Metastatic Non-Squamous Non-Small Cell Lung CancerPhase 2NCT07098988
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
A Phase 2 study testing Visugromab, Pembrolizumab 200 mg Q3W and Pemetrexed 500 mg/m^2 in people with Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, run by CatalYm GmbH at 51 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
- What is being tested?
- Visugromab, Pembrolizumab 200 mg Q3W and Pemetrexed 500 mg/m^2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 51 sitesin 7 countries
- Study dates
- 1 Aug 2025to 31 Mar 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.
- Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
- Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1.
- Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy.
- Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated.
- Availability of a tissue/histological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted.
- Age ≥ 18 years on the day of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function (bone marrow, hepatic, renal function and coagulation).
Main Exclusion Criteria:
- Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage).
- Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within < 3 months prior to planned treatment start).
- Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of study drug.
- Received potentially curative radiation therapy to the lung that is > 30 Gy within 6 months prior to the first dose of study drug.
- Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug.
- Expected to require any other form of antineoplastic therapy while on trial.
- Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction.
- Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- Known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis. Participants with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions.
- Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri/myocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start.
- Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.
- Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.
Trial locations and contacts
51 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 7 countries
Spain16 sites, 16 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
Edurne Arriola, Dr., earriola@hmar.cat
- Recruiting
Hospital Quiron Dexeus Barcelona
Barcelona, Catalonia, 08028
Roxana Reyes Dr., +34 935460135, rreyes@oncorosell.com
- Recruiting
Catalan Institute of Oncology of Girona
Girona, Girona, 17007
Bosch Barrera, Dr, +34 972 225 158, jbosch@iconcologia.net
- Recruiting
University Hospital of Jaen
Jaén, Andalusia, 23007
Jose Lopez Lopez, Dr., +34 (95) 322 0306, Jall92hs@gmail.com
- Recruiting
University Hospital Lucus Augusti (HULA)
Lugo, 27003
Sergio Vázquez Estévez, Dr., +34 (98) 229 6028, sergio.vazquez.estevez@sergas.es
- Recruiting
University Clinic of Navarra - Madrid
Madrid, Madrid, 28027
Miguel Fernandez de Sanmamed Gutierrez, Dr., +34 (91) 353 1920, msanmamed@unav.es
- Recruiting
University Hospital 12 de Octubre
Madrid, Madrid, 28041
Paz-Ares Rodríguez, Dr., +34 (91390) 8000, lpazaresr@seom.org
- Recruiting
University Hospital HM Sanchinarro
Madrid, Madrid, 28050
Gema Garcia Ledo, Dr., +34 9 1756 7984, gmgarcialedo@hmhospitales.com
- Recruiting
MD Anderson International Cancer Center Spain
Madrid, 28033
Fernando Fabio Franco Pérez Dr., +34 917 878 600, ffranco@fundacionmdanderson.es
- Recruiting
Regional University Hospital of Malaga
Málaga, Andalusia, 29010
Manuel Cobo Dols, Dr., +34 (95) 130 8130, mangel.cobo.sspa@juntadeandalucia.es
- Recruiting
University Clinic of Navarra - Pamplona
Pamplona, Chartered Community of Navarre, 31008
Miguel Fernandez de Sanmamed Gutierrez, Dr., +34 (91) 353 1920, msanmamed@unav.es
- Recruiting
START- Rioja
Rioja, La Rioja, 26006
Carme Bistuer Rovira, +34941278760, carme.bistuer@startresearch.com
- Recruiting
University Hospital Marques de Valdecilla (HUMV)
Santander, Cantabria, 39008
Marta Francisca Lopez-Brea Piqueras, Dr., +34 942202515, marta.lopezbrea@gmail.com
- Recruiting
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, Galicia, 15706
Estiban Mendez Barrio, +34 981 (955) 923, estiban.mendez.barrio@sergas.es
- Recruiting
University Hospital Virgen Macarena
Seville, Andalusia, 41009
David Vicente Baz, Dr., +34 671560092, dvicentebaz@yahoo.es
- Recruiting
University Hospital Virgen del Rocio (HUVR)
Seville, Andalusia, 41013
Amparo Sanchez Gastaldo, Dr., +34 955013068, asanchezgastaldo@gmail.com
United States13 sites, 13 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2936
Leigh McManus, RN, MSHQS, CCRP, 205-934-4173, lmcmanus@uabmc.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Meredith Hovart, 843-792-2423, Hovart@musc.edu
- Recruiting
Smilow Cancer Center, Derby
Derby, Connecticut, 06418
