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Taking people in BelgiumPhase 2

Tests Rina-S in adults with advanced non-small cell lung cancer

Tests Rina-S alone in adults with lung cancer that is advanced or has spread.

Key facts

Who runs it
Genmab
Where
Anderlecht, Edegem, Hasselt, La Louvière, Leuven, Liège, and Roeselare, BelgiumSee the 7 sitesAlso in 13 other countries, 116 sites
Trial code
Registry title
Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
People taking part
240 people, planned
Started
30 Jan 2026
Expected to end
22 Nov 2028
Type of study
Interventional
Treatments tested
  • Rina-S
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with lung cancer of the adenocarcinoma type that has spread or grown locally. The cancer must have progressed during or after the most recent treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Metastatic or locally advanced non-small cell lung cancer of adenocarcinoma type, which cannot be treated with surgery or radiotherapy meant to remove all of the disease. The disease must be measurable (RECIST v1.1) and must have progressed on or after the most recent treatment. ECOG performance status 0 or 1.
Earlier treatment
Imaging must show the disease progressed while on or after the most recent treatment regimen.
Biomarker or test result
People with or without actionable genetic alterations can join.

Main reasons for not taking part

  • Lung cancer of a type other than adenocarcinoma
  • Another past or current cancer, or leftover disease from an earlier cancer, with limited exceptions
  • Unstable or symptomatic cancer spread to the brain or spinal cord area (CNS)
  • History of cancer spread to the membranes around the brain (leptomeningeal disease)
  • History of spinal cord compression from the disease

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • Participant has NSCLC with histology other than adenocarcinoma

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • Can you look after yourself and are you up and about most of the day?
  • Has your cancer spread to the brain?
  • Has your cancer spread to the lining around the brain or spinal cord?

Where in Belgium

Also in 13 other countries, 116 sites

  • Institut Jules BordetAnderlecht, BelgiumTaking people
  • Universitair Ziekenhuis AntwerpenEdegem, BelgiumTaking people
  • JESSA ZiekenhuisHasselt, BelgiumTaking people
  • Chu HeloraLa Louvière, BelgiumTaking people
  • UZ LeuvenLeuven, BelgiumTaking people
  • Centre Hospitalier Universitaire de LiègeLiège, BelgiumTaking people
  • Algemeen Ziekenhuis DeltaRoeselare, BelgiumTaking people

About the trial

What the trial wants to find out

This Phase 2 study will be conducted in different countries around the world with up to about 240 participants.

Read full original descriptionShow less

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.

The group in the trial

  • Rina-STreatment being tested

    Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
Plain-language title
Tests Rina-S in adults with advanced non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07288177, who can take part
Record updated
3 November 2026