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Clinical Trials in the USA / NCT07288177
Recruiting Phase 2

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

NCT07288177 · tracked via the Priya Life Science USA tracker
Sponsor
Genmab
Phase
Phase 2
Started
2026-01-30
Last updated
2026-08-26

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Rina-S

Rina-S: Intravenous (IV) infusion.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * 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 (AGAs) or no AGAs. * Participant has measurable disease according to RECIST v1.1. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1. Key Exclusion Criteria (all study cohorts): * 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. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years. * Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Compassionate Cancer Care Center Fountain Valley California Recruiting
Kaiser Permanente San Diego Mission Road San Diego California Recruiting
Providence Medical Foundation (St. Joseph Heritage Healthcare) Santa Rosa California Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
Moffitt Cancer Center and Research Institute Tampa Florida Recruiting
Emory Winship Cancer Institute Atlanta Georgia Recruiting
St. Vincent Frontier Cancer Center Billings Montana Recruiting
Nebraska Hematology-Oncology Lincoln Nebraska Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
ONE Onc: New York Oncology Hematology Albany New York Recruiting
Montefiore Medical Park The Bronx New York Recruiting
UNC Health - University of North Carolina Chapel Hill North Carolina Recruiting
Williamette Valley Cancer Institute and Research Center Eugene Oregon Recruiting
Providence Portland Medical Center Portland Oregon Recruiting
Providence Oncology & Hematology Care Clinic - Westside West Haven-Sylvan Oregon Recruiting
Tennessee Oncology - Nashville St. Thomas Midtown Clinic Nashville Tennessee Recruiting
Tennessee Oncology Nashville - SCRI Oncology Partners Nashville Tennessee Recruiting
Baylor Charles A. Sammons Cancer Center Dallas Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
St Andrews Medical Centre Adelaide Australia Recruiting
Chris O'Brien Lifehouse Camperdown Australia Recruiting
Icon Cancer Centre Hobart Hobart Australia Recruiting
Icon Cancer Care - Townsville Hyde Park Australia Recruiting
St John of God Murdoch Hospital Murdoch Australia Recruiting
GenesisCare North Shore Saint Leonards Australia Recruiting
Chu Helora Hospital La Louvière Site Jolimont La Louvière Belgium Recruiting
UZ Leuven - Gasthuisberg Campus Leuven Belgium Recruiting
AZ Delta (Campus Wilgenstraat) Roeselare Belgium Recruiting
Shanghai East Hospital Shanghai Pudong Recruiting
Beijing Chest Tumor Hospital Beijing China Recruiting
Tianjin Medical University Cancer Institute and Hospital Tianjin China Recruiting
The First Affiliated Hospital of Hebei North University Zhangjiakou China Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord Marseille France Recruiting
Cochin Hospital Paris France Recruiting
Groupe Hospitalier Paris Saint-Joseph Paris France Recruiting
Institut Curie - Centre de Recherche Paris France Recruiting
Lyon Sud Hospital Center Pierre-Bénite France Recruiting
Evangelische Lungenklinik Berlin Berlin Germany Recruiting
Universitaetsklinikum Essen Essen Germany Recruiting

+ 34 more sites — see the full list on the official registry below.

More Genmab trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07288177 on ClinicalTrials.gov ↗ ← All trials in the USA