Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer (NILE)

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Urothelial Cancer; Unresectable Locally Advanced Urothelial Cancer
• Intervention / Treatment: Drug: Durvalumab; Drug: Tremelimumab; Drug: Cisplatin + Gemcitabine; Drug: Carboplatin + Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 1246
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad de Buenos Aires, Argentina, 1280
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1419AHL
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1426ANZ
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1120AAT
    • Research Site
  • Rosario, Argentina, S2000DEJ
    • Research Site
• Australia
  • Box Hill, Australia, 3128
    • Research Site
  • Elizabeth Vale, Australia, 5112
    • Research Site
  • Kogarah, Australia, 2217
    • Research Site
  • Macquarie University, Australia, 2109
    • Research Site
  • Murdoch, Australia, 6150
    • Research Site
  • Orange, Australia, 2800
    • Research Site
  • South Brisbane, Australia, 4101
    • Research Site
  • St Albans, Australia, 3021
    • Research Site
• Brazil
  • Curitiba, Brazil, 80810-050
    • Research Site
  • Fortaleza, Brazil, 60336-232
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Research Site
  • Porto Alegre, Brazil, 90020-090
    • Research Site
  • Ribeirão Preto, Brazil, 14048-900
    • Research Site
  • Rio de Janeiro, Brazil, 22793-080
    • Research Site
  • Rio de Janeiro, Brazil, 20231-050
    • Research Site
  • Salvador, Brazil, 41.950-610
    • Research Site
  • Santa Maria, Brazil, 97015-450
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 01246-000
    • Research Site
  • São Paulo, Brazil, 01327-001
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Research Site
  • Plovdiv, Bulgaria, 4000
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1527
    • Research Site
  • Sofia, Bulgaria, 1797
    • Research Site
  • Sofia, Bulgaria, 1303
    • Research Site
  • Varna, Bulgaria, 9010
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Research Site
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Site
    • Toronto, Ontario, Canada, M5G IX6
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Site
• China
  • Beijing, China, 100730
    • Research Site
  • Beijing, China, 100034
    • Research Site
  • Beijing, China, 100191
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Changsha, China, 410008
    • Research Site
  • Chongqing, China, 400038
    • Research Site
  • Chongqing, China, 400042
    • Research Site
  • Dalian, China, 116027
    • Research Site
  • Guangzhou, China, 510000
    • Research Site
  • Guangzhou, China, 510060
    • Research Site
  • Hangzhou, China, 310022
    • Research Site
  • Hangzhou, China, 310003
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Hangzhou, China, 310014
    • Research Site
  • Jinan, China, 250012
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 2100008
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200072
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Suzhou, China, 215006
    • Research Site
  • Tianjin, China
    • Research Site
  • Tianjin, China, 300211
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Xi'an, China, 710061
    • Research Site
  • Ürümqi, China, 830000
    • Research Site
• Czechia
  • Brno, Czechia, 656 91
    • Research Site
  • Hradec Králové, Czechia, 500 05
    • Research Site
  • Olomouc, Czechia, 77900
    • Research Site
  • Ostrava, Czechia, 708 52
    • Research Site
  • Prague, Czechia, 128 08
    • Research Site
  • Prague, Czechia, 140 59
    • Research Site
  • Prague, Czechia, 180 81
    • Research Site
• Hungary
  • Budapest, Hungary, 1145
    • Research Site
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1062
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Győr, Hungary, 9024
    • Research Site
  • Kecskemét, Hungary, 6000
    • Research Site
  • Szolnok, Hungary, 5000
    • Research Site
• India
  • Gurgaon, India, 122001
    • Research Site
  • Hubli, India, 580025
    • Research Site
  • Kolkata, India, 700160
    • Research Site
  • Mysuru, India, 570017
    • Research Site
  • Nagpur, India, 440012
    • Research Site
  • Nashik, India, 422005
    • Research Site
  • New Delhi, India, 110085
    • Research Site
  • New Delhi, India, 11029
    • Research Site
  • Pune, India, 411004
    • Research Site
• Israel
  • Haifa, Israel, 31096
    • Research Site
  • Jerusalem, Israel, 91120
    • Research Site
  • Kfar Saba, Israel, 95847
    • Research Site
  • Petah Tikva, Israel, 4941492
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
• Italy
  • Arezzo, Italy, 52100
    • Research Site
  • Milan, Italy, 20132
    • Research Site
  • Milan, Italy, 20133
    • Research Site
  • Naples, Italy, 80131
    • Research Site
  • Orbassano, Italy, 10043
    • Research Site
  • Parma, Italy, 43126
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Roma, Italy, 00100
    • Research Site
  • Terni, Italy, 05100
    • Research Site
  • Verona, Italy, 37134
    • Research Site
• Japan
  • Bunkyō City, Japan, 113-8603
    • Research Site
  • Chūōku, Japan, 104-0045
    • Research Site
  • Fukuoka, Japan, 811-1347
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
