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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

Interested in This Trial?

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Conditions

Non-small Cell Lung Cancer (NSCLC)

Locations

Compassionate Cancer Care Center

Fountain Valley, California 92708

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Kaiser Permanente San Diego Mission Road

San Diego, California 92108

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

University of Miami Hospital

Miami, Florida 33136

United States

Moffitt Cancer Center and Research Institute

Tampa, Florida 33612

United States

Emory Winship Cancer Institute

Atlanta, Georgia 30322

United States

St. Vincent Frontier Cancer Center

Billings, Montana 59102

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

Williamette Valley Cancer Institute and Research Center

Eugene, Oregon 97401

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence Oncology & Hematology Care Clinic - Westside

West Haven-Sylvan, Oregon 97225

United States

Tennessee Oncology - Nashville St. Thomas Midtown Clinic

Nashville, Tennessee 37203

United States

Tennessee Oncology Nashville - SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

St Andrews Medical Centre

Adelaide,

Australia

Chris O'Brien Lifehouse

Camperdown,

Australia

Icon Cancer Centre Hobart

Hobart,

Australia

Icon Cancer Care - Townsville

Hyde Park,

Australia

Icon Cancer Centre Townsville ICON Cancer Care - Townsville

Hyde Park,

Australia

St John of God Murdoch Hospital

Murdoch,

Australia

GenesisCare North Shore

Saint Leonards,

Australia

Universitair Ziekenhuis Antwerpen

Edegem,

Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt,

Belgium

Chu Helora Hospital La Louvière Site Jolimont

La Louvière,

Belgium

UZ Leuven - Gasthuisberg Campus

Leuven,

Belgium

AZ Delta (Campus Wilgenstraat)

Roeselare,

Belgium

Shanghai East Hospital

Shanghai, Pudong

China

Beijing Cancer Hospital

Beijing,

China

Beijing Chest Tumor Hospital

Beijing,

China

Jilin Provincial Cancer Hospital

Changchun,

China

Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)

Nanjing,

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin,

China

The First Affiliated Hospital of Hebei North University

Zhangjiakou,

China

Henan Cancer Hospital

Zhengzhou,

China

Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Marseille,

France

Cochin Hospital

Paris,

France

Groupe Hospitalier Paris Saint-Joseph

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

Krankenhaus Martha-Maria Halle-Dölau

Halle,

Germany

Thoraxklinik-Heidelberg

Heidelberg,

Germany

Bács-Kiskun Megyei Kórház - Kecskemét

Kecskemét,

Hungary

Szent Borbála Hospital

Tatabánya,

Hungary

Istituto di Candiolo - IRCCS

Candiolo,

Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola,

Italy

Azienda Ospedaliero Universitaria San Luigi Gonzaga

Orbassano,

Italy

Ospedale Santa Maria delle Croci

Ravenna,

Italy

Policlinico Agostino Gemelli

Roma,

Italy

Kitasato University Hospital

Sagamihara, Kanagawa

Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa

Japan

Kyoto Prefectural University of Medicine

Kyoto, Kyoto

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

National Cancer Center - Tsukiji Campus

Chūō,

Japan

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo,

Japan

The Netherlands Cancer Institute (NKI)

Amsterdam,

Netherlands

Leids Universitair Medisch Centrum

Leiden,

Netherlands

Gdański Uniwersytet Medyczny

Gdansk,

Poland

KOMED Roman Karaszewski I Wspolnicy Spolka Jawna

Krakow,

Poland

Instytut MSF

Lodz,

Poland

MedPolonia

Poznan,

Poland

Hospital Teresa Herrera

A Coruña,

Spain

Hospital Germans Trias i Pujol

Barcelona,

Spain

Parc de Salut Mar - Hospital del Mar

Barcelona,

Spain

USP Instituto Universitario Dexeus

Barcelona,

Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria,

Spain

START Rioja

Logroño,

Spain

Clinica Universidad de Navarra - Madrid

Madrid,

Spain

Hospital General Universitario Gregorio Marañón

Madrid,

Spain

Hospital Universitario 12 de Octubre

Madrid,

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid,

Spain

MD Anderson Cancer Center Madrid

Madrid,

Spain

Hospital Quirón Málaga

Málaga,

Spain

Clinica Universidad de Navarra - Pamplona

Pamplona,

Spain

Fundación IVO. Instituto Valenciano de Oncología

Valencia,

Spain

Hospital Clinico Universitario de Valencia

Valencia,

Spain

Changhua Christian Hospital

Changhua,

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City,

Taiwan

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City,

Taiwan

Chi Mei Medical Center - Liouying

Tainan,

Taiwan

National Cheng Kung University

Tainan,

Taiwan