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

October 20, 2023 updated by: Regeneron Pharmaceuticals

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

There is option to join genomics sub-study.

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia
        • Clinical Study Site
    • New South Wales
      • Albury, New South Wales, Australia
        • Clinical Study Site
      • Wollongong, New South Wales, Australia
        • Clinical Study Site
  • Belarus
      • Minsk, Belarus
        • Clinical Study Site
      • Mogilev, Belarus
        • Clinical Study Site
  • Brazil
      • Barretos, Brazil
        • Clinical Study Site
      • Curitiba, Brazil
        • Clinical Study Site
      • Joinville, Brazil
        • Clinical Study Site
      • Lajeado, Brazil
        • Clinical Study Site
      • Mogi Das Cruzes, Brazil
        • Clinical Study Site
      • Passo Fundo, Brazil
        • Clinical Study Site
      • Pelotas, Brazil
        • Clinical Study Site
      • Porto Alegre, Brazil
        • Clinical Study Site 2
      • Porto Alegre, Brazil
        • Clinical Study Site 3
      • Recife, Brazil
        • Clinical Study Site
      • Rio De Janeiro, Brazil
        • Clinical Study Site
      • Salvador, Brazil
        • Clinical Study Site
      • Santa Cecília, Brazil
        • Clinical Study Site
      • Sao Paulo, Brazil
        • Clinical Study Site #4
      • São José Do Rio Preto, Brazil
        • Clinical Study Site
      • São Paulo, Brazil
        • Clinical Study Site #3
      • São Paulo, Brazil
        • Clinical Study Site 1
      • São Paulo, Brazil
        • Clinical Study Site 2
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Clinical Study Site 1
  • Bulgaria
      • Dobrich, Bulgaria
        • Clinical Study Site
      • Gabrovo, Bulgaria
        • Clinical Study Site
  • Chile
      • Recoleta, Chile
        • Clinical Study Site
      • Santiago, Chile
        • Clinical Study Site
      • Temuco, Chile
        • Clinical Study Site
      • Viña Del Mar, Chile
        • Clincial Study Site
  • China
      • Guangdong, China
        • Clinical Study Site
      • Harbin, China
        • Clinical Study Site
      • Linyi, China
        • Clinical Study Site
      • Shanghai, China
        • Clinical Study Site 1
      • Shanghai, China
        • Clinical Study Site 2
      • Tianjin, China
        • Clinical Study Site 1
      • Tianjin, China
        • Clinical Study Site 2
      • Xuzhou, China
        • Clinical Study Site
      • Zhejiang, China
        • Clinical Study Site
    • Shandong
      • Lanshan, Shandong, China
        • Clinical Study Site
  • Colombia
      • Barranquilla, Colombia
        • Clinical Study Site
      • Bogotá, Colombia
        • Clinical Study Site
      • Floridablanca, Colombia
        • Clinical Study Site
  • Czechia
      • Nový Jičín, Czechia
        • Clinical Study Site
      • Pelhřimov, Czechia
        • Clinical Study Site
      • Prague, Czechia
        • Clinical Study Site
      • Praha, Czechia
        • Clinical Study Site
  • Georgia
      • Batumi, Georgia
        • Clinical Study Site
      • Tbilisi, Georgia
        • Clinical Study Site #6
      • Tbilisi, Georgia
        • Clinical Study Site 1
      • Tbilisi, Georgia
        • Clinical Study Site 2
      • Tbilisi, Georgia
        • Clinical Study Site 3
      • Tbilisi, Georgia
        • Clinical Study Site 4
      • Tbilisi, Georgia
        • Clinical Study Site 5
  • Greece
      • Athens, Greece
        • Clinical Study Site 1
      • Athens, Greece
        • Clinical Study Site 2
      • Athens, Greece
        • Clinical Study Site 3
      • Larissa, Greece
        • Clinical Study Site
      • Pylaía, Greece
        • Clinical Study Site
      • Thessaloníki, Greece
        • Clinical Study Site 1
      • Thessaloníki, Greece
        • Clinical Study Site 2
      • Thessaloníki, Greece
        • Clinical Study Site 3
    • Achaia
      • Patras, Achaia, Greece
        • Clinical Study Site
    • Attiki
      • Cholargós, Attiki, Greece
        • Clinical Study Site
  • Hungary
      • Budapest, Hungary
        • Clinical Study Site
      • Debrecen, Hungary
        • Clinical Study Site
      • Zalaegerszeg, Hungary
        • Clinical Study Site
    • Bekes
      • Gyula, Bekes, Hungary
        • Clinical Study Site
    • Komarom-Esztergom
      • Tatabánya, Komarom-Esztergom, Hungary
        • Clinical Study Site
    • Veszprém
      • Farkasgyepű, Veszprém, Hungary
        • Clinical Study Site
  • Jordan
      • Amman, Jordan
        • Clinical Study Site
      • Irbid, Jordan
        • Clinical Study Site
  • Lebanon
      • Bsalîm, Lebanon
        • Clinical Study Site
      • Mazraat Ech Choûf, Lebanon
        • Clinical Study Site
      • Sidon, Lebanon
        • Clinical Study Site
  • Malaysia
      • Kampung Baharu Nilai, Malaysia
        • Clinical Study Site
      • Kuala Lumpur, Malaysia
        • Clinical Study Site #1
      • Kuala Lumpur, Malaysia
        • Clinical Study Site #2
      • Kuching, Malaysia
        • Clinical Study Site
      • Pulau Pinang, Malaysia
        • Clinical Study Site
      • Tanjong Bungah, Malaysia
        • Clinical Study Site
  • Mexico
      • Coahuila, Mexico
        • Clinical Study Site
      • Cuautitlán, Mexico
        • Clinical Study Site
      • Jalisco, Mexico
        • Clinical Study Site
      • León de los Aldama, Mexico
        • Clinical Study Site
      • Monterrey, Mexico
        • Clinical Study Site 1
      • Monterrey, Mexico
        • Clinical Study Site 2
      • Monterrey, Mexico
        • Clinical Study Site 3
      • Oaxaca, Mexico
        • Clinical Study Site
      • San Luis Potosí, Mexico
        • Clinical Study Site
  • Philippines
      • Bacolod City, Philippines
        • Clinical Study Site
      • Batangas, Philippines
        • Clinical Study Site
      • Cebu, Philippines
        • Clinical Study Site
      • Davao City, Philippines
        • Clinical Study Site
      • Manila, Philippines
        • Clinical Study Site 1
      • Manila, Philippines
