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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088540
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
To assess the safety and efficacy of cemiplimab as first-line treatment in patients with advanced or metastatic NSCLC whose tumors express PD-L1.

Condition or disease Intervention/treatment Phase
Carcinoma,Non-Small-Cell Lung Lung Carcinomas, Non-Small-Cell Non-small-cell Lung Carcinoma Nonsmall Cell Lung Cancer Drug: Pemetrexed Drug: Paclitaxel Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Drug: cemiplimab Phase 3

Detailed Description:
There is option to join genomics sub-study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: REGN2810




Primary Outcome Measures :
  1. 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 30 months ]
    PFS as assessed by a blinded IRC using RECIST 1.1.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From date of randomization until date of death, assessed up to 39 months ]
    Overall survival will be defined as the time from randomization to the date of death.

  2. 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 30 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

  3. Best overall response (BOR) [ 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 30 months ]
    The BOR, as determined by the IRC per RECIST 1.1

  4. 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 30 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

  5. Assess quality of life (QOL) of patients treated with cemiplimab versus patients receiving platinum-based chemotherapies as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline up to 30 days after treatment ]
  6. Change From Baseline in Quality of Life as measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Baseline up to 30 days after treatment ]
  7. Incidence of Adverse Events (AEs) [ Time Frame: Baseline up to 12 months after treatment ]
  8. Incidence of serious adverse events (SAEs) [ Time Frame: Baseline up to 12 months after treatment ]
  9. Incidence of deaths [ Time Frame: Baseline up to 12 months after treatment ]
  10. Incidence of laboratory abnormalities [ Time Frame: Baseline up to 12 months after treatment ]
    Number of patients with laboratory abnormalities

  11. Measure concentrations of cemiplimab in serum [ Time Frame: Baseline up to 12 months after treatment ]
    Maximum Plasma Concentration [Cmax]

  12. Characterize the pharmacokinetics (PK) of cemiplimab [ Time Frame: Baseline up to 12 months after treatment ]
    Area Under the Curve [AUC]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 who are unwilling to practice highly effective contraception prior to the initial dose, during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088540


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

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

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03088540     History of Changes
Other Study ID Numbers: R2810-ONC-1624
2016-004407-31 ( EudraCT Number )
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Previous Smoker
Current Smoker
Stage IIIB
Stage IIIC
Stage IV
PD-L1
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Cemiplimab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents