Sponsor: Dizal Pharmaceuticals (industry)
Phase: 3
Start date: Dec. 13, 2022
Planned enrollment: 320
Last updated in HealthScout: Dec 2024
Sunvozertinib, also known as DZD9008, is an investigational oral tyrosine kinase inhibitor (TKI) targeting non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. (onclive.com)
Sunvozertinib is a selective and irreversible inhibitor of EGFR exon 20 insertion mutations, designed to maintain selectivity over wild-type EGFR. (biospace.com)
In the phase 2 WO-KONH6 study, sunvozertinib demonstrated an objective response rate (ORR) of 60.8% in patients with EGFR exon 20 insertion–mutated NSCLC who had progressed on prior platinum-based chemotherapy. (onclive.com)
Sunvozertinib exhibited a safety profile similar to other EGFR TKIs. Common treatment-emergent adverse events included diarrhea (67.3%), increased blood creatine phosphokinase (57.7%), rash (53.8%), and anemia (49.0%). Most adverse events were grade 1 or 2 and clinically manageable. (cancernetwork.com)
Last updated: Apr 2025
Last updated: Apr 2025
Goal: The aim of this clinical trial is to evaluate the efficacy and safety of DZD9008, an investigational oral EGFR tyrosine kinase inhibitor, compared to standard platinum-based doublet chemotherapy as first-line treatment in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion mutation.
Patients: The trial is focused on adult patients with a histologically confirmed diagnosis of non-squamous NSCLC that is either locally advanced or metastatic. These patients must have an EGFR exon 20 insertion mutation confirmed through central laboratory testing, be treatment-naïve for advanced stages, and demonstrate a measurable lesion according to RECIST 1.1. Additionally, participants must have a life expectancy of twelve weeks or more and an ECOG performance status of 0 to 1.
Design: This is a Phase 3, open-label, randomized, multi-center study involving approximately 320 participants. Patients are randomized in a 1:1 ratio to receive either DZD9008 or platinum-based doublet chemotherapy, with stratification based on the presence or absence of baseline brain metastasis.
Treatments: The experimental arm of the trial consists of the investigational drug DZD9008, also known as Sunvozertinib, which is a selective, irreversible EGFR tyrosine kinase inhibitor that specifically targets the exon 20 insertion mutations in EGFR. Previous trials have shown an objective response rate of 53.3% and demonstrated efficacy across various subgroups. The comparator arm involves Pemexetred and carboplatin, which are standard chemotherapy agents used in NSCLC.
Outcomes: The primary outcome measured in this study is Progression-Free Survival (PFS) assessed by a Blinded Independent Central Review, following RECIST 1.1 criteria. The secondary outcome is Overall Survival. Both outcomes will be assessed approximately 34 months post-randomization of the first participant.
Burden on patient: Overall, the study imposes a low to moderate burden on participants. While there are requirements for sufficient tumor tissue for mutation confirmation and regular follow-up assessments for progression and survival metrics, DZD9008 being an oral agent reduces the need for frequent hospital visits typically associated with intravenous chemotherapy. The trial's follow-up involves regular scans, which align with standard care practices, further minimizing additional burden.
Inclusion Criteria:
1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function
Exclusion Criteria:
1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).
Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Status: Completed
Buenos Aires, Argentina
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Status: Completed
Buenos Aires, Argentina
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Buenos Aires, Argentina
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Status: Completed
Viedma, Argentina
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San Salvador, Argentina
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Status: Completed
Rosario, Argentina
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Status: Completed
Buenos Aires, Argentina
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Status: Completed
Randwick, Australia
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Nedlands, Australia
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Melbourne, Australia
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Concord, Australia
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Salzburg, Austria
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Linz, Austria
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Edegem, Antwerp, Belgium
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Ghent, Flanders, Belgium
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Charleroi, Hainaut, Belgium
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Barretos, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Rio De Janeiro, Brazil
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Rio De Janeiro, Brazil
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Rio De Janeiro, Brazil
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São Paulo, Brazil
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Cachoeiro De Itapemirim, Brazil
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Status: Recruiting
Ottawa, Canada
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Toronto, Canada
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London, Canada
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Guangzhou, China
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Beijing, China
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Beijing, China
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Status: Recruiting
Beijing, China
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Status: Recruiting
Beijing, China
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Status: Recruiting
Beijing, China
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Status: Completed
Changsha, China
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Status: Recruiting
Chengdu, China
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Status: Recruiting
Chongqing, China
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Status: Not yet recruiting
Chongqing, China
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Status: Recruiting
Fuzhou, China
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Status: Recruiting
Fuzhou, China
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Status: Recruiting
Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Status: Recruiting
Hefei, China
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Status: Recruiting
Hefei, China
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Status: Recruiting
Hohhot, China
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Status: Completed
Jilin, China
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Status: Recruiting
Jinan, China
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Status: Recruiting
Jinan, China
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Kunming, China
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Nanchang, China
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Nanjing, China
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Nanjing, China
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Nanning, China
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Shanghai, China
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Status: Recruiting
Shanghai, China
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Shanghai, China
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Status: Recruiting
Shenyang, China
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Status: Recruiting
Shenzhen, China
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Status: Completed
Shijiazhuang, China
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Status: Recruiting
Taiyuan, China
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Status: Recruiting
Taizhou, China
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Tianjin, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Yantai, China
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Zhengzhou, China
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Zhengzhou, China
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Ostrava, Czechia
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Olomouc, Czechia
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Saint-Mande, France
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Status: Recruiting
Saint Herblain, France
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Saint Herblain, France
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Status: Recruiting
Poitiers, France
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Status: Recruiting
Paris, France
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Status: Recruiting
Paris, France
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Status: Not yet recruiting
Paris, France
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Status: Recruiting
Paris, France
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Status: Recruiting
Montpellier, France
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Marseille, France
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La Tronche, France
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Hellemmes-Lille, France
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Status: Recruiting
Créteil, France
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Bron, France
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Angers, France
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Status: Recruiting
Suresnes, France
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Status: Recruiting
Mainz, Germany
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Berlin, Germany
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Gauting, Germany
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Georgsmarienhütte, Germany
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Heidelberg, Germany
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Oldenburg, Germany
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Reggio Emilia, Italy
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Siena, Italy
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Status: Recruiting
Roma, Italy
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Meldola, Italy
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Modena, Italy
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Monza, Italy
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Palermo, Italy
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Parma, Italy
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Status: Recruiting
Ravenna, Italy
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Status: Recruiting
Florence, Italy
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Status: Recruiting
Aviano, Italy
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Bologna, Italy
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Status: Recruiting
Catania, Italy
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Status: Recruiting
Grosseto, Italy
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Status: Recruiting
Maastricht, Netherlands
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Status: Not yet recruiting
Gdańsk, Poland
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Status: Recruiting
Przemyśl, Poland
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Warsaw, Poland
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Poznań, Poland
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Madrid, Spain
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Málaga, Spain
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Sevilla, Spain
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Sevilla, Spain
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Sevilla, Spain
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Valencia, Spain
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Valencia, Spain
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A Coruña, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Girona, Spain
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Jerez De La Frontera, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Ankara, Turkey
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Ankara, Turkey
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Konya, Turkey
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Kadıköy, Turkey
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Istanbul, Turkey
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Edirne, Turkey
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Status: Recruiting
Ankara, Turkey
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Ankara, Turkey
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Status: Recruiting
Vallejo, California, 94589, United States
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Status: Recruiting
Glendale, California, 91203, United States
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Status: Recruiting
Aurora, Colorado, 80045, United States
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Status: Recruiting
Margate, Florida, 33054, United States
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Status: Recruiting
Tampa, Florida, 33612, United States
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Status: Not yet recruiting
Plantation, Florida, 33324, United States
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Status: Recruiting
New York, New York, 10032, United States
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Status: Recruiting
New York, New York, 10016, United States
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Status: Recruiting
Columbus, Ohio, 43210, United States
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Status: Recruiting
Canton, Ohio, 44718, United States
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Status: Recruiting
Portland, Oregon, 97213, United States
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Status: Completed
Houston, Texas, 77030, United States
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Status: Recruiting
Weslaco, Texas, 78596, United States
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Status: Recruiting
Dallas, Texas, 75246, United States
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Status: Recruiting
Charlottesville, Virginia, 22908, United States
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Status: Recruiting