Visugromab + Immunochemotherapy for NSCLC

Recruiting at 12 trial locations

Overseen By Gerda Vlasitz-Kocks

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CatalYm GmbH

Must not be taking: Metformin

Disqualifiers: Squamous histology, Major organ failure, CNS involvement, Active autoimmune, 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

Compensation: Varies

Number of Visits: 2

107 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Visugromab, combined with standard cancer drugs, to determine its effectiveness for people with non-squamous non-small cell lung cancer that has metastasized. Researchers aim to discover if adding Visugromab to the usual treatment is more effective than the standard treatment alone. The trial targets individuals recently diagnosed with this type of lung cancer who lack specific genetic mutations requiring alternative treatments. Those newly diagnosed with this metastatic lung cancer and untreated for it may be suitable candidates for the trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who need to take metformin for type II diabetes. It's best to discuss your specific medications with the trial team.

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

Research has shown that treatment with Visugromab, a type of antibody, has been promising. Previous studies with patients who have non-small cell lung cancer (NSCLC) and urothelial cancer reported positive results, with patients experiencing lasting benefits from the treatment.

Regarding safety, earlier studies found that Visugromab was generally well-tolerated. Serious side effects directly linked to Visugromab were uncommon, indicating that the treatment is relatively safe.

This current study is in Phase 2, meaning Visugromab has already passed initial safety tests in humans. This phase focuses more on the drug's effectiveness and safety in a larger group. So far, the results are encouraging, but ongoing studies are needed to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Visugromab is unique because it introduces a new approach to treating non-small cell lung cancer (NSCLC) by combining with immunochemotherapy. Unlike the standard treatments, which typically involve drugs like pembrolizumab, pemetrexed, and carboplatin, Visugromab adds an experimental active ingredient that may enhance the immune system's ability to target cancer cells. Researchers are excited about Visugromab because it could potentially boost the effectiveness of existing chemotherapy and immunotherapy regimens, offering a more powerful attack against the cancer. This combination approach aims to improve outcomes for patients with NSCLC by enhancing the body’s natural immune response.

What evidence suggests that this trial's treatments could be effective for NSCLC?

This trial will compare Visugromab combined with immunochemotherapy to a placebo combined with immunochemotherapy for treating non-squamous non-small cell lung cancer (nsqNSCLC). Research shows that Visugromab may help treat this type of lung cancer. In an earlier study, patients with this cancer type experienced benefits from the treatment for more than 32 months on average, with over half of the patients seeing positive effects for at least 32 months. Visugromab has also been tested with another drug, nivolumab, and performed better than a placebo. These results suggest that Visugromab could work well when used with standard cancer treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Felix Lichtenegger, MD

Principal Investigator

CatalYm GmbH

Are You a Good Fit for This Trial?

This trial is for people with newly diagnosed metastatic non-squamous NSCLC who haven't had treatment before. Participants should be suitable for immunochemotherapy. Specific eligibility details are not provided, but typically include factors like age, overall health, and cancer stage.

Inclusion Criteria

My cancer can be measured by scans according to specific criteria.

My lung cancer is newly diagnosed, stage IV, and not squamous type.

I am 18 years old or older.

Exclusion Criteria

I had cancer before, but it's been cured and hasn't come back in over 5 years.

My cancer has spread to my brain.

I do not have active inflammatory bowel disease, diverticulitis, abscesses, or blockages in my digestive system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Non-randomized safety run-in part where participants receive Visugromab at the expansion dose

3 weeks

1 visit (in-person) every 3 weeks

Randomized Treatment

Participants receive either Visugromab or placebo in combination with Pembrolizumab, Pemetrexed, and Carboplatin

up to 24 months

1 visit (in-person) every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

• Visugromab

Trial Overview The trial tests Visugromab combined with a standard immunochemotherapy regimen (Pembrolizumab, Pemetrexed, Carboplatin) against a placebo plus the same chemotherapy drugs. It's randomized and blinded to compare effectiveness and safety in two groups.

How Is the Trial Designed?

Group I: Visugromab (CTL-002) + Immunochemotherapy Combination (SoC treatment) - Arm A Experimental Treatment 4 Interventions

Participants receive Visugromab (recommended dose), Pembrolizumab (200 mg), Pemetrexed (500 mg/m2) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments and Carboplatin target dose Area Under Curve (AUC) 5 (max. dose 750 mg) IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for four cycles.

Group II: Placebo + Immunochemotherapy Combination (SoC treatment) - Arm B Active Control 4 Interventions

Participants receive matching placebo for visugromab, Pembrolizumab (200 mg), Pemetrexed (500 mg/m2) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for up to 35 treatments and Carboplatin target dose Area Under Curve (AUC) 5 (max. dose 750 mg) IV on Day 1 of every 21-day cycle (every 3 weeks, or Q3W) for four cycles.

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/NCT07098988

NCT07098988 | Trial Investigating Visugromab in ... After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), ...

3. targetedonc.com targetedonc.com/view/trial-data-show-efficacy-tolerability-of-nivolumab-plus-visogromab-in-mibc

Trial Data Show Efficacy, Tolerability of Nivolumab Plus ... Nivolumab (Opdivo) plus visugromab showed superior efficacy to placebo and good tolerability in patients with newly diagnosed ...

4. forbion.com forbion.com/news-insights/news/catalym-announces-first-patient-dosed-in-phase-2b-trial-evaluating-visugromab-in-combination-with-chemoimmunotherapy-as-first-line-treatment-in-metastatic-non-squamous-nsclc/

CatalYm Announces First Patient Dosed in Phase 2b Trial The trial investigates the efficacy and safety of the company's anti-GDF-15 antibody visugromab, in combination with standard-of-care ...

5. biospace.com biospace.com/press-releases/catalym-presents-phase-2-data-in-neoadjuvant-bladder-cancer-demonstrating-substantial-increase-of-anti-tumor-activity-for-visugromab-in-combination-with-pd-1-inhibitor-at-esmo

CatalYm Presents Phase 2 Data in Neoadjuvant Bladder ... Visugromab combined with PD-1 inhibitor, nivolumab, more than quadrupled the rate of pathological Complete Response (pCR; 33.3% vs.

6. catalym.com catalym.com/catalym-announces-first-patient-dosed-in-phase-2b-trial-evaluating-visugromab-in-combination-with-chemoimmunotherapy-as-first-line-treatment-in-metastatic-non-squamous-nsclc/

CatalYm Announces First Patient Dosed in Phase 2b Trial ... The trial investigates the efficacy and safety of the company's anti-GDF-15 antibody visugromab, in combination with standard-of-care ...

7. urologytimes.com urologytimes.com/view/visugromab-shows-initial-efficacy-and-safety-in-urothelial-carcinoma

Visugromab shows initial efficacy and safety in urothelial ... Data from the UC and non-small cell lung cancer (NSCLC) cohorts of the study were presented at the European Society for Medical Oncology ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11779642/

Neutralizing GDF-15 can overcome anti-PD-1 and ... Here we show that durable and deep responses were achieved in some patients with non-squamous non-small cell lung cancer and urothelial cancer, two cancer ...