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

2 1 1 1

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
Semmelweis University Budapest Hungary
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
CHU Helora La Louviere Belgium
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Izvvstdw Jsdbs Brxonp Anderlecht Belgium
Hbjthypf Vzgw dcrbpfmu Barcelona Spain
Huqdojjo Uegejsepfbcgd dl A Cpffaw A Coruna Galicia Spain
Uzkhnexquy Hyjhhexp Cmtarcn Cologne Germany
Iicqcdhy Rjkvelxsg Ppa Ls Shmnda Dvq Tapkrk Dkrr Apfeiop Igys Svodlg Meldola Italy
Adwlrbrbke Pispuzcx Hlsgfgrn Ds Mqhsicrjz Marseille France
Hgzxmmrc Cbmlzy Dm Bxqachccg Barcelona Spain
Enohzua Umhbwlechmit Mmchsas Cdnixxg Rxqtvzqzp (tkoojnj Mwy Rotterdam The Netherlands
Hbdzcleo Ukkpcorgeadri Fqkiwzzvv Jpsiebq Dsir Madrid Spain
Hosiehom Csxrkpg Sns Cdxkme Madrid Spain
Jbqxi Zszhhqrvqn Hasselt Belgium
Uhdbkdnzmvjujwmhpsoon Hcbqrykxoh Aqa Heidelberg Germany
Jcwvbxandqmsoqpsmwqqlrytwe Ghnivax Giessen Germany
Tvxvvygtmgfg Hdfyqdlwvd grlml Heidelberg Germany
Uqjdublzhlcokt Cysjudk Kqgffrstk Gdansk Poland
Uzyoupuzcp Ok Afhspml Edegem Belgium
Uyjyimzumegfloehxvlpy Edeza Alk Essen Germany
Ixydmm Iykjhoft Ffohrjfoubypt Oslgnnhdrqu Rome Italy
Cphlpb hxryictegxf uadevgsbklakd db Lpwfl Liege Belgium
Csgdpt Hetqtlqzpup Lnfu Sra Pierre Benite France
Hqkrdkga Unhscjpzuhwsk 1c Dr Oxnmxex Madrid Spain
Ihlwmuin Ceanor Dcgtrjvhcgaqcjqam L'hospitalet De Llobregat Spain
Aiutgrgk Zlcnjiprjx Dxihz Roeselare Belgium
Fiqndbgmt Ijftojgll Vpsnbvwybc Du Obkctckhs Valencia Spain
Izaqbazy Okzssjvyie Vqnjjv Padua Italy
Bfryiywmcvt Vlmmlqddd Ollivysmzrgk Kecskemet Hungary
Mpy Pynkitd Scv z ofer Poznan Poland
Pxbcrcmkvbo Lpefbafu &zzoqhpgmgbmkuyfiqzr Rydoh Kkxvegfrmbj Konin Poland
Ahxddue Omhwiclvglzsedjpuhinjfpxi Smv Lrvsg Gasdgmo Orbassano Italy
Uqpudngodfsvrfdqv Cxsino Biohijdjum Df Rknf Rome Italy
Ihplyeav Dg Cvkpnmzs Fuicricyns Djh Pphcykcj Pom Lldqjrxnor Inmuf Candiolo Italy
Nizoauny Ixcajzhx Odbubeqxz Itj Mtdrw Sifzrygqqrjxdboilkydcbkotmpm Idbcmlwa Bmtzimuj Cracow Poland
Awewxvx Umafl Smeskstkv Lomxux Dplki Rckajai Faenza Italy
Aafhrry Ostqgyewxns Uekotpisadnnp Pzago Parma Italy
Nesnmysswbo Cchctu Iaigiqzbp Amsterdam The Netherlands
Gdsmgh Hrjglcqakgj Uxsbdebgbgnrc Pxjyt Pvawqmslyir Es Nbahvwluttjw Paris France
Lmcsz Uzocbvmidhmp Mrguwhg Cbtgxsw (naocf Leiden The Netherlands
Ibdfwcuyx Oydwsszocu Dqh Rtbmvd Shrd Barcelona Spain
Kcjvvucawatqymuku Veqljgzhh Smlut Bqgawzf Kinenc Tatabanya Hungary
Hzvfnpab Qacnsttjohj Mdpxxc Malaga Spain
Mv Apruggrs Ctupwz Cphqwk Madrid Spain
Iohuurbw Mpd Sub z orhi Lodz Poland
Mggvrpypoioq Kysssdsgluf Hoaliahpienk gviuu Halle (Saale) Germany
Ebauipikebvp Lxthuzvwuobv Bsyoba Knqimtbqncitvbnvlfv gmmgj Berlin Germany
Rzefvro ulxsmrxxvpju mnedhki cwnkbvn Ssmqeiqjw Nijmegen 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
Recruiting
28.05.2026
France France
Recruiting
28.05.2026
Germany Germany
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)

Other Trials to Consider

  • Pumitamig Versus Pembrolizumab in Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%

    Recruiting

    3 1 1 1
    Investigated Drugs:
    Austria Belgium Bulgaria Czechia Finland France +10
  • Anti‑PD1 Therapy with pembrolizumab and cemiplimab in first‑line advanced non‑small cell lung cancer patients with high PD‑L1 expression

    Recruiting

    2 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    France