Overview

Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

Status:
RECRUITING

Trial end date:
2031-10-01

Target enrollment:

Participant gender:

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, 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).

Phase:

PHASE2

Details

Lead Sponsor:

CatalYm GmbH

Treatments:

Docetaxel
Nivolumab
Saline Solution