Clinical Trial

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer

Study acronym: RAINFOL-05
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 41 -> 57 locations 2026-08-05
notable Trial sites expanded: 22 -> 41 locations 2026-07-08
notable Trial sites expanded: 15 -> 22 locations 2026-06-03
notable Trial sites expanded: 8 -> 13 locations 2026-05-06
notable Trial sites expanded: 2 -> 8 locations 2026-04-09
Trial Details
NCT Number NCT07288177
Lead Sponsor Genmab
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 240 participants
Start Date 2026-01-30
Primary Completion 2027-11-22 (estimated)
Study Completion 2028-11-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-04