    • Research Site
  • Kanazawa, Japan, 920-8641
    • Research Site
  • Kita-gun, Japan, 761-0793
    • Research Site
  • Koshigaya-shi, Japan, 343-8555
    • Research Site
  • Kumamoto, Japan, 860-8556
    • Research Site
  • Kumamoto, Japan, 860-0008
    • Research Site
  • Kyoto, Japan, 606-8507
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Research Site
  • Miyazaki, Japan, 889-1692
    • Research Site
  • Nagasaki, Japan, 852-8501
    • Research Site
  • Nagoya, Japan, 466-8560
    • Research Site
  • Nagoya, Japan, 467-0001
    • Research Site
  • Niigata, Japan, 951-8520
    • Research Site
  • Osaka, Japan, 545-8586
    • Research Site
  • Osaka, Japan, 541-8567
    • Research Site
  • Osakasayama-shi, Japan, 589-8511
    • Research Site
  • Shinjuku-ku, Japan, 160-8582
    • Research Site
  • Suita-shi, Japan, 565-0871
    • Research Site
  • Toyama, Japan, 930-0194
    • Research Site
  • Yokohama, Japan, 241-8515
    • Research Site
  • Yokohama, Japan, 232-0024
    • Research Site
• Philippines
  • Bacolod, Philippines, 6100
    • Research Site
  • Baguio City, Philippines, 2600
    • Research Site
  • Cebu, Philippines, 6000
    • Research Site
  • Davao City, Philippines, 8000
    • Research Site
  • Makati, Philippines, 1229
    • Research Site
  • Manila, Philippines, 1015
    • Research Site
  • Quezon City, Philippines, 1104
    • Research Site
  • Quezon City, Philippines, 1101
    • Research Site
• Poland
  • Bialystok, Poland, 15-027
    • Research Site
  • Gdansk, Poland, 80-952
    • Research Site
  • Grudziądz, Poland, 86-300
    • Research Site
  • Koszalin, Poland, 75-581
    • Research Site
  • Krakow, Poland, 31-501
    • Research Site
  • Olsztyn, Poland, 10-228
    • Research Site
  • Poznan, Poland, 60-693
    • Research Site
  • Radom, Poland, 26-600
    • Research Site
  • Warsaw, Poland, 02-781
    • Research Site
• Russia
  • Ivanovo, Russia, 153040
    • Research Site
  • Krasnoyarsk, Russia, 660133
    • Research Site
  • Moscow, Russia, 105229
    • Research Site
  • Moscow, Russia, 125284
    • Research Site
  • Moscow, Russia, 105077
    • Research Site
  • Moscow, Russia, 115280
    • Research Site
  • Nizhny Novgorod, Russia, 603074
    • Research Site
  • Nizhny Novgorod, Russia, 603137
    • Research Site
  • Omsk, Russia, 644013
    • Research Site
  • Rostov-on-Don, Russia, 344037
    • Research Site
  • Saint Petersburg, Russia, 197758
    • Research Site
  • Saint Petersburg, Russia, 199178
    • Research Site
  • Saint Petersburg, Russia, 195067
    • Research Site
  • Tyumen, Russia, 625041
    • Research Site
  • Vologda, Russia, 160012
    • Research Site
• South Korea
  • Goyang-si, South Korea, 10408
    • Research Site
  • Incheon, South Korea, 21565
    • Research Site
  • Seoul, South Korea, 02841
    • Research Site
  • Seoul, South Korea, 03722
    • Research Site
  • Seoul, South Korea, 05505
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
  • Suwon, South Korea, 16247
    • Research Site
• Spain
  • Barcelona, Spain, 8035
    • Research Site
  • Barcelona, Spain, 08908
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Lugo, Spain, 27003
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Santander, Spain, 39008
    • Research Site
  • Seville, Spain, 41013
    • Research Site
• Taiwan
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 404
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taipei, Taiwan, 10050
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
• Thailand
  • Bangkok, Thailand, 10300
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
  • Mueang, Thailand, 50200
    • Research Site
  • Songkhla, Thailand, 90110
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1260
    • Research Site
  • Adapazarı, Turkey (Türkiye), 54290
    • Research Site
  • Ankara, Turkey (Türkiye), 06590
    • Research Site
  • Edirne, Turkey (Türkiye), 22030
    • Research Site
  • Istanbul, Turkey (Türkiye), 34030
    • Research Site
  • Izmir, Turkey (Türkiye)
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Fullerton, California, United States, 92835
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Salinas, California, United States, 93901
      • Research Site
    • Santa Barbara, California, United States, 93105
      • Research Site
    • Truckee, California, United States, 96161
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Research Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Research Site
  • Florida
    • Orlando, Florida, United States, 32806
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Research Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Research Site
  • Montana
    • Bozeman, Montana, United States, 59715
      • Research Site
  • New York
    • New Hyde Park, New York, United States, 11042
      • Research Site
    • New York, New York, United States, 10065
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • Rochester, New York, United States, 14642
      • Research Site
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Research Site
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site
  • Hà Nội, Vietnam, 100000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)
• Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment].
