NCT07288177RecruitingPhase 2
Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 30 Jan 2026
- Primary completion date
- 22 Nov 2027
- Lead sponsor
- Genmab
- Diseases
- Lung cancer
- NCT number
- NCT07288177
- EU CT number
- 2025-522107-18-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 240
- From 30 Jan 2026 to the primary completion date, 22 Nov 2027
- 123 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Participant has NSCLC with histology other than adenocarcinoma
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (123)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Andrews Medical Centre Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Blacktown Hospital Coordinator of this site? Confirm its status | Blacktown | Australia | Recruiting |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Icon Cancer Centre Hobart Coordinator of this site? Confirm its status | Hobart | Australia | Recruiting |
| Icon Cancer Care - Townsville Coordinator of this site? Confirm its status | Hyde Park | Australia | Recruiting |
| Icon Cancer Centre Townsville ICON Cancer Care - Townsville Coordinator of this site? Confirm its status | Hyde Park | Australia | Recruiting |
| St George Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| St John of God Murdoch Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| GenesisCare North Shore Coordinator of this site? Confirm its status | Saint Leonards | Australia | Recruiting |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| Chu Helora Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Chest Tumor Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Jilin Provincial Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital) Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Hebei North University Coordinator of this site? Confirm its status | Zhangjiakou | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Martha-Maria Krankenhaus Halle-Doelau gGmbH Coordinator of this site? Confirm its status | Halle (saale) | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Instituto Oncologico Dr. Rosell S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Fundacion Rioja Salud Coordinator of this site? Confirm its status | Logrono | Spain | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Quironsalud Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Fondation Hôpital Saint-Joseph Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Clinic Of Pulmonology Semmelweis University Coordinator of this site? Confirm its status | Budapest Viii | Hungary | Recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Recruiting |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Recruiting |
| Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| National Cancer Center - Tsukiji Campus Coordinator of this site? Confirm its status | Chūō | Japan | Recruiting |
| Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Japan Community Health Care Organization Chukyo Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Recruiting |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| NHO Kinki-Chuo Chest Medical Center Coordinator of this site? Confirm its status | Sakai | Japan | Recruiting |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Kanagawa Cardiovascular and Respiratory Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Przychodnia Lekarska Komed Roman Karaszewski Coordinator of this site? Confirm its status | Konin | Poland | Recruiting |
| Instytut MSF Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| National Cheng Kung University Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Chi Mei Medical Center - Liouying Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital NTUH Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| ONE Onc: New York Oncology Hematology Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Emory Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| St. Vincent Frontier Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| UNC Health - University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Baylor Charles A. Sammons Cancer Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Astera Cancer Care Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| Williamette Valley Cancer Institute and Research Center Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Compassionate Cancer Care Center Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Nebraska Hematology-Oncology Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| University of Miami Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Tennessee Oncology - Nashville St. Thomas Midtown Clinic Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Tennessee Oncology Nashville - SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Kaiser Permanente San Diego Mission Road Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Providence Medical Foundation (St. Joseph Heritage Healthcare) Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Montefiore Medical Park Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Providence Oncology & Hematology Care Clinic - Westside Coordinator of this site? Confirm its status | West Haven-Sylvan | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.