        • Clinical Study Site 2
      • Quezon City, Philippines
        • Clinical Study Site #1
      • Quezon City, Philippines
        • Clinical Study Site #2
      • Taguig, Philippines
        • Clinical Study Site
  • Poland
      • Dąbrowa Górnicza, Poland
        • Clinical Study Site
      • Gdynia, Poland
        • Clinical Study Site
      • Kraków, Poland
        • Clinical Study Site
      • Olsztyn, Poland
        • Clinical Study Site
      • Poznań, Poland
        • Clinical Study Site
      • Prabuty, Poland
        • Clinical Study Site
      • Radom, Poland
        • Clinical Study Site
      • Rzeszów, Poland
        • Clinical Study Site
      • Toruń, Poland
        • Clinical Study Site
      • Warszawa, Poland
        • Clinical Study Site
      • Wodzisław Śląski, Poland
        • Clinical Study Site
      • Łódź, Poland
        • Clinical Study Site
  • Romania
      • Craiova, Romania
        • Clinical Study Site 1
      • Craiova, Romania
        • Clinical Study Site 2
      • Floreşti, Romania
        • Clinical Study Site
      • Ploieşti, Romania
        • Clinical Study Site
      • Timişoara, Romania
        • Clinical Study Site
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Clinical Study Site
      • Belgorod, Russian Federation
        • Clinical Study Site
      • Chelyabinsk, Russian Federation
        • Clinical Study Site
      • Kaluga, Russian Federation
        • Clinical Study Site
      • Kazan, Russian Federation
        • Clinical Study Site
      • Kemerovo, Russian Federation
        • Clinical Study Site
      • Kislino, Russian Federation
        • Clinical Study Site
      • Kursk, Russian Federation
        • Clinical Study Site
      • Moscow, Russian Federation
        • Clinical Study Site 1
      • Moscow, Russian Federation
        • Clinical Study Site 2
      • Moscow, Russian Federation
        • Clinical Study Site 3
      • Omsk, Russian Federation
        • Clinical Study Site
      • Pyatigorsk, Russian Federation
        • Clinical Study Site
      • Saint Petersburg, Russian Federation
        • Clinical Study Site 1
      • Saint Petersburg, Russian Federation
        • Clinical Study Site 2
      • Saint Petersburg, Russian Federation
        • Clinical Study Site 3
      • Saint Petersburg, Russian Federation
        • Clinical Study Site 4
      • Samara, Russian Federation
        • Clinical Study Site
      • Saransk, Russian Federation
        • Clinical Study Site
      • Sochi, Russian Federation
        • Clinical Study Site
      • Tomsk, Russian Federation
        • Clinical Study Site 1
      • Tomsk, Russian Federation
        • Clinical Study Site 2
      • Yekaterinburg, Russian Federation
        • Clinical Study Site
    • Republic Bashkortost
      • Ufa, Republic Bashkortost, Russian Federation
        • Clinical Study Site
    • Saint Petersburg
      • Pushkin, Saint Petersburg, Russian Federation
        • Clinical Study Site
  • Spain
      • Barcelona, Spain
        • Clinical Study Site
      • Pamplona, Spain
        • Clinical Study Site
    • Barcelona
      • Manresa, Barcelona, Spain
        • Clinical Study Site
  • Taiwan
      • Chang Hua, Taiwan
        • Clinical Study Site
      • Hualien City, Taiwan
        • Clinical Study Site
      • Kaohsiung, Taiwan
        • Clinical Study Site 1
      • Kaohsiung, Taiwan
        • Clinical Study Site 2
      • New Taipei, Taiwan
        • Clinical Study Site 2
      • New Taipei City, Taiwan
        • Clinical Study Site 1
      • Taichung, Taiwan
        • Clinical Study Site 1
      • Taichung, Taiwan
        • Clinical Study Site 2
      • Taipei, Taiwan
        • Clinical Study Site 1
      • Taipei, Taiwan
        • Clinical Study Site 2
      • Taipei, Taiwan
        • Clinical Study Site 3
  • Thailand
      • Bangkok, Thailand
        • Clinical Study Site #1
      • Bangkok, Thailand
        • Clinical Study Site #2
      • Chiang Rai, Thailand
        • Clinical Study Site
      • Khon Kaen, Thailand
        • Clinical Study Site
      • Lampang, Thailand
        • Clinical Study Site
      • Phitsanulok, Thailand
        • Clinical Study Site
      • Ratchathewi, Thailand
        • Clinical Study Site
      • Udon Thani, Thailand
        • Clinical Study Site
    • Muang
      • Lop Buri, Muang, Thailand
        • Clinical Study Site
    • Songkhla
      • Hat Yai, Songkhla, Thailand
        • Clinical Study Site
  • Turkey
      • Adana, Turkey
        • Clinical Study Site 1
      • Adana, Turkey
        • Clinical Study Site 2
      • Ankara, Turkey
        • Clinical Study Site 1
      • Ankara, Turkey
        • Clinical Study Site 2
      • Ankara, Turkey
        • Clinical Study Site 3
      • Ankara, Turkey
        • Clinical Study Site 4
      • Ankara, Turkey
        • Clinical Study Site 5
      • Edirne, Turkey
        • Clinical Study Site
      • Istanbul, Turkey
        • Clinical Study Site 1
      • Istanbul, Turkey
        • Clinical Study Site 2
      • Istanbul, Turkey
        • Clinical Study Site 3
      • Istanbul, Turkey
        • Clinical Study Site 4
      • Samsun, Turkey
        • Clinical Study Site
      • İzmir, Turkey
        • Clinical Study Site 1
      • İzmir, Turkey
        • Clinical Study Site 2
      • İzmir, Turkey
        • Clinical Study Site 3
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Clinical Study Site
      • Ivano-Frankivs'k, Ukraine
        • Clinical Study Site
      • Kharkiv, Ukraine
        • Clinical Study Site
      • Kherson, Ukraine
        • Clinical Study Site
      • Kiev, Ukraine
        • Clinical Study Site 1
      • Kiev, Ukraine
        • Clinical Study Site 2
      • Kirovohrad, Ukraine
        • Clinical Study Site
      • Kyiv, Ukraine
        • Clinical Study Site 1
      • Kyiv, Ukraine
        • Clinical Study Site 2
      • Vinnytsia, Ukraine
        • Clinical Study Site
      • Zaporozhye, Ukraine
        • Clinical Study Site
      • Úzhgorod, Ukraine
        • Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard-of-care chemotherapy

