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NCT07288177PHASE2Recruiting

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

Genmab

Start Date

1/30/2026

Completion Date

11/22/2028

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Rina-S

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Conditions

Non-small Cell Lung Cancer (NSCLC)

Locations

Compassionate Cancer Care Center

Fountain Valley, California 92708

United States

Providence Medical Foundation (St. Joseph Heritage Healthcare)

Santa Rosa, California 95403

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

Moffitt Cancer Center and Research Institute

Tampa, Florida 33612

United States

Nebraska Hematology-Oncology

Lincoln, Nebraska 68506

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

ONE Onc: New York Oncology Hematology

Albany, New York 12206

United States

Montefiore Medical Park

The Bronx, New York 10461

United States

UNC Health - University of North Carolina

Chapel Hill, North Carolina 27514

United States

Tennessee Oncology - Nashville St. Thomas Midtown Clinic

Nashville, Tennessee 37203

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

St Andrews Medical Centre

Adelaide,

Australia

Icon Cancer Centre Hobart

Hobart,

Australia

Icon Cancer Care - Townsville

Hyde Park,

Australia

St John of God Murdoch Hospital

Murdoch,

Australia

GenesisCare North Shore

Saint Leonards,

Australia

Shanghai East Hospital

Shanghai, Pudong

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin,

China

Cochin Hospital

Paris,

France

Institut Curie - Centre de Recherche

Paris,

France

Lyon Sud Hospital Center

Pierre-Bénite,

France

Evangelische Lungenklinik Berlin

Berlin,

Germany

Universitaetsklinikum Essen

Essen,

Germany

Szent Borbála Hospital

Tatabánya,

Hungary

Istituto di Candiolo - IRCCS

Candiolo,

Italy

Kitasato University Hospital

Sagamihara, Kanagawa

Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa

Japan

Japan Community Health Care Organization Chukyo Hospital

Nagoya, Minami Ward

Japan

Saitama Medical University International Medical Center

Saitama, Moroyama

Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka

Japan

Kyoto Prefectural University of Medicine

Kyoto,

Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo,

Japan

The Netherlands Cancer Institute (NKI)

Amsterdam,

Netherlands

KOMED Roman Karaszewski I Wspolnicy Spolka Jawna

Krakow,

Poland

Instytut MSF

Lodz,

Poland

MedPolonia

Poznan,

Poland

Parc de Salut Mar - Hospital del Mar

Barcelona,

Spain

Clinica Universidad de Navarra - Madrid

Madrid,

Spain

MD Anderson Cancer Center Madrid

Madrid,

Spain

Clinica Universidad de Navarra - Pamplona

Pamplona,

Spain

Hospital Clinico Universitario de Valencia

Valencia,

Spain