Sponsor: Dizal Pharmaceuticals (industry)
Phase: 3
Start date: Dec. 13, 2022
Planned enrollment: 320
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
Goal: To compare the efficacy and safety of DZD9008 (sunvozertinib), an oral selective EGFR exon 20 insertion inhibitor, versus standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Patients: Adults with histologically or cytologically confirmed non-squamous, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC, with centrally confirmed EGFR exon 20 insertion mutation, ECOG performance status 0–1, and no prior systemic therapy for advanced disease.
Design: This is a phase 3, open-label, randomized multi-center trial enrolling approximately 320 patients. Participants are randomized 1:1 to either DZD9008 or platinum-based doublet chemotherapy, stratified by the presence or absence of baseline brain metastases.
Treatments: The investigational arm receives sunvozertinib (DZD9008), an irreversible EGFR tyrosine kinase inhibitor with high selectivity for EGFR exon 20 insertion mutations and lower off-target activity against wild-type EGFR, designed to improve efficacy and reduce toxicity relative to earlier EGFR inhibitors. Prior phase 2 results demonstrated an objective response rate of 44.9–53.3% and clinically manageable side effects, principally low-grade diarrhea and rash. The control arm receives standard platinum-based doublet chemotherapy (pemetrexed plus carboplatin), which is a guideline-based first-line regimen for non-squamous NSCLC.
Outcomes: The primary outcome is progression-free survival assessed by blinded independent central review per RECIST 1.1. Key secondary outcomes include overall survival. Both endpoints will be evaluated up to approximately 34 months from the first patient’s randomization.
Burden on patient: The trial is expected to impose a low to moderate burden on participants. As a phase 3 study, the schedule of assessments and imaging will be similar to standard care in advanced NSCLC, likely involving periodic scans and routine laboratory monitoring. There are no requirements for frequent pharmacokinetic monitoring or additional invasive procedures beyond baseline tumor tissue for central EGFR mutation confirmation, minimizing extra appointments or interventions beyond standard oncology practice.
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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Status: Not yet recruiting
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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Status: Completed
Buenos Aires, Argentina
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Status: Not yet recruiting
Viedma, Argentina
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Status: Not yet recruiting
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
Buenos Aires, Argentina
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Status: Not yet recruiting
Buenos Aires, Argentina
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Status: Not yet recruiting
Randwick, Australia
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Status: Recruiting
Nedlands, Australia
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Status: Recruiting
Melbourne, Australia
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Concord, Australia
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Salzburg, Austria
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Linz, Austria
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Status: Recruiting
Edegem, Antwerp, Belgium
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Ghent, Flanders, Belgium
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Charleroi, Hainaut, Belgium
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Status: Recruiting
Barretos, Brazil
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Status: Recruiting
Porto Alegre, Brazil
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Status: Recruiting
Porto Alegre, Brazil
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Status: Recruiting
Recife, Brazil
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Status: Recruiting
Rio De Janeiro, Brazil
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Status: Recruiting
Rio De Janeiro, Brazil
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Status: Recruiting
São Paulo, Brazil
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Status: Recruiting
Rio De Janeiro, Brazil
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Cachoeiro De Itapemirim, Brazil
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Status: Recruiting
Natal, Brazil
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Status: Recruiting
London, Canada
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Status: Recruiting
Ottawa, Canada
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Status: Recruiting
Toronto, Canada
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Guangzhou, 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: Recruiting
Beijing, China
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Status: Recruiting
Beijing, China
No email / No phone
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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Status: Recruiting
Hangzhou, China
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Status: Recruiting
Hangzhou, China
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Status: Recruiting
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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Status: Recruiting
Kunming, China
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Status: Recruiting
Nanchang, China
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Status: Recruiting
Nanjing, China
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Status: Recruiting
Nanjing, China
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Status: Recruiting
Nanning, China
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Status: Recruiting
Shanghai, China
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Status: Recruiting
Shanghai, China
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Status: Recruiting
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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Status: Recruiting
Tianjin, China
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Status: Recruiting
Wuhan, China
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Status: Recruiting
Wuhan, China
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Status: Recruiting
Xi'an, China
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Status: Recruiting
Yantai, China
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Status: Recruiting
Zhengzhou, China
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Status: Recruiting
Zhengzhou, China
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Status: Recruiting
Ostrava, Czechia
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Status: Recruiting
Olomouc, Czechia
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Status: Recruiting
Saint-Mande, France
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Status: Recruiting
Saint Herblain, France
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Status: Recruiting
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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Status: Recruiting
Marseille, France
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Status: Recruiting
La Tronche, France
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Status: Recruiting
Hellemmes-Lille, France
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Status: Recruiting
Créteil, France
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Status: Recruiting
Bron, France
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Status: Recruiting
Angers, France
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Status: Recruiting
Suresnes, France
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Status: Recruiting
Mainz, Germany
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Status: Recruiting
Berlin, Germany
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Status: Recruiting
Gauting, Germany
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Status: Recruiting
Georgsmarienhütte, Germany
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Status: Recruiting
Heidelberg, Germany
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Status: Recruiting
Oldenburg, Germany
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Status: Recruiting
Reggio Emilia, Italy
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Status: Recruiting
Siena, Italy
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Status: Recruiting
Roma, Italy
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Status: Recruiting
Meldola, Italy
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Status: Recruiting
Modena, Italy
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Status: Recruiting
Monza, Italy
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Status: Recruiting
Palermo, Italy
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Status: Recruiting
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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Status: Recruiting
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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Status: Recruiting
Warsaw, Poland
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Status: Recruiting
Poznań, Poland
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Status: Recruiting
Madrid, Spain
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Status: Recruiting
Málaga, Spain
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Status: Recruiting
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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Status: Recruiting
A Coruña, Spain
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Status: Recruiting
Barcelona, Spain
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Status: Recruiting
Barcelona, Spain
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Status: Recruiting
Barcelona, Spain
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Status: Recruiting
Barcelona, Spain
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Status: Recruiting
Barcelona, Spain
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Status: Recruiting
Girona, Spain
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Status: Recruiting
Jerez De La Frontera, Spain
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Status: Recruiting
Madrid, Spain
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Status: Recruiting
Madrid, Spain
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Status: Recruiting
Madrid, Spain
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Status: Recruiting
Madrid, Spain
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Status: Recruiting
Ankara, Turkey
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Status: Recruiting
Ankara, Turkey
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Status: Recruiting
Konya, Turkey
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Status: Recruiting
Kadıköy, Turkey
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Status: Recruiting
Istanbul, Turkey
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Status: Recruiting
Edirne, Turkey
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Status: Recruiting
Ankara, Turkey
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Status: Recruiting
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