part 2 |
| REGN2810/chemo/ipiAlso: cemiplimabREGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1 | Drug | REGN2810+AbbrevChemo+ipi |
| ChemotherapyPlatinum-based doublet chemotherapy Part 1 | Other | Chemo |
| PlaceboMatching placebo Part 2 | Drug | Chemo, Placebo+Chemo |
Primary outcome
Part 1: Overall Survival (OS)
Time frame: Up to a maximum of 82.2 months
OS was defined as the time from randomization to the date of death due to any cause.
Part 2: OS
Time frame: Up to a maximum of 68.4 months
OS was defined as the time from randomization to the date of death due to any cause.
19 secondary outcomes
Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)
Time frame: Up to a maximum of 82.2 months
Part 2: PFS Per IRC
Time frame: Up to a maximum of 68.4 months
Part 1: Objective Response Rate (ORR) Per IRC
Time frame: Up to 32 months
Part 2: ORR Per IRC
Time frame: Up to 32 months
Part 1: Duration of Response (DoR)
Time frame: Up to 32 months
Part 2: DoR
Time frame: Up to 32 months
Part 1: Best Overall Response (BOR) Per IRC
Time frame: Up to 32 months
Part 2: BOR Per IRC
Time frame: Up to 32 months
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With TEAEs
Time frame: From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Part 1: Number of Participants With Serious TEAEs
Time frame: From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With Serious TEAEs
Time frame: From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Deaths During the On-Treatment Period
Time frame: Up to 28 months
Part 2: Number of Deaths During the On-Treatment Period
Time frame: Up to 28 months
Part 1: Estimated Survival Probability
Time frame: 12 months, 18 months, 24 months
Part 2: Estimated Survival Probability
Time frame: 12 months, 18 months, 24 months
Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months
Part 2: Change From Baseline in Global Health Status Score as Measured by the EORTC QLQ-C30
Time frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36; Follow-up 1 (14 to 30 days after last study treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38820979Baramidze A, Makharadze T, Gogishvili M, Melkadze T, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Ag McIntyre D, Perez J, Kaul M, Quek RGW, Seebach F, Rietschel P, Pouliot JF. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 >/= 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial. Lung Cancer. 2024 Jul;193:107821. doi: 10.1016/j.lungcan.2024.107821. Epub 2024 May 13.
- Derived from this study: PubMed 37348996Zhao B, Qi H, Wu J, Ma W. Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jul;18(7):e72-e73. doi: 10.1016/j.jtho.2023.04.001. No abstract available.
- Derived from this study: PubMed 37001859Makharadze T, Gogishvili M, Melkadze T, Baramidze A, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Li S, Li Y, Kaul M, Quek RGW, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P. Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jun;18(6):755-768. doi: 10.1016/j.jtho.2023.03.008. Epub 2023 Mar 29.
- Derived from this study: PubMed 36008722Gogishvili M, Melkadze T, Makharadze T, Giorgadze D, Dvorkin M, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Gessner C, Moreno-Jaime B, Passalacqua R, Li S, McGuire K, Kaul M, Paccaly A, Quek RGW, Gao B, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Gullo G, Rietschel P. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022 Nov;28(11):2374-2380. doi: 10.1038/s41591-022-01977-y. Epub 2022 Aug 25.
- A Plain Language Summary is available on TrialSummaries.comLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
133 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REGN2810, REGN2810/chemo/ipi and Chemotherapy in people with Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 133 sites in 18 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 7 inclusion and 8 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 133 sites in Russia, China, United States, France, Malaysia and 13 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 29 Apr 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?
Part 1: Overall Survival (OS) (time frame: Up to a maximum of 82.2 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 NCT03409614, which also lists 4 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 18 May 2026.