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

Study acronym: RAINFOL-05
StatusRecruiting
PhasePhase 2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 74 → 91 locations Eligibility criteria expanded, about 8 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 8 words
  2. Minor Trial sites expanded: 57 → 74 locationsv15
  3. Minor Trial sites expanded: 41 → 57 locationsv14
  4. Minor Trial sites expanded: 22 → 41 locationsv13
  5. Minor Trial sites expanded: 15 → 22 locationsv12
  6. Minor Study sites: 13 to 15v11
  7. Minor Trial sites expanded: 8 → 13 locationsv10
  8. Minor Trial sites expanded: 2 → 8 locationsv9
  9. Minor 3 versions Re-verified since Feb 3, 2026, no change to tracked fieldsv6-v8
  10. Minor Start date changed from estimate of Feb 16, 2026 to Jan 30, 2026v5
  11. Minor Study sites: 1 to 2 Start date: Jan 31, 2026 to Feb 16, 2026v4 Show 1 more changeShow less
    • Start date: Jan 31, 2026 to Feb 16, 2026
  12. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  13. Minor Re-verified, no change to tracked fieldsv2
  14. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07288177
Lead Sponsor Genmab
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov