Metastatic Non-Squamous Non-Small Cell Lung CancerPhase 2NCT07246863
Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
A Phase 2 study testing Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg and Nivolumab in people with Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, run by CatalYm GmbH at 36 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) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel… 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 RDE (recommended dose for expansion), Visugromab 6mg/kg and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 7 Oct 2025to 1 Oct 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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:
- Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
- Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment.
- Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
- Participants must have life expectancy of at least 3 months as assessed by the Investigator.
- Participants must have ECOG performance status ≤1.
Main Exclusion Criteria:
- Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
- Participants must not have a prior malignancy requiring treatment.
- Participants must not have a 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 must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
Trial locations and contacts
36 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 7 countries
Spain13 sites, 13 recruiting
- Recruiting
Hospital Quiron Dexeus Barcelona
Barcelona, Barcelona, 08028
Andres Aguilar Hernandez, Dr, +34 (93) 546 0135, aaguilar@oncorosell.com
- Recruiting
Hospital Clinic of Barcelona
Barcelona, Catalonia, 08036
Laura Mezquita, Dr, + 34 932275402, lmezquita@clinic.cat
- Recruiting
University Hospital of Girona Dr. Josep Trueta
Girona, Girona, 17007
Joaquim 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
START- Rioja
Logroño, La Rioja, 26006
Carme Bistuer Rovira, +34941278760, carme.bistuer@startresearch.com
- Recruiting
University Hospital Lucus Augusti (HULA)
Lugo, 27003
Sergio Vázquez Estévez, Dr, +34 (98) 229 6028, sergio.vazquez.estevez@sergas.es
- Recruiting
Clínica Universidad de Navarra
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
Luis Paz-Ares Rodríguez, Dr, +34 (91390) 8000, lpazaresr@seom.org
- Recruiting
University Hospital HM Sanchinarro
Madrid, Madrid, 28050
Gema Garcia Ledo, Dr, +34 (91) 756 7984, gmgarcialedo@hmhospitales.com
- 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, Navarre, 31008
Miguel Fernandez de Sanmamed Gutierrez, Dr, +34 (91) 353 1920, msanmamed@unav.es
- 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 del Rocio (HUVR)
Seville, Andalusia, 41013
Amparo Sánchez Gastaldo, Dr, +34 955013068, asanchezgastaldo@gmail.com
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
Hospital Esslingen GmbH
Esslingen am Neckar, Baden-Wurttemberg, 73730
Martin Faehling, Dr, +49711310382411, m.faehling@klinikum-esslingen.de
Annika Landmesser, +49711310386510, a.landmesser@klinikum-esslingen.de
- Recruiting
Thorax Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Helge Bischoff, Dr, +49 (6221) 396 8304, helge.bischoff@med.uni-heidelberg.de
Petra Kettenring, +49 (6221) 396 1359, Petra.Kettenring@med.uni-heidelberg.de"
- Recruiting
Foundation Bethanien Moers
Moers, North Rhine-Westphalia, 47441
Kato Kambartel, Dr, +49 2841 200 2297, kambartel@bethanienmoers.de
Sylvia Quabeck, Dr, +49 2841 200 2297, Sylvia.Quabeck@bethanienmoers.de
- Recruiting
University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology
Würzburg, Bavaria, 97080
Maria Elisabeth Goebeler, Dr, +49 93120140959, goebeler_m@ukw.de
Italy6 sites, 6 recruiting
- Recruiting
Oncology Reference Center
Aviano, Friuli Venezia Giulia, 33081
Brigida Stanzione, Dr, +39 0434659314, brigida.stanzione@cro.it
- Recruiting
Institute of Cancer Research and Treatment of Candiolo
Candiolo, Turin, 10060
Vanesa Gregorc, Dr, +39 0119933915, vanesa.gregorc@inoc.it
- Recruiting
Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST
Forlì, Emilia-Romagna, 47014
Oriana Nanni, Dr, +39 0543739100, oriana.nanni@irst.emr.it
- Recruiting
European Institute of Oncology (IEO), IRCCS
Milan, Milan, 20141
Pamela Trillo Aliaga, Dr, +390257489773, Pamela.TrilloAliaga@ieo.it
- Recruiting
Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematology Department
Ravenna, 48121
Manolo D'Arcangelo, Dr, +39 0544286223, manolo.darcangelo@auslromagna.it
- Recruiting
National Cancer Institute Regina Elena, IRCCS
Rome, Lazio, 00144
Gabriele Minuti, Dr, +39 06 5266 2205 ext. 06, gabriele.minuti@ifo.it
United States5 sites, 5 recruiting
- Recruiting
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, Alabama, 35294-3300
Leigh McManus, RN, MSHQS, CCRP, 205-934-4173, lmcmanus@uabmc.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Alicia Wilkerson, 919-681-4768, Alicia.wilkerson@duke.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
David Mangar, 212-404-3628, david.mangar@nyulangone.org
- Recruiting
NYU Longone Health
New York, New York, 10016
Rajwanth Veluswamy, Dr, 212-731-5662, rajwanth.veluswamy@nyulangone.org
David Mangar, 212-404-3628, david.mangar@nyulangone.org
Romania3 sites, 3 recruiting
- Recruiting
Sf. Nectarie Oncology Center
Craiova, Dolj, 200542
Michael Schenker, Dr, +40 727 774 974, mike_schenker@yahoo.com
Augustin Georghe, +40 723 557 512, gusti.gheorghe@yahoo.com
- Recruiting
Clinica Polisano S.R.L
Sibiu, Sibiu County, 55023
Victor Nimirceag, Dr, +40 (74) 103 3998, Dr.Nimirceag@gmail.com
Nicoleta Dalbea, +40 (752) 888 592, nicoleta.dalbea@medlife.ro
- Recruiting
SC Oncomed SRL
Timișoara, Timiș County, 300239
Daniela Sirbu, Dr, +40 (744) 571 617, desirbu@yahoo.com
Georgeta Negret, Pharm, +40 (728) 963 979, gnegret28@gmail.com
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Benjamin Thiele, Dr, +41 (612) 655 074, Benjamin.Thiele@usb.ch
- Recruiting
Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology
Sankt Gallen, CH-9007
Markus Joerger, Dr, +41 (71) 494 1111, markus.joerger@h-och.ch
Poland1 site, 1 recruiting
- Recruiting
MED-Polonia, Sp. z o.o. (LLC)
Poznan, Greater Poland Voivodeship, 60693
Rodrig Ramlau, Dr, +48 513 155 613, badania.kliniczne@medpolonia.com.pl
About this study
Official title: Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)
This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).
The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visugromab RDE (recommended dose for expansion)Biological
Also called CTL-002
Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Visugromab 6mg/kgBiological
Also called CTL-002
Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
NivolumabBiological
Also called OPDIVO®
Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Placebo Saline InfusionOther
Also called 0.9% NaCl
Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
DocetaxelDrug
Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Visugromab (RDE) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) Receives: Biological: Visugromab RDE (recommended dose for expansion); Biological: Nivolumab; Drug: Docetaxel |
| Arm B | Experimental | Visugromab (6mg/kg) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) Receives: Biological: Visugromab 6mg/kg; Biological: Nivolumab; Drug: Docetaxel |
| Arm C | Experimental | Visugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline) intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) Receives: Biological: Visugromab RDE (recommended dose for expansion); Biological: Nivolumab |
| Arm D | Active comparator | Double Placebo (Saline) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) Receives: Other: Placebo Saline Infusion; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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 36 months
Secondary outcomes (12)
Adverse Events
Incidence, type and severity of adverse events, treatment emergent adverse events, treatment-related adverse events and serious adverse events
Measured: up to 60 months
CR rate
Complete response rate
Measured: up to 36 months
PR rate
Partial response rate
Measured: up to 36 months
ORR rate
Overall response rate
Measured: up to 36 months
DOR
Duration of response
Measured: up to 36 months
TTR
Time-to-respond
Measured: up to 36 months
PFS
Progression-free survival
Measured: up to 60 months
OS
Overall survival
Measured: up to 60 months
Participant weight course over time
Participant weight course over time
Measured: up to 39 months
Maximum Concentration (Cmax) of visugromab
Cmax is the maximum observed serum concentration of visugromab.
