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).
Indication: Metastatic Non-Squamous Non-Small Cell Lung Cancer
Modality: monoclonal antibody
Target: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel
Sponsor: CatalYm GmbH
Source URL: ClinicalTrials.gov
Source updated: Jun 09, 2026
Ingested: Jun 09, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by conditions: Adult Solid Tumor
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Condition raw: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Condition normalized: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
Modality raw: monoclonal antibody
Modality normalized: monoclonal antibody
Target raw: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel
Target normalized: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel