Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
RAINFOL-05
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
5 other identifiers
interventional
240
13 countries
74
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2026
Typical duration for phase_2
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2025
CompletedFirst Posted
Study publicly available on registry
December 17, 2025
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 22, 2028
August 26, 2026
August 1, 2026
1.8 years
December 15, 2025
August 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator
Approximately 3 years
Secondary Outcomes (8)
Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator
Approximately 4 years
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator
Approximately 4 years
Progression-free Survival (PFS)
Approximately 4 years
Overall Survival (OS)
Approximately 4 years
Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes
Approximately 12 months
- +3 more secondary outcomes
Study Arms (1)
Rina-S
EXPERIMENTALMultiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participant has NSCLC with histology other than adenocarcinoma
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
Study Sites (74)
Compassionate Cancer Care Center
Fountain Valley, California, 92708, 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
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
St John of God Murdoch Hospital
Murdoch, Australia
GenesisCare North Shore
Saint Leonards, Australia
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 Chest Tumor Hospital
Beijing, 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
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
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
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 Germans Trias i Pujol
Barcelona, Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, Spain
USP Instituto Universitario Dexeus
Barcelona, Spain
START Rioja
Logroño, Spain
Clinica Universidad de Navarra - Madrid
Madrid, Spain
Hospital Universitario 12 de Octubre
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Official
Genmab
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Cohorts A and B will be randomized by dose. Randomization will not be used for Cohorts C, D, or E.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2025
First Posted
December 17, 2025
Study Start
January 30, 2026
Primary Completion (Estimated)
November 22, 2027
Study Completion (Estimated)
November 22, 2028
Last Updated
August 26, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share