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
Drug: Pemetrexed
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
Drug: Paclitaxel
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
Drug: Gemcitabine
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
Drug: Cisplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Drug: Carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Experimental: cemiplimab
cemiplimab regimen as monotherapy as per study protocol
Drug: cemiplimab
Patients will be administered cemiplimab as per protocol.
Other Names:
  • REGN2810
  • Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of randomization until the date of death, assessed up to 68 months
From date of randomization until the date of death, assessed up to 68 months
Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
PFS as assessed by a blinded IRC using RECIST 1.1.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rates (ORR)
Time Frame: From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months
The number of patients with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of patients in the efficacy analysis set
From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months
Best overall response (BOR)
Time Frame: From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months
The BOR, as determined by the IRC per RECIST 1.1
From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months
Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
Duration of response will be defined as the time between the date of first response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy or death due to any cause, whichever comes first
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Baseline up to 26 months after treatment
Baseline up to 26 months after treatment
Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)
Time Frame: Baseline up to 26 months after treatment
Baseline up to 26 months after treatment
Incidence of Adverse Events (AEs)
Time Frame: Baseline up to 68 months after treatment
Baseline up to 68 months after treatment
Incidence of serious adverse events (SAEs)
Time Frame: Baseline up to 68 months after treatment
Baseline up to 68 months after treatment
Incidence of deaths
Time Frame: Baseline up to 68 months after treatment
Baseline up to 68 months after treatment
Incidence of laboratory abnormalities
Time Frame: Baseline up to 68 months after treatment
Number of patients with laboratory abnormalities
Baseline up to 68 months after treatment
Measure concentrations of cemiplimab in serum
Time Frame: Baseline up to 68 months after treatment
Maximum Plasma Concentration [Cmax]
Baseline up to 68 months after treatment
Characterize the pharmacokinetics (PK) of cemiplimab
Time Frame: Baseline up to 68 months after treatment
Area Under the Curve [AUC]
Baseline up to 68 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2810-ONC-1624
  • 2016-004407-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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