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Trial Investigating Visugromab and Nivolumab With or Without Docetaxel for Metastatic NSCLC

This study is for people with metastatic non-squamous non-small cell lung cancer (NSCLC) that has progressed after initial treatment, including a checkpoint inhibitor. It is testing different combinations of Visugromab, Nivolumab, and Docetaxel, or a placebo. You would be eligible if you have stage IV non-squamous NSCLC and do not have certain genetic changes (like EGFR or ALK mutations) that would be treated with other targeted medicines. The main goal is to see how many participants respond to the treatments, measured for up to 36 months. The study plans to enroll 131 participants.

Study design
This is a randomized, placebo-controlled, blinded, multi-center Phase 2b study. It involves 131 participants and has an initial safety part followed by a randomized section with four treatment groups.
What's involved
Participants will receive study treatments intravenously (IV) on Day 1 of every 21-day cycle (every 3 weeks). The trial record does not specify other visits, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how participants respond to treatment for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07246863

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
CatalYm GmbH
~131 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Visugromab RDE (recommended dose for expansion)Visugromab 6mg/kgNivolumabPlacebo Saline InfusionDocetaxel

At a glance

Recruiting sites
34 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over up to 36 months

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Cancer
Adult Solid Tumor

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

34 sites across 25 states
North Rhine-Westphalia3
Andalusia3
Madrid3
New York2
Baden-Wurttemberg2
Switzerland2
Alabama1
California1

Study leadership

  • Lena Lemke, MD · STUDY_DIRECTOR · CatalYm GmbH

Who to contact

Lena Lemke, MD
[email protected]
+49 89 200066440
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Objective Response Rate (ORR)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