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NCT02453282Active, not recruitingPhase 3

Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1118 (actual)
First submitted
20 May 2015
Start date
21 Jul 2015
Primary completion date
4 Oct 2018
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT02453282
EudraCT number
2015-001279-39

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1118
  • From 21 Jul 2015 to the primary completion date, 4 Oct 2018
  • 164 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\]

Other illness

  • Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

Lab values

  • Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines

Other

  • Patients should not enter the study if any of the following exclusion criteria are fulfilled:

Who the study is looking for

  • For inclusion in the study, patients should fulfill the following criteria:
  • Aged at least 18 years
  • Documented evidence of Stage IV NSCLC
  • No sensitizing EGFR mutation or ALK rearrangement
  • No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  • World Health Organization (WHO) Performance Status of 0 or 1

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (164)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Box HillAustraliaUnknown status
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GosfordAustraliaUnknown status
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KogarahAustraliaUnknown status
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MelbourneAustraliaUnknown status
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Port MacquarieAustraliaUnknown status
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SouthportAustraliaUnknown status
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St LeonardsAustraliaUnknown status
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BrusselsBelgiumUnknown status
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CharleroiBelgiumUnknown status
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DuffelBelgiumUnknown status
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LeuvenBelgiumUnknown status
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LiègeBelgiumUnknown status
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Greater SudburyCanadaUnknown status
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KingstonCanadaUnknown status
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NewmarketCanadaUnknown status
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OshawaCanadaUnknown status
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ReginaCanadaUnknown status
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Saint CatherinesCanadaUnknown status
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SaskatoonCanadaUnknown status
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Sault Ste. MarieCanadaUnknown status
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TorontoCanadaUnknown status
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BellinzonaSwitzerlandUnknown status
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LausanneSwitzerlandUnknown status
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AachenGermanyUnknown status
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Bad BerkaGermanyUnknown status
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BerlinGermanyUnknown status
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Freiburg im BreisgauGermanyUnknown status
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GautingGermanyUnknown status
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HamburgGermanyUnknown status
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HeidelbergGermanyUnknown status
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HemerGermanyUnknown status
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Homburg/SaarGermanyUnknown status
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ImmenhausenGermanyUnknown status
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LöwensteinGermanyUnknown status
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LübeckGermanyUnknown status
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MainzGermanyUnknown status
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MünsterGermanyUnknown status
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OldenburgGermanyUnknown status
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UlmGermanyUnknown status
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VelbertGermanyUnknown status
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WürzburgGermanyUnknown status
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A CoruñaSpainUnknown status
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AlicanteSpainUnknown status
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BarcelonaSpainUnknown status
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GironaSpainUnknown status
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JaénSpainUnknown status
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LeónSpainUnknown status
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MadridSpainUnknown status
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MajadahondaSpainUnknown status
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MálagaSpainUnknown status
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SevilleSpainUnknown status
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ValenciaSpainUnknown status
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BordeauxFranceUnknown status
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BrestFranceUnknown status
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CréteilFranceUnknown status
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LilleFranceUnknown status
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LyonFranceUnknown status
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MarseilleFranceUnknown status
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BudapestHungaryUnknown status
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DeszkHungaryUnknown status
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EdelényHungaryUnknown status
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KaposvárHungaryUnknown status
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KecskemétHungaryUnknown status
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MiskolcHungaryUnknown status
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NyíregyházaHungaryUnknown status
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PécsHungaryUnknown status
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SzékesfehérvárHungaryUnknown status
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GenovaItalyUnknown status
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MeldolaItalyUnknown status
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MilanItalyUnknown status
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San Giovanni RotondoItalyUnknown status
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SienaItalyUnknown status
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FukushimaJapanUnknown status
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Himeji-shiJapanUnknown status
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Hirakata-shiJapanUnknown status
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Hirosaki-shiJapanUnknown status
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Iizuka-shiJapanUnknown status
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Iwakuni-shiJapanUnknown status
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Izumi-shiJapanUnknown status
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KanazawaJapanUnknown status
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Kishiwada-shiJapanUnknown status
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KobeJapanUnknown status
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Koga-shiJapanUnknown status
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KyotoJapanUnknown status
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Mitaka-shiJapanUnknown status
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Nagaoka-shiJapanUnknown status
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NagoyaJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SagaJapanUnknown status
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Saitama-shiJapanUnknown status
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SakaishiJapanUnknown status
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SayamaJapanUnknown status
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SendaiJapanUnknown status
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Shinjuku-kuJapanUnknown status
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TokushimaJapanUnknown status
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Ube-shiJapanUnknown status
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YokohamaJapanUnknown status
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Yokosuka-shiJapanUnknown status
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BusanSouth KoreaUnknown status
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Changwon-siSouth KoreaUnknown status
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Cheongju-siSouth KoreaUnknown status
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DaeguSouth KoreaUnknown status
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DaejeonSouth KoreaUnknown status
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Goyang-siSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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JinjuSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SuwonSouth KoreaUnknown status
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UlsanSouth KoreaUnknown status
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AmsterdamNetherlandsUnknown status
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ArnhemNetherlandsUnknown status
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BredaNetherlandsUnknown status
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GroningenNetherlandsUnknown status
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MaastrichtNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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's-HertogenboschNetherlandsUnknown status
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MoscowRussiaUnknown status
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ObninskRussiaUnknown status
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OmskRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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BangkokThailandUnknown status
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Chiang MaiThailandUnknown status
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Hat YaiThailandUnknown status
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Khon KaenThailandUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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AthensUnited StatesUnknown status
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BakersfieldUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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FullertonUnited StatesUnknown status
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HonoluluUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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La JollaUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MadisonUnited StatesUnknown status
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MineolaUnited StatesUnknown status
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MinneapolisUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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North CharlestonUnited StatesUnknown status
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OmahaUnited StatesUnknown status
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Pembroke PinesUnited StatesUnknown status
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Redondo BeachUnited StatesUnknown status
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RichmondUnited StatesUnknown status
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SacramentoUnited StatesUnknown status
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San Luis ObispoUnited StatesUnknown status
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Santa MariaUnited StatesUnknown status
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ScottsdaleUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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SummitUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TucsonUnited StatesUnknown status
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West HollywoodUnited StatesUnknown status
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YumaUnited StatesUnknown status
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HanoiVietnamUnknown status
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Ho Chi Minh CityVietnamUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.