Jennifer Pope, (203) 494-3732, jennifer.pope@yale.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Alicia Wilkerson, 919-681-4768, Alicia.wilkerson@duke.edu
- Recruiting
Smilow Cancer Center, Guilford
Guilford, Connecticut, 06437
Jennifer Pope, (203) 494-3732, jennifer.pope@yale.edu
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sandy Tran, 323-865-3935, Sandy.Tran@med.usc.edu
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Rajwanth Veluswamy, Dr., 212-731-5662, rajwanth.veluswamy@nyulangone.org
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06519
Sarah Goldberg, MD, 203-785-7564, sarah.goldberg@yale.edu
- Recruiting
NYU Longone Health
New York, New York, 10016
Rajwanth Veluswamy, MD, 212-731-5662, rajwanth.veluswamy@nyulangone.org
- Recruiting
Smilow Cancer Hospital - North Haven
North Haven, Connecticut, 06473
Jennifer Pope, (203) 494-3732, jennifer.pope@yale.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Anahid Aminpour, 813-745-0287, Anahid.Aminpour@moffitt.org
- Recruiting
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611
Jennifer Pope, (203) 494-3732, jennifer.pope@yale.edu
- Recruiting
Smilow Cancer Hospital - Waterbury
Waterbury, Connecticut, 06708
Jennifer Pope, (203) 494-3732, jennifer.pope@yale.edu
Germany6 sites, 6 recruiting
- Recruiting
Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift
Bielefeld, North Rhine-Westphalia, 33611
Florian Weissinger, Prof., +49 (521) 77275750, florian.weissinger@evkb.de
- Recruiting
Clinics Essen-Mitte
Essen, North Rhine-Westphalia, 45136
Konstantinos Ferentinos, Dr., +49 (201) 174-24061, K.Ferentinos@kem-med.com
- Recruiting
Großhansdorf Hospital - Clinical Center for Pulmonology and Thoracic Surgery, Department of Thoracic Oncology
Großhansdorf, Schleswig-Holstein, 22927
Martin Reck, Dr., 04102 / 601-2101, m.reck@lungenclinic.de
- Recruiting
Thorax Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Helge Bischoff, +49 (6221) 396 8304, helge.bischoff@med.uni-heidelberg.de
- Recruiting
Foundation Bethanien Moers
Moers, North Rhine-Westphalia, 47441
Kato Kambartel Dr., +49 2841 200 2297, kambartel@bethanienmoers.de
- Recruiting
University Hospital Würzburg
Würzburg, Bavaria, 97080
Maria- Elisabeth Göbeler, +49 (931) 201 40959, goebeler_m@ukw.de
Italy6 sites, 6 recruiting
- Recruiting
Oncology Reference Center
Aviano, 33081
Brigida Stanzione Dr., brigida.stanzione@cro.it
- Recruiting
Institute of Cancer Research and Treatment of Candiolo
Candiolo, Candiolo, 10060
Vanesa Gregorc, Dr., +39 0119933915, vanesa.gregorc@inoc.it
- Recruiting
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
Meldola, Forli, 47014
Oriana Nanni, +39 0543739100, oriana.nanni@irst.emr.it
- Recruiting
National Cancer Institute, IRCCS
Milan, Milan, 20133
Giuseppe Lo Russo, Dr., +390223903829, giuseppe.lorusso@istitutotumori.mi.it
- Recruiting
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department
Ravenna, 48121
Manolo D'Arcangelo, Dr., +390544286223, manolo.darcangelo@auslromagna.it
- Recruiting
National Cancer Institute Regina Elena, IRCCS
Rome, 00144
Lorenza Landi, Dr., +3906.5266.2205-06, lorenza.landi@ifo.it
Romania4 sites, 4 recruiting
- Recruiting
"Sf. Nectarie" Oncology Center, Department of Medical Oncology
Craiova, Dolj, 200542
Michael Schenker, Dr., +40 727 774 974, mike_schenker@yahoo.com
- Recruiting
Gral Medical S.R.L. - Oncofort Hospital
Piteşti, 110283
Adela Luiza Chirila, Dr., +40 766442720, dr.adela_chirila@yahoo.com
- Recruiting
Clinica Polisano S.R.L.
Sibiu, 550253
Victor Nimirceag, Dr., +40 (74) 103 3998, Dr.Nimirceag@gmail.com
- Recruiting
SC Oncomed SRL, Department of Medical Oncology
Timișoara, +40 () 727 774 974
Daniela Sirbu, Dr., +40 (744) 571 617, desirbu@yahoo.com
Poland3 sites, 3 recruiting
- Recruiting
University Teaching Hospital No. 4 in Lublin, Multi-Profile Non-Invasive Treatment Department
Lublin, Lublin Voivodeship, 20-090
Izabela Chmielewska, Dr, +48 81 724 48 18, izachm@wp.pl
- Recruiting
MED-Polonia, Sp. z o.o. (LLC)
Poznan, 60-693
Rodryg Ramlau, Dr., +48 513 155 613, badania.kliniczne@medpolonia.com.pl
- Recruiting
Specialist Hospital in Prabuty Sp. z o.o. (LLC), Department of Pulmonology
Prabuty, 82-550
Anna Lowczak, Dr., +48 552 624 351, onkoania@gazeta.pl
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel
Basel, Basel, 4031
Benjamin Thiele, Dr., +41 (612) 655 074, Benjamin.Thiele@usb.ch
- Recruiting
Fribourg Cantonal Hospital
Fribourg, Canton of Fribourg, 1708
Alessandra Curioni, Dr., +41 26 306 20 15, Alessandra.Curioni-Fontecedro@h-fr.ch
- Recruiting
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, Canton of St. Gallen, 9007
Markus Jörger, Dr., +41 (71) 494 1111, markus.joerger@h-och.ch
About this study
Official title: A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-01)
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).
- Being tested
- Visugromab, Matching placebo for visugromab, Pembrolizumab 200 mg Q3W, Pemetrexed 500 mg/m^2, Carboplatin AUC 5
- Keywords
- CTL-002, Visugromab, GDF-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisugromabBiological
Also called CTL-002
Participants receive Visugromab (recommended dose) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Matching placebo for visugromabDrug
Participants receive Matching Placebo intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Pembrolizumab 200 mg Q3WBiological
Also called Keytruda®
Participants receive Pembrolizumab 200 mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments after visugromab infusion.
Pemetrexed 500 mg/m^2Drug
Participants receive Pemetrexed 500 mg/m^2 IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments.
Carboplatin AUC 5Drug
Participants receive Carboplatin target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) on Day 1 of each 21-day cycle for four cycles.
| Study group | Role | What they receive |
|---|---|---|
| Visugromab (CTL-002) + Immunochemotherapy Combination (SoC treatment) - Arm A | Experimental | Participants receive Visugromab (recommended dose), Pembrolizumab (200 mg), Pemetrexed (500 mg/m2) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments and Carboplatin target dose Area Under Curve (AUC) 5 (max. dose 750 mg) IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for four cycles. Receives: Biological: Visugromab; Biological: Pembrolizumab 200 mg Q3W; Drug: Pemetrexed 500 mg/m^2; Drug: Carboplatin AUC 5 |
| Placebo + Immunochemotherapy Combination (SoC treatment) - Arm B | Active comparator | Participants receive matching placebo for visugromab, Pembrolizumab (200 mg), Pemetrexed (500 mg/m2) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments and Carboplatin target dose Area Under Curve (AUC) 5 (max. dose 750 mg) IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for four cycles. Receives: Drug: Matching placebo for visugromab; Biological: Pembrolizumab 200 mg Q3W; Drug: Pemetrexed 500 mg/m^2; Drug: Carboplatin AUC 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator at any time during the core trial period
Measured: up to 24 months
Secondary outcomes (13)
Adverse Events
Incidence, type and severity of adverse events, treatment emergent adverse events, treatment-related adverse events and serious adverse events
Measured: up to 27 months
CR rate
Complete response rate
Measured: up to 24 months
PR rate
Partial response rate
Measured: up to 24 months
DOR
Duration of response
Measured: up to 24 months
ORR
Objective response rate
Measured: up to 24 months
TTR
Time-to-response rate
Measured: up to 24 months
PFS
Progression-free survival
Measured: up to 48 months
OS
Overall survival
Measured: up to 48 months
Participant weight course over time
Measured: up to 48 months
Maximum Concentration (Cmax) of visugromab
Cmax is the maximum observed serum concentration of visugromab
Measured: At designated time points (up to 24 months)
Minimum Concentration (Cmin) of visugromab
Cmin is the minimum observed serum concentration of visugromab
Measured: At designated time points (up to 24 months)
Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
NSCLC-SAQ is a participant reported outcome with seven (7) items assessing five (5) symptom domains of NSCLC: cough, fatigue, pain, dyspnea, and appetite. Each item is scored individually from 0 ("None/Never") to 4 ("Severe/Always"). The total score is calculated by summing domain scores, which are derived as follows: single-item domains (cough, dyspnea, appetite) use the item score; fatigue uses the mean of two items (or one if only one is answered); pain uses the highest score of two items (or one if only one is answered). The total score ranges from 0-20, with higher scores indicating more severe symptoms. If any domain score is missing, a total score is not computed.
Measured: up to 27 months
Participants' quality of life as assessed by 5-day Functional Living Index-Emesis (5-day FLIE)
FLIE consists of 18 items, with 9 items on nausea and 9 items on vomiting. The impact of nausea and vomiting is assessed through their effects on physical and social activities, and emotional well-being. Each item is rated using a visual analog scale (VAS) from 1 to 7 (In some questions, "1" means that nausea or vomiting does not affect the daily life at all, while in other questions, "1" means it affects the daily life a lot). Scoring is calculated per the FLIE Scoring and Administration Manual. Higher scores indicate less impact of nausea and vomiting on daily life. At least 12 of 18 items must be completed to compute the total score.
Measured: At designated time points (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A: Safety Run-In Part B and Part C: Randomized Part The randomized part consists of two arms: Visugromab + ICT (Arm A) and Placebo + ICT (Arm B) Participants will be allocated in 2:1 ratio to treatment arm A or B.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CatalYm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Lichtenegger, MD, Study director, CatalYm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098988
- Sponsor's protocol ID
- CTL-002-003
- Other IDs
- 2024-516792-32-01
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No