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NCT07098988
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Phase 2 trial testing Visugromab in Metastatic Non-Squamous Non-Small Cell Lung Cancer in 107 participants. Currently enrolling.
31 March 2029
Quick facts
| Lead sponsor | CatalYm GmbH |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 107 |
| Start date | 1 August 2025 |
| Primary completion | 31 March 2029 |
| Estimated completion | 31 March 2031 |
| Sites | 25 locations across Italy, Germany, Romania, Switzerland, United States, Spain |
Drugs / interventions tested
- Visugromab — full drug profile →
- Matching placebo for visugromab — full drug profile →
- Pembrolizumab 200 mg Q3W — full drug profile →
- Pemetrexed 500 mg/m^2 — full drug profile →
- Carboplatin AUC 5 — full drug profile →
Conditions studied
- Metastatic Non-Squamous Non-Small Cell Lung Cancer — all drugs for Metastatic Non-Squamous Non-Small Cell Lung Cancer →
- Adult Solid Tumor — all drugs for Adult Solid Tumor →
Sponsor
CatalYm GmbH — full company profile →
Who can join
18 and older, any sex, with Metastatic Non-Squamous Non-Small Cell Lung Cancer or Adult Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07098988
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Non-Squamous Non-Small Cell Lung Cancer
Currently open trials in the same condition.
- NCT07246863 — Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic N · Phase 2 · recruiting
Other CatalYm GmbH trials
Trials by the same sponsor.
- NCT07246863 — Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic N · Phase 2 · recruiting
- NCT06059547 — Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer · Phase 2 · active not recruiting
- NCT04725474 — First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07098988 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CatalYm GmbH
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07098988.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing