Visugromab + Nivolumab for Non-Small Cell Lung Cancer

Recruiting at 4 trial locations

Overseen By Gerda Vlasitz-Kocks, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CatalYm GmbH

Must not be taking: Corticosteroids, Immunosuppressive drugs

Disqualifiers: Prior malignancy, CNS involvement, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

131 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatment options for individuals with non-small cell lung cancer (NSCLC) that has spread and not responded to initial treatments. The focus is on combining two drugs, Visugromab (an experimental treatment) and Nivolumab (an immunotherapy drug), to determine if they work better together with the chemotherapy drug Docetaxel, compared to a placebo. Participants will be sorted into different groups to compare the effects of these treatments. This trial suits those with stage IV non-squamous NSCLC without certain genetic mutations who have already tried one line of treatment, including a checkpoint inhibitor, without success. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to explore potentially effective new therapies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining Visugromab and Nivolumab may help treat various cancers, including non-small cell lung cancer (NSCLC). Earlier studies found that most patients tolerated this treatment well, with some experiencing benefits lasting over two years.

Regarding safety, past patients managed the treatment with side effects similar to those of other cancer treatments. This combination remains under study, and while early results are promising, more information is needed to fully understand its safety. The current trial phase aims to gather more detailed safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Visugromab is unique because it combines with Nivolumab to offer a novel approach for treating non-small cell lung cancer. Unlike traditional treatments like chemotherapy alone, Visugromab is an antibody targeting a specific protein on cancer cells, potentially enhancing the effectiveness of immune-based therapies. This combination approach aims to boost the body's immune response against the cancer more effectively. Researchers are excited about this treatment because it might provide improved outcomes for patients by directly targeting cancer cells while also engaging the immune system in a more robust way.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial will evaluate different combinations of Visugromab and Nivolumab for treating non-small cell lung cancer (NSCLC). Research has shown that combining Visugromab and Nivolumab holds promise for NSCLC, with studies finding that patients using this combination often had their cancer controlled for more than two years. Visugromab targets a protein called GDF-15, which can help tumors resist treatment, while Nivolumab aids the immune system in fighting cancer. Together, these drugs may help overcome resistance and improve treatment outcomes. Participants in this trial will receive different combinations of these drugs, with some also receiving Docetaxel or a placebo, to assess their effectiveness. ^{2 3 5 6 7}

Who Is on the Research Team?

Lena Lemke, MD

Principal Investigator

CatalYm GmbH

Are You a Good Fit for This Trial?

This trial is for people with a type of lung cancer called non-squamous NSCLC, who have already tried one treatment that didn't work. They should not have had previous treatments with Docetaxel or certain other drugs and must be in good enough health to receive second-line therapy.

Inclusion Criteria

I've had one treatment for advanced lung cancer that didn't work, despite not getting worse for the first 12 weeks.

Participants must have life expectancy of at least 3 months as assessed by the Investigator

My cancer can be measured by scans.

Exclusion Criteria

My cancer has not spread to my brain or caused any symptoms there.

I haven't taken medication for an autoimmune disease in the last 3 months.

I do not have lung disease or a history of serious lung inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in (Part A)

Open-label safety run-in to assess initial safety and dosing of Visugromab with Nivolumab and Docetaxel

3 weeks

1 visit every 3 weeks

Randomized Treatment (Part B and C)

Randomized phase 2b treatment with 4 arms, including interim safety and efficacy analysis after treatment of 15 participants

up to 36 months

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Nivolumab
• Visugromab

Trial Overview The study tests Visugromab at two doses and Nivolumab, both with and without the chemotherapy drug Docetaxel, compared to a placebo. It's randomized and blinded, meaning participants are put into groups by chance and don't know which treatment they're getting.

How Is the Trial Designed?

Group I: Arm C Experimental Treatment 3 Interventions

Visugromab (RDE) + Nivolumab (360 mg) + Placebo (Saline) intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)

Group II: Arm B Experimental Treatment 3 Interventions

Visugromab (6mg/kg) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)

Group III: Arm A Experimental Treatment 3 Interventions

Visugromab (RDE) + Nivolumab (360 mg) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle every 3 weeks (Q3W)

Group IV: Arm D Active Control 2 Interventions

Double Placebo (Saline) + Docetaxel (75 mg/m2), intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Who Is Running the Clinical Trial?

CatalYm GmbH

Lead Sponsor

Trials

2

Recruited

300+

Citations

1. catalym.com catalym.com/catalym-presents-long-term-phase-1-2a-data-confirming-sustained-responses-with-visugromab-in-cpi-refractory-tumors-at-esmo-2025/

CatalYm Presents Long-Term Phase 1/2a Data Confirming ... Median duration of response exceeded 32 months in non-squamous non-small cell lung cancer (nsqNSCLC), 28 months in urothelial cancer (UC) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07246863?rank=10

Trial Investigating Visugromab and Nivolumab With or ... This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody ...

3. targetedonc.com targetedonc.com/view/visugromab-plus-nivolumab-shows-durable-response-in-refractory-tumors

Visugromab Plus Nivolumab Shows Durable Response in ... Visugromab combined with nivolumab showed a median duration of response exceeding two years in refractory NSCLC, UC, and HCC patients. GDF-15 is ...

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/visugromab-nivolumab-combo-triumphs-in-advanced-cancer-battle/

Visugromab/Nivolumab Combo Triumphs in Advanced ... CatalYm's “GDFATHER” Phase 1/2a trial has shown promising results for its lead candidate, visugromab, in combination with nivolumab, an anti-PD-1 antibody.

5. biogenerationventures.com biogenerationventures.com/en/news/catalym_announces_first_patient_dosed_in_phase_2b_trial_evaluating_visugromab_in_combination_with_chemoimmunotherapy_as_first_li

CatalYm Announces First Patient Dosed in Phase 2b Trial ... This trial marks an important step in evaluating visugromab's potential to overcome this resistance and improve outcomes in a setting with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07246863

Trial Investigating Visugromab and Nivolumab With or ... This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody ...

7. nature.com nature.com/articles/s41586-024-08305-z

Neutralizing GDF-15 can overcome anti-PD-1 and ... Two additional patients experienced prolonged disease stabilization longer than 6 months (1 × non-small cell lung cancer (NSCLC) and 1 × ocular ...