NCT07288177

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

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), with or without select genomic aberrations.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Rina-S	Intravenous (IV) infusion.

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-11-22
• Completion: 2028-11-22
• First posted: 2025-12-17
• Last updated: 2026-04-08

Locations

8 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study