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


Active: Yes
Cancer Type: Lung Cancer NCT ID: NCT07288177
Trial Phases: Phase II Protocol IDs: GCT1184-05 (primary)
NCI-2026-02378
2025
2025-522107-18-00
CTR20260819
jRCT2041250176
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Genmab
NCI Full Details: http://clinicaltrials.gov/show/NCT07288177

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.