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NCT03088540 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-06-25

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Progression-free Survival (PFS) Per Blinded IRC

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outcome · POSTED

Objective Response Rate (ORR) Per IRC

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outcome · POSTED

Best Overall Response (BOR) Per IRC

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outcome · POSTED

Duration of Response (DoR) Per IRC

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outcome · POSTED

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)

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outcome · POSTED

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)

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outcome · POSTED

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

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outcome · POSTED

Number of Participants With Serious TEAEs

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outcome · POSTED

Number of Deaths During the On-Treatment Period

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outcome · POSTED

Number of Participants With Laboratory Abnormalities

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outcome · POSTED

Trough Concentration (Ctrough) of Cemiplimab in Serum

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outcome · POSTED

Maximum Plasma Concentration (Cmax) of Cemiplimab in Serum

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outcome · POSTED

Number of Participants With Anti-Cemiplimab Antibodies (ADA)

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outcome · POSTED

Number of Participants With Neutralizing Antibodies (NAb)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Standard-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
    intervention Names
    1. Drug: Pemetrexed
    2. Drug: Paclitaxel
    3. Drug: Gemcitabine
    4. Drug: Cisplatin
    5. Drug: Carboplatin
    label
    Standard-of-care chemotherapy
    type
    ACTIVE_COMPARATOR
  2. description
    cemiplimab regimen as monotherapy as per study protocol
    intervention Names
    1. Drug: cemiplimab
    label
    cemiplimab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Standard-of-care chemotherapy
    description
    Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
    name
    Pemetrexed
    type
    DRUG
  2. arm Group Labels
    1. Standard-of-care chemotherapy
    description
    Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
    name
    Paclitaxel
    type
    DRUG
  3. arm Group Labels
    1. Standard-of-care chemotherapy
    description
    Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
    name
    Gemcitabine
    type
    DRUG
  4. arm Group Labels
    1. Standard-of-care chemotherapy
    description
    Administered with either Pemetrexed, Paclitaxel or gemcitabine.
    name
    Cisplatin
    type
    DRUG
  5. arm Group Labels
    1. Standard-of-care chemotherapy
    description
    Administered with either Pemetrexed, Paclitaxel or gemcitabine.
    name
    Carboplatin
    type
    DRUG
  6. arm Group Labels
    1. cemiplimab
    description
    Patients will be administered cemiplimab as per protocol.
    name
    cemiplimab
    other Names
    1. REGN2810
    2. Libtayo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
CROSSOVER
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
712
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    OS was defined as the time from randomization to the date of death due to any cause.
    measure
    Overall Survival (OS)
    time Frame
    Up to 94 months
  2. description
    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.
    measure
    Progression-free Survival (PFS) Per Blinded IRC
    time Frame
    Up to 94 months
secondary Outcomes
  1. description
    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.
    measure
    Objective Response Rate (ORR) Per IRC
    time Frame
    Up to 73.5 months
  2. description
    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.
    measure
    Best Overall Response (BOR) Per IRC
    time Frame
    Up to 73.5 months
  3. description
    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.
    measure
    Duration of Response (DoR) Per IRC
    time Frame
    Up to 73.5 months
  4. description
    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.
    measure
    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)
    time Frame
    Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39
  5. description
    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.
    measure
    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)
    time Frame
    Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39
  6. description
    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.
    measure
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    time Frame
    Up to 94 months
  7. description
    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.
    measure
    Number of Participants With Serious TEAEs
    time Frame
    Up to 94 months
  8. description
    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.
    measure
    Number of Deaths During the On-Treatment Period
    time Frame
    Up to approximately 28 months
  9. description
    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.
    measure
    Number of Participants With Laboratory Abnormalities
    time Frame
    Up to approximately 28 months
  10. measure
    Trough Concentration (Ctrough) of Cemiplimab in Serum
    time Frame
    Up to 73.5 months
  11. measure
    Maximum Plasma Concentration (Cmax) of Cemiplimab in Serum
    time Frame
    Up to 73.5 months
  12. description
    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
    measure
    Number of Participants With Anti-Cemiplimab Antibodies (ADA)
    time Frame
    Up to 73.5 months
Full study description
brief 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 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
detailed Description
There is option to join genomics sub-study.
Source references
references
  1. citation
    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.
    pmid
    41808570
    type
    DERIVED
  2. citation
    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.
    pmid
    40991883
    type
    DERIVED
  3. citation
    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.
    pmid
    40118215
    type
    DERIVED
  4. citation
    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.
    pmid
    37591293
    type
    DERIVED
  5. citation
    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.
    pmid
    36308296
    type
    DERIVED
  6. citation
    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.
    pmid
    33581821
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        ="-1">Evidence (cemiplimab-rwlc alone):</p> <div class="pdq-content-list"><ol id="_485966"><li>A phase III open-label study (<a href="/clinicaltrials/NCT03088540">EMPOWER-Lung 1</a> [NCT03088540]) enrolled 710 patients with advanced NSCLC and PD-L1 tumor expression of at least 50%. Patients were randomly assigned (1:1)
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        up', year: 2025, report: 'July 2025 issue', cutoff: 'January 16, 2024', followup: 'Median follow-up in the verified PD-L1 ≥50% population: 57.3 months.', nct: 'NCT03088540', doi: '10.1016/j.jtho.2025.03.033', population: 'Previously untreated advanced NSCLC, verified PD-L1 at least 50%, without EGFR, ALK, or ROS1 alterations. Som
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    Preserved source evidence · Not medical advice