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Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
Sponsor: Genmab
Summary
This Phase 2 study will be conducted in different countries around the world with up to about 240 participants. The purpose of this study is to evaluate how well Rina-S works against lung cancer. The treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo. The treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
Official title: A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-01-30
Completion Date
2028-11-22
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Rina-S
Intravenous (IV) infusion.
Locations (41)
Compassionate Cancer Care Center
Fountain Valley, California, United States
Providence Medical Foundation (St. Joseph Heritage Healthcare)
Santa Rosa, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Nebraska Hematology-Oncology
Lincoln, Nebraska, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
ONE Onc: New York Oncology Hematology
Albany, New York, United States
Montefiore Medical Park
The Bronx, New York, United States
UNC Health - University of North Carolina
Chapel Hill, North Carolina, United States
Tennessee Oncology - Nashville St. Thomas Midtown Clinic
Nashville, Tennessee, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
St Andrews Medical Centre
Adelaide, Australia
Icon Cancer Centre Hobart
Hobart, Australia
Icon Cancer Care - Townsville
Hyde Park, Australia
St John of God Murdoch Hospital
Murdoch, Australia
GenesisCare North Shore
Saint Leonards, Australia
Shanghai East Hospital
Shanghai, Pudong, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Cochin Hospital
Paris, France
Institut Curie - Centre de Recherche
Paris, France
Lyon Sud Hospital Center
Pierre-Bénite, France
Evangelische Lungenklinik Berlin
Berlin, Germany
Universitaetsklinikum Essen
Essen, Germany
Szent Borbála Hospital
Tatabánya, Hungary
Istituto di Candiolo - IRCCS
Candiolo, Italy
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
Japan Community Health Care Organization Chukyo Hospital
Nagoya, Minami Ward, Japan
Saitama Medical University International Medical Center
Saitama, Moroyama, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, Japan
Kyoto Prefectural University of Medicine
Kyoto, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan
The Netherlands Cancer Institute (NKI)
Amsterdam, Netherlands
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Krakow, Poland
Instytut MSF
Lodz, Poland
MedPolonia
Poznan, Poland
Parc de Salut Mar - Hospital del Mar
Barcelona, Spain
Clinica Universidad de Navarra - Madrid
Madrid, Spain
MD Anderson Cancer Center Madrid
Madrid, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain