RecruitingPhase II🇵🇱 PolandEN originalLung cancerMetastatic / advanced

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rak płuca niedrobnokomórkowy w stadium IV, który nie jest typu płaskonabłonkowego.
  • Brak mutacji genetycznych, które można leczyć innymi dostępnymi lekami.
  • Potwierdzone przez lekarza zmiany widoczne w badaniach obrazowych.
  • Nie były leczone wcześniej na zaawansowanego raka płuca.
  • Badanie poziomu PD-L1 we krwi lub tkance nowotworowej (szczegóły u lekarza).
  • Dostępna próbka tkanki nowotworowej do dalszych badań i zgoda na jej wykorzystanie.
  • Wiek co najmniej 18 lat.
  • Ogólny stan zdrowia pozwalający na aktywność (skala ECOG 0-1).

✗ Disqualifies

  • Rak płuca typu płaskonabłonkowego lub drobnokomórkowego.
  • Aktywne lub niedawne poważne problemy z sercem lub innymi narządami.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 1, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (40)

University of Alabama at Birmingham

Birmingham, United States

USC Norris Comprehensive Cancer Center

Los Angeles, United States

Yale Cancer Center

New Haven, United States

Moffitt Cancer Center

Tampa, United States

NYU Longone Health

New York, United States

Duke University Medical Center

Durham, United States

Medical University of South Carolina

Charleston, United States

Thorax Clinic Heidelberg

Heidelberg, Germany

University Hospital Würzburg

Würzburg, Germany

Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift

Bielefeld, Germany

Clinics Essen-Mitte

Essen, Germany

Foundation Bethanien Moers

Moers, Germany

Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology

Großhansdorf, Germany

Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST

Meldola, Italy

Oncology Reference Center

Aviano, Italy

Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department

Ravenna, Italy

National Cancer Institute Regina Elena, IRCCS

Rome, Italy

MED-Polonia, Sp. z o.o. (LLC)

Poznan, Poland

Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology

Prabuty, Poland

"Sf. Nectarie" Oncology Center, Department of Medical Oncology

Craiova, Romania

Gral Medical S.R.L. - Oncofort Hospital

Piteşti, Romania

Clinica Polisano S.R.L.

Sibiu, Romania

SC Oncomed SRL, Department of Medical Oncology

Timișoara, Romania

University Hospital of Jaen

Jaén, Spain

Regional University Hospital of Malaga

Málaga, Spain

University Hospital Virgen Macarena

Seville, Spain

University Hospital Virgen del Rocio (HUVR)

Seville, Spain

University Hospital Marques de Valdecilla (HUMV)

Santander, Spain

Hospital del Mar

Barcelona, Spain

Hospital Quiron Dexeus Barcelona

Barcelona, Spain

University Clinic of Navarra - Pamplona

Pamplona, Spain

University Hospital Complex of Santiago (CHUS)

Santiago de Compostela, Spain

START- Rioja

Rioja, Spain

University Hospital 12 de Octubre

Madrid, Spain

University Hospital HM Sanchinarro

Madrid, Spain

University Hospital Lucus Augusti (HULA)

Lugo, Spain

MD Anderson International Cancer Center Spain

Madrid, Spain

University Hospital Basel

Basel, Switzerland

Fribourg Cantonal Hospital

Fribourg, Switzerland

Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology

Sankt Gallen, Switzerland

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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