Measured: up to 36 months
Minimum Concentration (Cmin) visugromab
Cmin is the minimum observed serum concentration of visugromab
Measured: up to 36 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 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start7 Oct 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 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 C: Randomized Part consists of 4 Arms: Arm A: Visugromab at the recommended dose for expansion (RDE) with Nivolumab and Docetaxel, Arm B: Visugromab 6 mg/kg with Nivolumab and Docetaxel, Arm C: Visugromab at the RDE with Nivolumab Arm D: Double Placebo (saline) and Docetaxel Participants will be allocated in 2:1:1:1 ratio to treatment arms A, B, C, or D
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CatalYm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lena Lemke, MD, Study director, CatalYm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246863
- Sponsor's protocol ID
- CTL-002-004
- Other IDs
- 2024-516794-70-00
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)
- ClinicalTrials.gov ID
- NCT07246863
- Acronym / sponsor ID
- CTL-002-004
- Keywords
- CTL-002, Visugromab, GDF-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- CatalYm GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).
The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Part A: Safety Run-In Part B and C: Randomized Part consists of 4 Arms: Arm A: Visugromab at the recommended dose for expansion (RDE) with Nivolumab and Docetaxel, Arm B: Visugromab 6 mg/kg with Nivolumab and Docetaxel, Arm C: Visugromab at the RDE with Nivolumab Arm D: Double Placebo (saline) and Docetaxel Participants will be allocated in 2:1:1:1 ratio to treatment arms A, B, C, or D
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Visugromab RDE (recommended dose for expansion), Biological: Nivolumab, Drug: DocetaxelVisugromab (RDE) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) |
| Arm B | Experimental | Biological: Visugromab 6mg/kg, Biological: Nivolumab, Drug: DocetaxelVisugromab (6mg/kg) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) |
| Arm C | Experimental | Biological: Visugromab RDE (recommended dose for expansion), Biological: NivolumabVisugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline) intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W) |
| Arm D | Active comparator | Other: Placebo Saline Infusion, Drug: DocetaxelDouble Placebo (Saline) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visugromab RDE (recommended dose for expansion)Also: CTL-002Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) | Biological | Arm A, Arm C |
| Visugromab 6mg/kgAlso: CTL-002Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) | Biological | Arm B |
| NivolumabAlso: OPDIVO®Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) | Biological | Arm A, Arm B, Arm C |
| Placebo Saline InfusionAlso: 0.9% NaClParticipants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) | Other | Arm D |
| DocetaxelParticipants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) | Drug | Arm A, Arm B, Arm D |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 36 months
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
12 secondary outcomes
Adverse Events
Time frame: up to 60 months
CR rate
Time frame: up to 36 months
PR rate
Time frame: up to 36 months
ORR rate
Time frame: up to 36 months
DOR
Time frame: up to 36 months
TTR
Time frame: up to 36 months
PFS
Time frame: up to 60 months
OS
Time frame: up to 60 months
Participant weight course over time
Time frame: up to 39 months
Maximum Concentration (Cmax) of visugromab
Time frame: up to 36 months
Minimum Concentration (Cmin) visugromab
Time frame: up to 36 months
Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Time frame: up to 39 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lena Lemke, MD study director
CatalYm GmbH
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg and Nivolumab in people with Metastatic Non-Squamous Non-Small Cell Lung Cancer and Adult Solid Tumor, run by CatalYm GmbH at 36 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Spain, Germany, Italy, United States, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lena Lemke, MD (+49 89 200066440, regulatory-004@catalym.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.