Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
Recruiting · NCT07288177 · Interventional (participants receive a specific treatment) · Lead sponsor: Genmab
View the official record on ClinicalTrials.gov →Interventions studied
Rina-S
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
- Participant must have radiological disease progression while on or after receiving the most recent regimen.
- Participants either may have actionable genetic alterations (AGAs) or no AGAs.
- Participant has measurable disease according to RECIST v1.1.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.
- Key
Exclusion criteria
- all study cohorts):
- Participant has NSCLC with histology other than adenocarcinoma
- Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
- Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Where it is running
57 locations listed across 12 US states.
- 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
- Emory Winship Cancer Institute - Atlanta, Georgia, United States
- St. Vincent Frontier Cancer Center - Billings, Montana, 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
- Providence Portland Medical Center - Portland, Oregon, United States
- Providence Oncology & Hematology Care Clinic - Westside - West Haven-Sylvan, Oregon, 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
- The Netherlands Cancer Institute (NKI) - Amsterdam, Netherlands
- Hospital Germans Trias i Pujol - Barcelona, Spain
- Parc de Salut Mar - Hospital del Mar - Barcelona, Spain
- USP Instituto Universitario Dexeus - Barcelona, Spain
- Beijing Chest Tumor Hospital - Beijing, China
- Evangelische Lungenklinik Berlin - Berlin, Germany
- Istituto di Candiolo - IRCCS - Candiolo, Italy
- Universitaetsklinikum Essen - Essen, Germany
- Krankenhaus Martha-Maria Halle-Dölau - Halle, Germany
- Icon Cancer Centre Hobart - Hobart, Australia
- Icon Cancer Care - Townsville - Hyde Park, Australia
- Bács-Kiskun Megyei Kórház - Kecskemét - Kecskemét, Hungary
- KOMED Roman Karaszewski I Wspolnicy Spolka Jawna - Krakow, Poland
- Kyoto Prefectural University of Medicine - Kyoto, Japan
- Chu Helora Hospital La Louvière Site Jolimont - La Louvière, Belgium
- Leids Universitair Medisch Centrum - Leiden, Netherlands
- Instytut MSF - Lodz, Poland
- START Rioja - Logroño, Spain
- Clinica Universidad de Navarra - Madrid - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- MD Anderson Cancer Center Madrid - Madrid, Spain
- St John of God Murdoch Hospital - Murdoch, Australia
- Hospital Quirón Málaga - Málaga, Spain
- Clinica Universidad de Navarra - Pamplona - Pamplona, Spain
- Cochin Hospital - Paris, France
- Groupe Hospitalier Paris Saint-Joseph - Paris, France
- Institut Curie - Centre de Recherche - Paris, France
- Lyon Sud Hospital Center - Pierre-Bénite, France
- MedPolonia - Poznan, Poland
- AZ Delta (Campus Wilgenstraat) - Roeselare, Belgium
- GenesisCare North Shore - Saint Leonards, Australia
- Szent Borbála Hospital - Tatabánya, Hungary
- Tianjin Medical University Cancer Institute and Hospital - Tianjin, China
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Tokyo, Japan
- Hospital Clinico Universitario de Valencia - Valencia, Spain
- 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
- Shanghai East Hospital - Shanghai, Pudong, China