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NCT03409614 · CITED IN SOURCE DOCUMENTS

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

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
2026-05-18

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.

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

Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)

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outcome · POSTED

Part 2: PFS Per IRC

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outcome · POSTED

Part 1: Objective Response Rate (ORR) Per IRC

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outcome · POSTED

Part 2: ORR Per IRC

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outcome · POSTED

Part 1: Duration of Response (DoR)

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outcome · POSTED

Part 2: DoR

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outcome · POSTED

Part 1: Best Overall Response (BOR) Per IRC

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outcome · POSTED

Part 2: BOR Per IRC

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outcome · POSTED

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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outcome · POSTED

Part 2: Number of Participants With TEAEs

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outcome · POSTED

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

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outcome · POSTED

Part 1: Number of Participants With Serious TEAEs

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outcome · POSTED

Part 2: Number of Participants With Serious TEAEs

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outcome · POSTED

Part 1: Number of Deaths During the On-Treatment Period

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outcome · POSTED

Part 2: Number of Deaths During the On-Treatment Period

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outcome · POSTED

Part 1: Estimated Survival Probability

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outcome · POSTED

Part 2: Estimated Survival Probability

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outcome · POSTED

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)

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outcome · POSTED

Part 1: Overall Survival (OS)

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outcome · POSTED

Part 2: OS

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outcome · POSTED

Part 2: Change From Baseline in Global Health Status Score as Measured by the EORTC QLQ-C30

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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: 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Part 1: Chemotherapy
    intervention Names
    1. Other: Chemotherapy
    2. Drug: Placebo
    label
    Chemo
    type
    OTHER
  2. description
    Part 1: REGN2810+chemo
    intervention Names
    1. Drug: REGN2810
    label
    REGN2810+Chemo Part 1
    type
    EXPERIMENTAL
  3. description
    Part 1: REGN2810+abbrev chemo+ipi
    intervention Names
    1. Drug: REGN2810/chemo/ipi
    label
    REGN2810+AbbrevChemo+ipi
    type
    EXPERIMENTAL
  4. description
    Part 2: Placebo plus chemo
    intervention Names
    1. Drug: Placebo
    label
    Placebo+Chemo
    type
    EXPERIMENTAL
  5. description
    Part 2: REGN2810+chemo
    intervention Names
    1. Drug: REGN2810
    label
    REGN2810+Chemo Part 2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. REGN2810+Chemo Part 1
    2. REGN2810+Chemo Part 2
    description
    REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
    name
    REGN2810
    other Names
    1. cemiplimab
    type
    DRUG
  2. arm Group Labels
    1. REGN2810+AbbrevChemo+ipi
    description
    REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
    name
    REGN2810/chemo/ipi
    other Names
    1. cemiplimab
    type
    DRUG
  3. arm Group Labels
    1. Chemo
    description
    Platinum-based doublet chemotherapy Part 1
    name
    Chemotherapy
    type
    OTHER
  4. arm Group Labels
    1. Chemo
    2. Placebo+Chemo
    description
    Matching placebo Part 2
    name
    Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
masking Description
Part 1: Open label Part 2: Double blind
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
789
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
    Part 1: Overall Survival (OS)
    time Frame
    Up to a maximum of 82.2 months
  2. description
    OS was defined as the time from randomization to the date of death due to any cause.
    measure
    Part 2: OS
    time Frame
    Up to a maximum of 68.4 months
secondary Outcomes
  1. description
    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.
    measure
    Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)
    time Frame
    Up to a maximum of 82.2 months
  2. description
    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.
    measure
    Part 2: PFS Per IRC
    time Frame
    Up to a maximum of 68.4 months
  3. description
    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).
    measure
    Part 1: Objective Response Rate (ORR) Per IRC
    time Frame
    Up to 32 months
  4. description
    ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a BOR of confirmed CR or PR.
    measure
    Part 2: ORR Per IRC
    time Frame
    Up to 32 months
  5. description
    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.
    measure
    Part 1: Duration of Response (DoR)
    time Frame
    Up to 32 months
  6. description
    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.
    measure
    Part 2: DoR
    time Frame
    Up to 32 months
  7. 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
    Part 1: Best Overall Response (BOR) Per IRC
    time Frame
    Up to 32 months
  8. 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
    Part 2: BOR Per IRC
    time Frame
    Up to 32 months
  9. 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.
    measure
    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
  10. 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.
    measure
    Part 2: Number of Participants With TEAEs
    time Frame
    From first dose of study drug in Part 2, up to approximately 69 months
  11. description
    Part 1 only
    measure
    Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
    time Frame
    28 days
  12. 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
    Part 1: Number of Participants With Serious TEAEs
    time Frame
    From first dose of study drug in Part 1, up to approximately 83 months
Full study description
brief 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 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.
Source references
references
  1. citation
    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.
    pmid
    38820979
    type
    DERIVED
  2. citation
    Zhao 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.
    pmid
    37348996
    type
    DERIVED
  3. citation
    Makharadze 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.
    pmid
    37001859
    type
    DERIVED
  4. citation
    Gogishvili 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.
    pmid
    36008722
    type
    DERIVED
see Also Links
  1. label
    A Plain Language Summary is available on TrialSummaries.com
Source notices and limitations
    Discovery and provenance
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        s chemotherapy):</p> <div class="pdq-content-list"><ol id="_485961"><li>A phase III, double-blind, placebo-controlled trial (<a href="/clinicaltrials/NCT03409614">EMPOWER-Lung 3</a> [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients ha
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      2. context exact
        iv class="pdq-content-list"><ol id="_485961"><li>A phase III, double-blind, placebo-controlled trial (<a href="/clinicaltrials/NCT03409614">EMPOWER-Lung 3</a> [NCT03409614]) examined cemiplimab-rwlc plus platinum-doublet chemotherapy in 466 patients with stage III or IV advanced NSCLC. Patients had not received previous chemother
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      source update dates
      1. context
        Updated: May 15, 2025
        datetime
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        May 15, 2025

    Preserved source evidence · Not medical advice