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 study about?

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.

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 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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
MD Anderson Cancer Center Madrid Spain
Instytut Msf Sp. z o.o. Lodz Poland
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Hospital Quironsalud Malaga Malaga Spain
Med Polonia Sp. z o.o. Poznan Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Jessa Ziekenhuis Hasselt Belgium
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
CHU Helora La Louviere Belgium
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Clinic De Barcelona Barcelona Spain
Istituto Oncologico Veneto Padua Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Justus-Liebig-Universitaet Giessen Giessen Germany
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Radboud universitair medisch centrum Stichting Nijmegen The Netherlands
Uohfnrngxedsrezothshx Eosmq Apa Essen Germany
Lxtrp Uyfrnfylrqte Mnhamwl Cwelyhk (yaogp Leiden The Netherlands
Iirifrrus Ofyjuyyjei Dnm Rgfcms Spwg Barcelona Spain
Budaztgrhqc Vizvlodqt Omhsvfjeyawp Kecskemet Hungary
Ibqsgtti Rbdwaxaxc Prq Lb Sulove Dbp Timxxd Deou Aaseymn Imip Sjuvdr Meldola Italy
Astpbksjrk Pkwgopok Htraxwxh Dr Mywbsqzub Marseille France
Nppftzpg Ipjjyrjq Omnlrslqx Ifv Mwreg Sqwcifribhyzfggdzuilvvjvhhke Imkfaoqq Bahhqpmb Cracow Poland
Uljczghzlieiaw Cvhtwzc Kinhyxyaa Gdansk Poland
Uniqqvaedq Oc Awrrqxf Edegem Belgium
Gizovz Hwvbyclgcjm Udiniymugpiff Pwbdx Pjwwqvvptvg Eo Nkgzagsynxlr Paris France
Ihpvmsmp Cotsnh Dhctqybhowqzphlif L'hospitalet De Llobregat Spain
Pttfhhlgexg Lssqibxt &nmgjvlzrlyxzltdfzmw Rgedz Kqbkxconhrr Konin Poland
Hozvldla Uettfbjilrjkg dq A Cyqwim A Coruna Galicia Spain
Hmulolhm Vkfx dctyisdd Barcelona Spain
Arqmadm Owzehqrxjca Uuivgewfawsag Pyjzu Parma Italy
Ieorsc Iiifxyyv Fnxuyditkshbr Oufwdteabyn Rome Italy
Uyuzgruqof Hmitnyeu Ckbzqfe Cologne Germany
Exwmkqt Udtnlikflpkt Munztjj Cujkjdq Rhcndndtn (oyktkfv Mix Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
28.05.2026
France France
Recruiting
28.05.2026
Germany Germany
Not yet recruiting
28.05.2026
Hungary Hungary
Recruiting
28.05.2026
Italy Italy
Recruiting
28.05.2026
Poland Poland
Recruiting
28.05.2026
Spain Spain
Recruiting
28.05.2026
The Netherlands The Netherlands
Recruiting
28.05.2026

Trial locations

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.

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 ID:
2025-522107-18-00
Protocol code:
GCT1184-05
Trial Phase:
Therapeutic exploratory (Phase II)

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