Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07288177

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

Led by Genmab · Updated on 2026-05-12

240

Participants Needed

15

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
  • Participant must have radiological disease progression while on or after receiving the most recent regimen.
  • Participants either may have actionable genetic alterations or no actionable genetic alterations.
  • Participant has measurable disease according to RECIST v1.1.
  • Participant has an Eastern Cooperative Oncology Group Performance Status score of 0 or 1 within 7 days of Cycle 1 Day 1.
Not Eligible

You will not qualify if you...

  • Participant has NSCLC with histology other than adenocarcinoma.
  • Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy, except certain low-risk cancers treated or cured for 3 or more years.
  • Participants with newly identified or known unstable or symptomatic central nervous system metastases or history of carcinomatous meningitis.
  • Participants with history of spinal cord compression from disease.
  • Participants with previous CNS-directed therapy for brain metastases may participate only if lesions are radiologically stable for at least 28 days by repeat imaging.

AI-Screening

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Trial Site Locations

Total: 15 locations

1

Compassionate Cancer Care Center

Fountain Valley, California, United States, 92708

Actively Recruiting

2

Providence Medical Foundation (St. Joseph Heritage Healthcare)

Santa Rosa, California, United States, 95403

Actively Recruiting

3

Nebraska Hematology-Oncology

Lincoln, Nebraska, United States, 68506

Actively Recruiting

4

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

Actively Recruiting

5

ONE Onc: New York Oncology Hematology

Albany, New York, United States, 12206

Actively Recruiting

6

Montefiore Medical Park

The Bronx, New York, United States, 10461

Actively Recruiting

7

Tennessee Oncology - Nashville St. Thomas Midtown Clinic

Nashville, Tennessee, United States, 37203

Actively Recruiting

8

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

9

Shanghai East Hospital

Shanghai, Pudong, China

Actively Recruiting

10

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Actively Recruiting

11

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

Actively Recruiting

12

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Actively Recruiting

13

Japan Community Health Care Organization Chukyo Hospital

Nagoya, Minami Ward, Japan

Actively Recruiting

14

Saitama Medical University International Medical Center

Saitama, Moroyama, Japan

Actively Recruiting

15

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka, Japan

Actively Recruiting

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Research Team

G

Genmab Trial Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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