Study on Visugromab with Immunochemotherapy for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Sponsor: CatalYm GmbH
ClinicalTrials ID:NCT07098988
This clinical trial is testing a new treatment combination using Visugromab with standard immunochemotherapy for patients newly diagnosed with metastatic non-squamous NSCLC. The study aims to evaluate the safety and effectiveness of this combination in controlling the cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to explore the effects of a new drug, Visugromab, when combined with standard immunochemotherapy (Pembrolizumab, Pemetrexed, and Carboplatin) for treating patients with newly diagnosed metastatic non-squamous non-small cell lung cancer (NSCLC). The trial is divided into three parts: an initial safety phase, followed by a randomized trial with two treatment groups. After treating 15 participants with Visugromab, researchers will conduct an interim analysis to assess safety and early results before continuing with the rest of the participants.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with stage IV non-squamous NSCLC confirmed by lab tests.
- No mutations that require specific targeted treatments.
- Have measurable cancer as determined by medical imaging.
- Have not received previous treatment for advanced/metastatic NSCLC, except if prior treatment was completed over a year ago and did not include certain immunotherapies.
- Have a PD-L1 test result from a biopsy after any previous treatment, with specific conditions for enrollment based on PD-L1 levels.
- Provide a tissue sample for research purposes and consent to its use.
- Be 18 years or older.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function based on blood and other tests.
Exclusion Criteria
- Have a type of lung cancer that is predominantly squamous or neuroendocrine, or have small cell lung cancer elements.
- Have had major tissue injury or organ failure within the last 3 months.
- Have had major surgery within 4 weeks before starting the study.
- Have received high-dose radiation therapy to the lung within 6 months before starting the study.
- Have received any radiation therapy for symptoms within 28 days before starting the study.
- Need other cancer treatments while on the trial.
- Have active inflammatory bowel disease or other serious gastrointestinal conditions.
- Have had another cancer unless treated and disease-free for 5 years.
- Have active cancer spread to the brain or spinal cord unless stable and monitored.
- Have certain heart conditions or risk factors, such as recent heart attack or uncontrolled heart issues.
- Have an active autoimmune disease requiring treatment in the last 3 months.
- Are taking metformin for type II diabetes.
- Have lung disease or a history of lung inflammation requiring steroids.
- Are pregnant, breastfeeding, or planning to conceive during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294-2936 | Birmingham | Alabama |
| USC Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Yale Cancer Center | 06519 | New Haven | Connecticut |
| Duke University Medical Center | 27710 | Durham | North Carolina |
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