RecruitingPhase 2NCT07288177

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


Sponsor

Genmab

Enrollment

240 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new treatment called Rina-S in people with advanced or metastatic non-small cell lung cancer (NSCLC) of the adenocarcinoma type whose cancer has continued to grow despite previous treatment. **You may be eligible if...** - You have confirmed metastatic or locally advanced lung adenocarcinoma (a specific type of NSCLC) that cannot be treated with surgery or curative radiation - Your cancer has progressed on or after a previous treatment regimen - You have measurable disease on imaging - Your performance status is good (ECOG 0 or 1) - You may or may not have specific genetic mutations in your tumor **You may NOT be eligible if...** - Your lung cancer is a type other than adenocarcinoma - You have had another active cancer before enrollment - Your organ function does not meet the required thresholds - You have active or uncontrolled brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRina-S

Intravenous (IV) infusion.


Locations(8)

Providence Medical Foundation (St. Joseph Heritage Healthcare)

Santa Rosa, California, United States

Nebraska Hematology-Oncology

Lincoln, Nebraska, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

ONE Onc: New York Oncology Hematology

Albany, New York, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Japan Community Health Care Organization Chukyo Hospital

Nagoya, Minami Ward, Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07288177


Related Trials