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Phase 2 Study of Rinatabart Sesutecan with PEGFILGRASTIM in Adults with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Non-Small Cell Lung Cancer is a type of lung cancer that starts in the cells lining the airways and can spread to other parts of the body. When the disease is described as locally advanced, it means the tumor has grown beyond the lung but has not yet widely spread, while metastatic indicates that cancer cells have reached distant organs.

The investigational medication being studied is Rinatabart Sesutecan (Rina‑S), which is given through an intravenous infusion, a process where the medicine is delivered directly into a vein using a small needle. The purpose of the study is to assess the anti‑tumor activity of this drug when used alone. The medication is administered in a series of treatment cycles, and participants are monitored regularly for any changes in tumor size, side effects, and overall health.

During the study, tumor measurements are evaluated using the RECIST criteria, a set of simple rules that help doctors decide whether the cancer is shrinking, staying the same, or growing. Participants have scheduled visits for blood tests, imaging scans, and safety checks, allowing researchers to observe how the drug works over time and to record any adverse events that may occur.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study you will sign a consent form that explains the purpose of the trial and your involvement.

  2. Step 2

    Baseline assessments

    Initial tests are performed to record your health status, including imaging of the lung, blood tests, and other examinations needed to confirm eligibility.

  3. Step 3

    First infusion of <b>rinatabart sesutecan</b>

    The study drug is given by intravenous infusion, which means it is delivered directly into a vein over a period of time.

    The specific dose is measured in mg/m2 (milligrams per square meter of body surface) as defined by the study protocol; the exact amount is determined by the study team.

  4. Step 4

    Ongoing treatment cycles

    Additional infusions of rinatabart sesutecan are administered according to the schedule set by the protocol.

    Treatment continues until the study ends, the disease progresses, or an unacceptable side effect occurs.

  5. Step 5

    Tumor response evaluation

    The size of the tumor is measured using the RECIST v1.1 criteria (a standardized way to assess tumor change).

    The primary outcome, called objective response rate, is evaluated over an approximate period of three years.

  6. Step 6

    Secondary efficacy assessments

    Additional measurements include duration of response, disease control rate, progression‑free survival, and overall survival.

    These are monitored for about four years from the start of treatment.

  7. Step 7

    Pharmacokinetic and immunogenicity testing

    Blood samples are taken to determine the highest concentration of the drug in the blood (Cmax) and the time it takes to reach that level (Tmax).

    Tests for antidrug antibodies (ADAs) are also performed.

    These assessments are conducted over an approximate period of twelve months.

  8. Step 8

    Safety monitoring

    Throughout the trial you are monitored for any treatment‑emergent adverse events (side effects that appear after receiving the drug).

    The collection of safety information continues for about four years.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of non‑small cell lung cancer that has spread (metastatic) or cannot be cured with surgery or radiation.
  • The lung cancer must be the adenocarcinoma type, which is a common form of non‑small cell lung cancer.
  • The disease must have gotten worse on imaging scans while the patient was on, or after, their most recent treatment (called radiological disease progression).
  • The patient may either have or not have actionable genetic alterations—specific genetic changes that can sometimes be targeted with special medicines.
  • The cancer must be measurable on scans according to standard rules called RECIST version 1.1 (a way doctors define whether a tumor can be measured).
  • The patient must have an ECOG Performance Status score of 0 or 1 within 7 days before the first treatment day (a score of 0 means fully active, and 1 means they have some symptoms but can still do most daily activities).
  • Both men and women are allowed to join the study.
  • Adults (generally age 18 and older) are eligible to participate.

Who cannot join the trial?

3 criteria

  • Has lung cancer that is not the specific type called adenocarcinoma (the study only includes adenocarcinoma).
  • Has another cancer (past or present) that is not the lung cancer being studied, unless the other cancer is a very low‑risk type (for example, early‑stage cervical cancer, skin cancer that has not spread, early bladder cancer, ductal carcinoma in situ, or any cancer that has been cured for at least three years).
  • Has newly identified or existing brain tumors that are worsening or causing symptoms, a history of cancer spread to the lining of the brain and spinal cord (called leptomeningeal disease), or has had pressure on the spinal cord from disease. Even if brain lesions were treated with radiotherapy or surgery, the patient may only join if those lesions have been stable (no growth) on repeat imaging for at least 28 days.
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Investigated drugs

  • PEGFILGRASTIM

    is a medication that is given as an injection under the skin. In this study it is used as a background treatment to help support the body’s normal blood cell production, especially white blood cells, which can be affected by cancer therapies. By keeping the blood cells at healthier levels, it may reduce the risk of infections and other complications during the trial.

  • Rinatabart Sesutecan

    (also called Rina‑S) is the experimental drug being tested in this trial. It is given through a vein as an infusion. The purpose of Rina‑S is to try to shrink or stop the growth of non‑small cell lung cancer tumors. The study is looking at how well this new therapy works on its own to fight the cancer.

What is already known about the treatment

  • PEGFILGRASTIM

    PEGFILGRASTIM is administered as a subcutaneous injection that you give under the skin. It is an approved drug that appears in many medical references and is widely used in practice. The main use of this medication is to treat multiple sclerosis by calming an over‑active immune system. It works by imitating a natural protein that reduces harmful immune activity and is classified as an immunomodulator.

  • Rinatabart Sesutecan

    Rinatabart Sesutecan is given by intravenous infusion, meaning the medicine is slowly poured into a vein. It is still experimental and currently only described in clinical trial publications. The drug is being studied as a treatment for locally advanced or metastatic non‑small cell lung cancer. Its likely action is to block signals that tell cancer cells to grow, and it is classified as an investigational anticancer agent.

Investigated diseases

Locally advanced or metastatic non‑small cell lung cancer - This disease is a type of lung cancer that starts in the cells lining the airways and forms a solid tumor. In the locally advanced stage, the tumor has grown beyond its original location and may involve nearby structures such as lymph nodes or chest wall. When it becomes metastatic, cancer cells break away and travel through the bloodstream or lymph system to distant organs like the brain, bones, or liver. The tumor typically enlarges gradually, and its spread can lead to new areas of growth in other parts of the body. As the disease progresses, the number and size of tumors can increase over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522107-18-00Protocol codeGCT1184-05Estimated enrolment205 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).