Visugromab with Immunochemotherapy for Metastatic Lung Cancer
This study is testing a new treatment combination for people with newly diagnosed metastatic non-squamous non-small cell lung cancer (a type of lung cancer that has spread and does not have certain genetic changes like EGFR or ALK). You would receive Visugromab, an antibody, along with standard immunochemotherapy (Pembrolizumab, Pemetrexed, and Carboplatin). Some participants will receive a placebo (an inactive substance) instead of Visugromab. The main goal is to see how many participants respond to the treatment, measured over up to 24 months. The study aims to enroll 107 participants and is currently in an unclear status regarding recruitment.
- Study design
- This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial involving 107 participants.
- What's involved
- Participants will receive intravenous (IV) treatments on Day 1 of every 21-day cycle for up to 35 treatments. Carboplatin is given for four cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, Objective Response Rate, is measured for up to 24 months.
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NCT07098988
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Recruiting
PHASE2Ages 18+InterventionalTreatmentCatalYm GmbH
~107 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:VisugromabMatching placebo for visugromabPembrolizumab 200 mg Q3WPemetrexed 500 mg/m^2Carboplatin AUC 5
At a glance
Recruiting sites
42 of 42 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate
Measured over up to 24 months
Conditions
Where it's being run
42 sites across 28 statesAndalusia4
North Rhine-Westphalia3
Italy3
Romania3
Madrid3
Poland2
Catalonia2
Spain2
Study leadership
- Felix Lichtenegger, MD · STUDY_DIRECTOR · CatalYm GmbH
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.
Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
Measurable disease determined by the local site Investigator/radiology by their assessment per RECIST v1.1.
Have not received prior systemic treatment for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1/PD L1 directed CPI therapy.
Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated.
Availability of a tissue/histological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted.
Age ≥ 18 years on the day of signing the informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Adequate organ function (bone marrow, hepatic, renal function and coagulation).
Exclusion
Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage).
Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within \< 3 months prior to planned treatment start).
Major surgery (defined as a surgery which requires general anesthetic and/or involves opening of body cavities), within 4 weeks of the first dose of study drug.
Received potentially curative radiation therapy to the lung that is \> 30 Gy within 6 months prior to the first dose of study drug.
Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug.
Expected to require any other form of antineoplastic therapy while on trial.
Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction.
Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
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 with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions.
Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri/myocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start.
Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.
Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.
What this trial measures
- Objective Response Rateup to 24 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