• At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
• Adequate organ and marrow function as defined in the protocol
• Life expectancy ≥12 weeks in the opinion of the investigator
• Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

Key Exclusion Criteria:

• Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
• No severe concomitant condition that requires immunosuppression medication
• Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
• Patients who may be eligible for or are being considered for radical resection during the course of the study.
• Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Durvalumab in Combination with SoC Chemotherapy; Durvalumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: cisplatin+ gemcitabine; If the patient is cisplatin-ineligible, carboplatin + gemcitabine	Drug: Durvalumab; Durvalumab IV (intravenous infusion); Other Names: MEDI4736; Drug: Cisplatin + Gemcitabine; Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.; Drug: Carboplatin + Gemcitabine; Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Experimental: Durvalumab in Combination with Tremelimumab+SoC Chemotherapy; Durvalumab and Tremelimumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks Tremelimumab will be provided for 4 cycles. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: cisplatin+ gemcitabine; If the patient is cisplatin-ineligible, carboplatin + gemcitabine	Drug: Durvalumab; Durvalumab IV (intravenous infusion); Other Names: MEDI4736; Drug: Tremelimumab; Tremelimumab IV (intravenous infusion); Drug: Cisplatin + Gemcitabine; Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.; Drug: Carboplatin + Gemcitabine; Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
Active Comparator: SoC Chemotherapy; Patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: cisplatin+ gemcitabine; If the patient is cisplatin-ineligible, carboplatin + gemcitabine	Drug: Cisplatin + Gemcitabine; Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.; Drug: Carboplatin + Gemcitabine; Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization until death due to any cause	approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Additional analysis beyond the primary endpoint	approximately 5 years
Overall Survival at 24 months (OS24)	The OS24 will be defined as the Kaplan-Meier estimate of OS at 24 months	24 months
Progression Free Survival (PFS)	PFS (per RECIST 1.1) will be defined as the time from the date of randomization until the date of first objective disease progression or death	approximately 5 years
Alive and Progression Free Survival at 12 months (APF12)	The APF12 will be defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1) at 12 months	12 months
Objective Response Rate (ORR)	ORR (per RECIST 1.1) is defined as the number (%) of patients with at least 1 visit response of complete response or partial response and will be based on a subset of all randomized patients	approximately 5 years
Duration of Response (DoR)	DoR (per RECIST 1.1) will be defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression	approximately 5 years
Disease Control Rate (DCR)	DCR is defined as the proportion of subjects with the best overall response of complete response, partial response or stable disease per RECIST 1.1	approximately 5 years
Time from randomization to second (PFS2)	PFS2 will be defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the PFS endpoint or death	approximately 5 years
To assess disease-related symptoms, physical functioning, and other Health-related quality of life	Collection of patient reported outcome questionnaires	approximately 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess safety using a summary of adverse events.	Adverse Events (both in terms of MedDRA preferred terms and CTCAE grade) will be listed individually by patient. The number of patients experiencing each Adverse Event will be summarized by treatment arm and CTCAE grade	approximately 5 years
To assess pharmacokinetics of Durvalumab and Tremelimumab	Serum concentrations of Durvalumab and Tremelimumab	approximately 5 years
To assess immunogenicity of Durvalumab and Tremelimumab	Presence of anti-drug antibodies for Durvalumab and Tremelimumab	approximately 5 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: bladder cancer; urethra; urinary bladder; renal pelvis; ureters
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Gemcitabine; Carboplatin; Cisplatin; durvalumab; tremelimumab
• Other Study ID Numbers: D933SC00001; 2018-001883-48 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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