Sign inCreate account

Report workspace tools

NCT07246863RECRUITINGanonymous

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)

Sponsor

Source record

CatalYm GmbH

Phase

Source record

PHASE2

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Indication / condition

AI-normalized

Metastatic Non-Squamous Non-Small Cell Lung Cancer

Intervention

Source record

Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Source & freshness

Source record

NCT ID

NCT07246863

Original source

ClinicalTrials.gov

Source last updated

Jun 09, 2026

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT07246863

Title

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)

Sponsor

CatalYm GmbH

Status

RECRUITING

Phase

PHASE2

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

Interventions

Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Public preview

Source record

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).

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

Report access

Create an account to unlock this report

Choose the access model that matches the job: one urgent report, reusable credits for project work, or unlimited monthly access with AI and folders.

Full protocol, outcomes, eligibility, contacts and results sections
Patent/IP landscape with verified records when available
Board-ready PDF export with source provenance
Save to folders and synthesize multiple assets in premium workspace
Create account
Sign in

Create a free account first, then unlock a single report, buy credits or subscribe.

TrialSignal

Clinical trial intelligence report

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)

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT07246863

Status

RECRUITING

Phase

PHASE2

Sponsor

CatalYm GmbH

Executive brief

Investment-Ready Snapshot

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).

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJun 09, 2026
Internal syncJun 09, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT07246863

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

Intervention

Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion, Docetaxel

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.