A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen (CheckMate153)

A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 1428
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Local Institution
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Local Institution
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution
  • Quebec
    • Levis, Quebec, Canada, G6V 3Z1
      • Local Institution
    • Montreal, Quebec, Canada, H3T 1E2
      • Local Institution
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center Pc
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Cancer Center Treatment Center of America
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates
    • Sedona, Arizona, United States, 86336
      • Arizona Oncology Associates
    • Tucson, Arizona, United States, 85704
      • Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer Center
    • Concord, California, United States, 94520-2054
      • Diablo Valley Oncology
    • Fullerton, California, United States, 92835
      • Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center
    • Los Angeles, California, United States, 90095
      • Ucla Hema/Onc-Santa Monica
    • Monterey, California, United States, 93940
      • Pacific Cancer Care
    • Sacramento, California, United States, 95816
      • Sutter Cancer center
    • San Francisco, California, United States, 94117
      • Local Institution
    • San Luis Obispo, California, United States, 93401
      • Central Coast Med Oncology
    • Santa Barbara, California, United States, 93105
      • Sansum Santa Barbara Medical Foundation Clinic
    • Santa Maria, California, United States, 93454
      • Central Coast Med Oncology
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
    • Golden, Colorado, United States, 80401
      • Mountain Blue Cancer Care Center
    • Grand Junction, Colorado, United States, 81501
      • St. Mary'S Hospital Regional Cancer Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Ct Hem Onc Assoc
  • Florida
    • Fort Lauderdale, Florida, United States, 33308-4603
      • Holy Cross Hospital Inc.
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists S.
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
    • Lakeland, Florida, United States, 33805
      • Local Institution - 0031
    • Miami, Florida, United States, 33176
      • Local Institution - 0038
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
    • Orlando, Florida, United States, 32804
      • Cancer Institute Of Florida
    • Pemroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute
    • Pensacola, Florida, United States, 32504
      • Local Institution - 0071
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology/Oncology Associates of the Treasure Coast
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Tampa, Florida, United States, 33612
      • Local Institution - 0108
    • Titusville, Florida, United States, 32796
      • Space Coast Cancer Center
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer Blood Ctr
    • Atlanta, Georgia, United States, 30318
      • Piedmont Hospital
    • Macon, Georgia, United States, 31201
      • Central Georgia Cancer Care, PC
    • Newnan, Georgia, United States, 30265
      • Cancer Treatment Centers of America
    • Savannah, Georgia, United States, 31405
      • Summit Cancer Care
    • Thomasville, Georgia, United States, 31792
      • Lewis Hall Singletary Oncology Center
    • Valdosta, Georgia, United States, 31602
      • Pearlman Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Cancer Center
    • Niles, Illinois, United States, 60714
      • Illinois Cancer Specialists
    • Park Ridge, Illinois, United States, 60068
      • Oncology Specialists
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
    • Skokie, Illinois, United States, 60077
      • Local Institution - 0015
    • Springfield, Illinois, United States, 62794-9678
      • Southern Illinois University School of Medicine
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Local Institution - 0081
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Melvin and Bren Simon Cancer Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Center
    • Louisville, Kentucky, United States, 40202
      • University Medical Center, Inc
    • Paducah, Kentucky, United States, 42003
      • West KY Hematology Oncology Group PSC
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Christus Schumpert Health
  • Maine
    • Brewer, Maine, United States, 04412
      • Local Institution
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Mltry Medical Center
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, P.A.
    • Easton, Maryland, United States, 21601
      • Bay Hematology Oncology
  • Michigan
    • Ann Arbor, Michigan, United States, 48016
      • Michigan Cancer Research Consortinum
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers of Western Michigan
    • Southfield, Michigan, United States, 48075
      • Providence Cancer Center
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Forrest General Cancer Center
    • Jackson, Mississippi, United States, 39202
      • Jackson Oncology Associates, PLLC
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Hematology And Oncology Associates, Ltd
  • Missouri
    • North Kansas City, Missouri, United States, 64116
      • University of Kansas Cancer Center
    • Springfield, Missouri, United States, 65807
      • Mercy Medical Research Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Hematology & Oncology Consultants, P.C.
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Comprehensive Cancer Center of Nevada
    • Reno, Nevada, United States, 89502
      • VA Sierra Nevada Health Care System
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Medical Center
    • Summit, New Jersey, United States, 07091
      • Atlantic Health System
  • New Mexico
    • Albuquerque, New Mexico, United States, 87110
      • Presbyterian Medical Group
  • New York
    • Albany, New York, United States, 12208
      • St. Peters Hospital
    • Brooklyn, New York, United States, 11220
      • Maimonides Medical Center
    • Fresh Meadows, New York, United States, 11366
      • Queens Medical Associates
    • Johnson City, New York, United States, 13790
      • Broome Oncology
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • Mount Kisco, New York, United States, 10549
      • Mount Kisco Medical Group
    • New York, New York, United States, 10032
      • Columbia University Medical Center (CUMC)
    • Nyack, New York, United States, 10960
      • Hematology-Oncology Associates of Rockland
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Randolph Cancer Center
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center
    • Greensboro, North Carolina, United States, 27403
      • Moses Cone Regional Cancer Center
    • Greeville, North Carolina, United States, 27834
      • East Carolina University Leo W. Jenkins Cancer Center
    • Salisbury, North Carolina, United States, 28144
      • W.G. Bill Hefner VA Medical Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Mid Dakota Clinic, PC
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Incorporated
    • Cleveland, Ohio, United States, 44195
      • Local Institution
    • Columbus, Ohio, United States, 43219
      • Zangmeister Cancer Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital Bethlehem
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA
    • Columbia, South Carolina, United States, 29210
      • South Carolina Oncology Associates
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology, PLLC - SCRI - PPDS
    • Germantown, Tennessee, United States, 38138
      • The Jones Clinic, PC
    • Germantown, Tennessee, United States, 38138
      • Cancer Care of WNC
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, P.C.
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37232-0021
      • Henry-Joyce Cancer Center
  • Texas
    • Abilene, Texas, United States, 79606
      • Texas Oncology-Abilene
    • Amarillo, Texas, United States, 79106
      • Texas Oncology - Amarillo
    • Arlington, Texas, United States, 76012
      • Texas Oncology
    • Beaumont, Texas, United States, 77702
      • Texas Oncology-Beaumont
    • Bedford, Texas, United States, 76022
      • Texas Oncology
    • Dallas, Texas, United States, 75230
      • Texas Oncology
    • Dallas, Texas, United States, 75231
      • Texas Oncology
    • Dallas, Texas, United States, 75246
      • Local Institution - 0067
    • Denton, Texas, United States, 76201
      • Texas Oncology
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77090
      • Northwest Cancer Center
    • McAllen, Texas, United States, 78503
      • Texas Oncology
    • Mesquite, Texas, United States, 75150
      • Texas Oncology
    • Midland, Texas, United States, 79701
      • Texas Oncology - Odessa
    • Plano, Texas, United States, 75075
      • Texas Oncology-Plano East
    • San Antonio, Texas, United States, 78212
      • Cancer Care Centers of South Texas
    • Sherman, Texas, United States, 75090
      • Texas Cancer Center - Sherman
    • Waco, Texas, United States, 76712
      • Texas Oncology Cancer Care and Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University Of Virginia Health System.
    • Winchester, Virginia, United States, 22601
      • Shenandoah Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Target Population

• Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
• Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
• Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
• Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
• Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
• Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
• Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
• Experimental therapies when given as separate regimen are considered as separate line of therapy
• Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
• Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
• PS 0 to 1
• PS 2

Exclusion Criteria:

1. Target Disease Exceptions

   • Subjects with active central nervous system (CNS) metastases are excluded
   • Subjects with carcinomatous meningitis

2. Medical History and Concurrent Diseases

   • Subjects with a history of interstitial lung disease
   • Subjects with active, known or suspected autoimmune disease
   • Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents

3. Prohibited Treatments and/or Restricted Therapies

   • Ongoing or planned administration of anti-cancer therapies other than those specified in this study
   • Use of corticosteroids or other immunosuppressive medications

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Nivolumab; Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent	Drug: Nivolumab; Other Names: BMS-936558
Experimental: Cohort B: Nivolumab; Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed	Drug: Nivolumab; Other Names: BMS-936558

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5)	A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Time to Onset of Select Adverse Events (Grade 3-5)	The time from first dose to the first occurrence of any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
Median Time to Resolution of Select Adverse Events (Grade 3-5)	The time from the onset of any select adverse event of interest to its resolution or stabilization. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
The Number of Participants Who Received Immune Modulating Medication (or Hormonal Replacement Therapy) for Any Grade Select Adverse Events	The number of participants receiving medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
The Number of Participants Who Received ≥ 40 mg Prednisone Equivalents for Any Grade Select Adverse Events	The number of participants receiving > 40mg prednisone equivalents for any select adverse event of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
The Total Duration of All Immune Modulating Medications for Any Grade Select Adverse Events	The duration of time participants received medication meant to trigger an immune response for any select Adverse events of interest. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)
The Number of Participants With High Grade (Grade 3-4 and Grade 5) Select Adverse Events	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.	From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Spigel DR, McCleod M, Jotte RM, Einhorn L, Horn L, Waterhouse DM, Creelan B, Babu S, Leighl NB, Chandler JC, Couture F, Keogh G, Goss G, Daniel DB, Garon EB, Schwartzberg LS, Sen R, Korytowsky B, Li A, Aanur N, Hussein MA. Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153). J Thorac Oncol. 2019 Sep;14(9):1628-1639. doi: 10.1016/j.jtho.2019.05.010. Epub 2019 May 20.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2014
• Primary Completion (Actual): October 6, 2021
• Study Completion (Actual): October 6, 2021

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No