Tests Rina-S in adults with advanced non-small cell lung cancer
Tests Rina-S alone in adults with lung cancer that is advanced or has spread.
Plain-language title generated from the registry record
Registry title: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
Key facts
- Where
- Chūō, Kyoto, Nagoya, Sagamihara, Saitama, Sakai, Tokyo, and Yokohama, JapanSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Can you look after yourself and are you up and about most of the day?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT07288177, who can take part
Where in Japan
- National Cancer Center - Tsukiji CampusChūō, JapanTaking people
- Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- Japan Community Health Care Organization Chukyo HospitalNagoya, JapanTaking people
- Kitasato University HospitalSagamihara, JapanTaking people
- Saitama Medical University International Medical CenterSaitama, JapanTaking people
- NHO Kinki-Chuo Chest Medical CenterSakai, JapanTaking people
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalTokyo, JapanTaking people
- Kanagawa Cardiovascular and Respiratory CenterYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genmab
- Trial code
- NCT07288177EU 2025-522107-18-00
- Record updated
- 3 November 2026
- Original description
This Phase 2 study will be conducted in different countries around the world with up to about 240 participants.Read full original descriptionShow less
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
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.
Inclusion: 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.
Exclusion: 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; Participant has NSCLC with histology other than adenocarcinoma.