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New treatment option for Metastatic Non-Squamous Non-Small Cell Lung Cancer
Official title Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
ClinicalTrials.gov ID: NCT07098988
What this study is testing
What is Visugromab?
Visugromab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic non-squamous non-small cell lung cancer.
Also referred to as CTL-002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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...
You likely can't join if
- Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the...
- Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed...
- 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...
- 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.
See the full eligibility criteria
- Main
- 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...
- 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...
- 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...
- 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). Main
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Charleston, South Carolina, United States
- Heidelberg, Baden-Wurttemberg, Germany
- Würzburg, Bavaria, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Moers, North Rhine-Westphalia, Germany
- Großhansdorf, Schleswig-Holstein, Germany
- Meldola, Forli, Italy
- Aviano, Italy
- Ravenna, Italy
- Rome, Italy
- Poznan, Poland
- Prabuty, Poland
- Craiova, Dolj, Romania
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; New York, New York, United States; Durham, North Carolina, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.