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Visugromab and Nivolumab with or without Docetaxel in 2L Metastatic Non-Squamous NSCLC
NCT07246863Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- Oct 2029
- Countries
- 7
- Sponsor
- CatalYm
- Drugs
- visugromab
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
01
Overview
Phase 2, randomised, double-blind trial of visugromab in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (4 arms), sponsored by CatalYm. Primary endpoint: Objective Response Rate up to 36 months. Started Oct 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Visugromab (RDE) + Nivolumab + Docetaxel
Visugromab (RDE) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), IV Q3W
Visugromab (6mg/kg) + Nivolumab + Docetaxel
Visugromab (6mg/kg) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), IV Q3W
Visugromab (RDE) + Nivolumab + Placebo
Visugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline), IV Q3W
Double Placebo + Docetaxel
Double Placebo (Saline) + Docetaxel (75 mg/m2), IV Q3W
03
Who it enrols
Adults with stage IV non-squamous NSCLC without actionable mutations (EGFR, ALK) who failed exactly one prior line of systemic therapy containing a PD-(L)1 inhibitor (with at least 12 weeks exposure and no progression during that period, but failure under ongoing CPI). Must have measurable disease, ECOG 0-1, and life expectancy >= 3 months. Excludes patients with active CNS metastases, active autoimmune disease, or history of interstitial lung disease/pneumonitis.
04
Endpoints
Primary
Objective Response Rate
Secondary
Adverse Events
Complete Response Rate
Partial Response Rate
Duration of Response
Time to Response
Progression-Free Survival
Overall Survival
Participant weight course over time
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