Actively Recruiting
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
Eligibility Criteria
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.
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
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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