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

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ClinicalTrials.gov Identifier: NCT03088540
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
To assess the safety and efficacy of REGN2810 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: REGN2810 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : September 6, 2021
Estimated Study Completion Date : September 6, 2021

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: REGN2810
REGN2810 regimen as monotherapy as per study protocol
Drug: REGN2810
Patients will be administered REGN2810 as per protocol.




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 REGN2810 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 REGN2810 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 REGN2810 in serum [ Time Frame: Baseline up to 12 months after treatment ]
    Maximum Plasma Concentration [Cmax]

  12. Characterize the pharmacokinetics (PK) of REGN2810 [ Time Frame: Baseline up to 12 months after treatment ]
    Area Under the Curve [AUC]



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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

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 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

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 informed consent
  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
  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. Known active hepatitis B (positive result) or hepatitis C (known positive result) and known quantitative HCV RNA results greater than the lower limits of detection of the assay)
  10. Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome indicating uncontrolled active infection. Patients on highly active antiretroviral therapy with undetectable RNA levels and CD4 counts above 350 are permitted
  11. Active infection requiring systemic therapy within 14 days prior to randomization
  12. Prior therapy with anti-PD 1 or anti-PD L1
  13. Treatment-related immune-mediated AEs from immune-modulatory agents
  14. Receipt of an investigational drug or device within 30 days
  15. Receipt of a live vaccine within 30 days of planned start of study medication
  16. Major surgery or significant traumatic injury within 4 weeks prior to first dose
  17. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
  18. Known allergy to doxycycline or other tetracycline antibiotics
  19. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
  20. Pregnant or breastfeeding women
  21. 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
  22. Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities will be excluded from this study

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

  Show 136 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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 1, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors