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Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

RecruitingPhase 2Ages 18 Years - anyAllCatalYm GmbH
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In plain words

What the trial is, and whether it could suit you

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. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Main Inclusion Criteria: * 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 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment. * 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 Exclusion Criteria: * 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 immunosuppressive drugs). * Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
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What it tests

  • Visugromab RDE (recommended dose for expansion)
  • Visugromab 6mg/kg
  • Nivolumab
  • Placebo Saline Infusion
  • Docetaxel
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Where

36 sites
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
NYU Langone Hospital - Long Island
Mineola, United States
NYU Longone Health
New York, United States
Duke University Medical Center
Durham, United States
Hospital Esslingen GmbH
Esslingen am Neckar, Germany
Thorax Clinic Heidelberg
Heidelberg, Germany
University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology
Würzburg, Germany

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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