BridgeMD
New treatment option for Metastatic Non-Squamous Non-Small Cell Lung Cancer
Official title Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
ClinicalTrials.gov ID: NCT07246863
What this study is testing
What is Visugromab RDE (recommended dose for expansion)?
Visugromab RDE (recommended dose for expansion) 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) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 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
- Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available...
- Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor...
- Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
You likely can't join if
- Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
- Participants must not have a prior malignancy requiring treatment.
- Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with...
- Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e...
- Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current...
See the full eligibility criteria
- Main
- Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
- Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12...
- Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
- Participants must have life expectancy of at least 3 months as assessed by the Investigator.
- Participants must have ECOG performance status ≤1. Main
- Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
- Participants must not have a prior malignancy requiring treatment.
- Participants must not have a 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 must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or...
- Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Esslingen am Neckar, Baden-Wurttemberg, Germany
- Würzburg, Bavaria, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
- Moers, North Rhine-Westphalia, Germany
- Forlì, Emilia-Romagna, Italy
- Aviano, Friuli Venezia Giulia, Italy
- Rome, Lazio, Italy
- Ravenna, Italy
- Craiova, Dolj, Romania
- Sibiu, Sibiu County, Romania
- Timișoara, Timiș County, Romania
- Jaén, Andalusia, Spain
- Málaga, Andalusia, Spain
- Santiago de Compostela, Galicia, Spain
- Logroño, La Rioja, Spain
+ 4 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 York, New York, United States; Durham, North Carolina, United States; Esslingen am Neckar, Baden-Wurttemberg, Germany; Würzburg, Bavaria, Germany and 18 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.