Non-small Cell Lung Cancer (NSCLC)Phase 2RAINFOL-05NCT07288177
Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
A Phase 2 study testing Rina-S in people with Non-small Cell Lung Cancer (NSCLC), run by Genmab at 91 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Rina-S
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 91 sitesin 13 countries
- Study dates
- 30 Jan 2026to 22 Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
91 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
91 sites in 13 countries
United States21 sites, 21 recruiting
- Recruiting
ONE Onc: New York Oncology Hematology
Albany, New York, 12206
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
- Recruiting
UNC Health - University of North Carolina
Chapel Hill, North Carolina, 27514
- Recruiting
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
- Recruiting
Williamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Compassionate Cancer Care Center
Fountain Valley, California, 92708
- Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
Nebraska Hematology-Oncology
Lincoln, Nebraska, 68506
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
- Recruiting
Tennessee Oncology - Nashville St. Thomas Midtown Clinic
Nashville, Tennessee, 37203
- Recruiting
Tennessee Oncology Nashville - SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
- Recruiting
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108
- Recruiting
Providence Medical Foundation (St. Joseph Heritage Healthcare)
Santa Rosa, California, 95403
- Recruiting
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
- Recruiting
Montefiore Medical Park
The Bronx, New York, 10461
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Recruiting
Providence Oncology & Hematology Care Clinic - Westside
West Haven-Sylvan, Oregon, 97225
Spain15 sites, 15 recruiting
- Recruiting
Hospital Teresa Herrera
A Coruña
- Recruiting
Hospital Germans Trias i Pujol
Barcelona
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona
- Recruiting
USP Instituto Universitario Dexeus
Barcelona
- Recruiting
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria
- Recruiting
START Rioja
Logroño
- Recruiting
Clinica Universidad de Navarra - Madrid
Madrid
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid
- Recruiting
MD Anderson Cancer Center Madrid
Madrid
- Recruiting
Hospital Quirón Málaga
Málaga
- Recruiting
Clinica Universidad de Navarra - Pamplona
Pamplona
- Recruiting
Fundación IVO. Instituto Valenciano de Oncología
Valencia
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia
China8 sites, 8 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
- Recruiting
Beijing Chest Tumor Hospital
Beijing
- Recruiting
Jilin Provincial Cancer Hospital
Changchun
- Recruiting
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
Nanjing
- Recruiting
Shanghai East Hospital
Shanghai, Pudong
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
- Recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou
- Recruiting
Henan Cancer Hospital
Zhengzhou
Japan8 sites, 8 recruiting
- Recruiting
National Cancer Center - Tsukiji Campus
Chūō
- Recruiting
Kyoto Prefectural University of Medicine
Kyoto, Kyoto
- Recruiting
Japan Community Health Care Organization Chukyo Hospital
Nagoya, Minami Ward
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa
- Recruiting
Saitama Medical University International Medical Center
Saitama, Moroyama
- Recruiting
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka
- Recruiting
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo
- Recruiting
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa
Australia7 sites, 7 recruiting
- Recruiting
St Andrews Medical Centre
Adelaide
- Recruiting
Chris O'Brien Lifehouse
Camperdown
- Recruiting
Icon Cancer Centre Hobart
Hobart
- Recruiting
Icon Cancer Care - Townsville
Hyde Park
- Recruiting
Icon Cancer Centre Townsville ICON Cancer Care - Townsville
Hyde Park
- Recruiting
St John of God Murdoch Hospital
Murdoch
- Recruiting
GenesisCare North Shore
Saint Leonards
Belgium5 sites, 5 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem
- Recruiting
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt
- Recruiting
Chu Helora Hospital La Louvière Site Jolimont
La Louvière
- Recruiting
UZ Leuven - Gasthuisberg Campus
Leuven
- Recruiting
AZ Delta (Campus Wilgenstraat)
Roeselare
France5 sites, 5 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille
- Recruiting
Cochin Hospital
Paris
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris
- Recruiting
Institut Curie - Centre de Recherche
Paris
- Recruiting
Lyon Sud Hospital Center
Pierre-Bénite
Italy5 sites, 5 recruiting
- Recruiting
Istituto di Candiolo - IRCCS
Candiolo
- Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola
- Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano
- Recruiting
Ospedale Santa Maria delle Croci
Ravenna
- Recruiting
Policlinico Agostino Gemelli
Roma
Taiwan5 sites, 5 recruiting
- Recruiting
Changhua Christian Hospital
Changhua
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
- Recruiting
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City
- Recruiting
Chi Mei Medical Center - Liouying
Tainan
- Recruiting
National Cheng Kung University
Tainan
Germany4 sites, 4 recruiting
- Recruiting
Evangelische Lungenklinik Berlin
Berlin
- Recruiting
Universitaetsklinikum Essen
Essen
- Recruiting
Krankenhaus Martha-Maria Halle-Dölau
Halle
- Recruiting
Thoraxklinik-Heidelberg
Heidelberg
Poland4 sites, 4 recruiting
- Recruiting
Gdański Uniwersytet Medyczny
Gdansk
- Recruiting
KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
Krakow
- Recruiting
Instytut MSF
Lodz
- Recruiting
MedPolonia
Poznan
Hungary2 sites, 2 recruiting
- Recruiting
Bács-Kiskun Megyei Kórház - Kecskemét
Kecskemét
- Recruiting
Szent Borbála Hospital
Tatabánya
Netherlands2 sites, 2 recruiting
- Recruiting
The Netherlands Cancer Institute (NKI)
Amsterdam
- Recruiting
Leids Universitair Medisch Centrum
Leiden
About this study
Official title: A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
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.
Read more
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Rina-S
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rina-SDrug
Also called Rinatabart Sesutecan, PRO1184, GEN1184
Intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Rina-S | Experimental | Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy. Receives: Drug: Rina-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator
Measured: Approximately 3 years
Secondary outcomes (8)
Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator
Measured: Approximately 4 years
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator
Measured: Approximately 4 years
Progression-free Survival (PFS)
Measured: Approximately 4 years
Overall Survival (OS)
Measured: Approximately 4 years
Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes
Measured: Approximately 12 months
Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes
Measured: Approximately 12 months
Number of Participants with Antidrug Antibodies (ADAs)
Measured: Approximately 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start30 Jan 2026
- Primary completion22 Nov 2027 (estimated)
- Study completion22 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288177
- Sponsor's protocol ID
- GCT1184-05
- Other IDs
- 2025-522107-18-00, jRCT2041250176, CTR20260819, 2025
- Acronym
- RAINFOL-05
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No