Submitted by: Yvette Martha Lopez 2017-07-21 00:00:00 Last Updated by: Yvette Lopez 2019-04-22 12:45:31 Export to PDF

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

PHRR170721-001639

R2810-ONC-1624

2017-CT0409

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

To assess the safety and efficacy of REGN2810 as first-line treatment in patients with advanced or metastatic NSCLC whose tumors express PD-L1.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-06-22 40 2020-10-22 0000-00-00

Ongoing

Institution Classification Region LTO #
Regeneron Pharmaceuticals, Inc. Private Business United States of America N/A
Institution Classification Region LTO #
ICON Clinical Research Services Inc. Private Business NCR CDRR-NCR-CRO-10
Institution Amount Region
Regeneron Pharmaceuticals, Inc. N/A United States of America
Name E-Mail Phone Number Postal Address
Yvette Martha Lopez Yvette.Lopez@iconplc.com +63-2-230-5745 ICON Clinical Research Services Philippines Inc. Salcedo Towers, H.V. Dela Costa St., Salcedo Village, Makati City
Name E-Mail Phone Number Postal Address
Irish Valdez Irish.Valdez@iconplc.com +63 2 230 5736 ICON Clinical Research Services Philippines Inc. Salcedo Towers, H.V. Dela Costa St., Salcedo Village, Makati City
Name Expertise Affiliation
Christina G. Galvez, MD MD St. Luke's Medical Center - Global City
Ma. Noemi Alsay-Uy, MD MD Cebu Doctors' University Hospital
Rosalinda Pulido, MD MD St. Frances Cabrini Medical Center
Jennifer Sandoval-Tan, MD MD Philippine General Hospital
Sullian S. Naval, MD MD Lung Center of the Philippines
Annielyn Beryl Ong-Cornel, MD MD Veterans Memorial Medical Center
Marie Cherry Lynn Samson-Fernando, MD MD Manila Doctors Hospital
Adonis Guancia, MD MD Dr. Pablo O. Torre Memorial Hospital
Felycette Gay Martinez-Lapus, MD MD Davao Doctors Hospital
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Global City N/A
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
St. Frances Cabrini Medical Center N/A
Philippine General Hospital Philippine General Hospital Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
Veterans Memorial Medical Center Veterans Memorial Medical Center Ethics Review Committee
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Dr. Pablo O. Torre Memorial Hospital Dr. Pablo O. Torre Memorial Hospital Research Ethics Review Committee
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee

Advance or Metastatic PD L1 + Non-small Cell Lung Cancer 

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.

  • 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.
  • 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
  • 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
  • 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
  • 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 ]
  • 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 ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of deaths [ Time Frame: Baseline up to 12 months after treatment ]
  • Incidence of laboratory abnormalities [ Time Frame: Baseline up to 12 months after treatment ]
    Number of patients with laboratory abnormalities
  • Measure concentrations of REGN2810 in serum [ Time Frame: Baseline up to 12 months after treatment ]
    Maximum Plasma Concentration [Cmax]
  • Characterize the pharmacokinetics (PK) of REGN2810 [ Time Frame: Baseline up to 12 months after treatment ]
    Area Under the Curve [AUC]

Recruiting

  • Argentina
  • Australia
  • Belarus
  • Brazil
  • Bulgaria
  • Chile
  • China
  • Czech Republic
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Malaysia
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • Taiwan
  • Thailand
  • Turkey
  • Ukraine

Clinical Trial

2017-CT0409

2017-06-22

None

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
  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

Interventional

REGN2810

REGN2810 will be administered at 350 mg as an IV infusion Q3W for up to
108 weeks.

The study will consist of the following 3 periods: screening, treatment, and follow-up. Patients will undergo a screening evaluation to determine their eligibility within 28 days prior to randomization. Eligible patients will be randomized to one of the following 2 treatment groups: REGN2810 350 mg monotherapy or standard-of-care chemotherapy. Randomization will be stratified by histology (non-squamous versus squamous) and geographic region (EU or
ROW). Patients with NSCLC randomized to chemotherapy may receive one of the
following regimens:
 
 Paclitaxel + cisplatin or carboplatin
 Gemcitabine + cisplatin or carboplatin
 Pemetrexed + cisplatin or carboplatin followed by optional pemetrexed maintenance (it is recommended that patients with squamous NSCLC not be given pemetrexed-containing regimens)
 
Patients assigned to the REGN2810 treatment group will receive REGN2810 350 mg as an intravenous (IV) infusion on day 1 of every treatment cycle (every 3 weeks [Q3W]) for up to 108 weeks or until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined progressive disease, unacceptable toxicity, death, or withdrawal of consent. REGN2810 patients who experience RECIST 1.1-defined progressive disease on therapy may continue treatment with REGN2810 if the investigator judges the patient to be experiencing clinical benefit and if the patient has not completed the 108-week treatment period. If further progressive disease (defined as an additional 10% increase in tumor burden from the time of initial progressive disease) is confirmed, REGN2810 must be discontinued and other anticancer therapy considered, if appropriate.
 
Patients assigned to chemotherapy will receive one of the protocol given options of platinum-doublet chemotherapy treatment for up to 4 to 6 cycles or until RECIST 1.1-defined progressive disease, unacceptable toxicity, death, or withdrawal of consent. Patients who experience disease progression while on chemotherapy will be offered the option to crossover to receive REGN2810 350 mg Q3W for up to 108 weeks, provided they meet specific criteria.
 
Patients will have follow-up visits every 6 weeks for 6 months and then at 9 months and 12 months after the last dose of treatment.

Randomized

Open Label

Unspecified

Crossover

To assess the safety and efficacy of REGN2810 as first-line treatment in patients with advanced or metastatic NSCLC whose tumors express PD-L1.

Phase III

50

Unspecified

Unspecified

22 Jun 2017

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