RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Genmab • ClinicalTrials.gov ID: NCT07288177

Registry updated: 2026-10-06

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Description

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.

Interventions

Rina-S (Drug)
Intravenous (IV) infusion.

Eligibility criteria

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Locations

Compassionate Cancer Care Center — Fountain Valley, California, United States
City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
Kaiser Permanente San Diego Mission Road — San Diego, California, United States
Providence Medical Foundation (St. Joseph Heritage Healthcare) — Santa Rosa, California, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
University of Miami Hospital — Miami, Florida, United States
Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Emory Winship Cancer Institute — Atlanta, Georgia, United States
St. Vincent Frontier Cancer Center — Billings, Montana, United States
Nebraska Hematology-Oncology — Lincoln, Nebraska, United States
Astera Cancer Care — East Brunswick, New Jersey, United States
ONE Onc: New York Oncology Hematology — Albany, New York, United States
Montefiore Medical Park — The Bronx, New York, United States
UNC Health - University of North Carolina — Chapel Hill, North Carolina, United States
Williamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
Providence Portland Medical Center — Portland, Oregon, United States
Providence Oncology & Hematology Care Clinic - Westside — West Haven-Sylvan, Oregon, United States
Tennessee Oncology - Nashville St. Thomas Midtown Clinic — Nashville, Tennessee, United States
Tennessee Oncology Nashville - SCRI Oncology Partners — Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
Virginia Cancer Specialists — Fairfax, Virginia, 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

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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