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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
131
Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, Alabama, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGNYU Langone Hospital - Long Island
Mineola, New York, United States
RECRUITINGNYU Longone Health
New York, New York, United States
Objective Response Rate (ORR)
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
Time frame: up to 36 months
Adverse Events
Incidence, type and severity of adverse events, treatment emergent adverse events, treatment-related adverse events and serious adverse events
Time frame: up to 60 months
CR rate
Complete response rate
Time frame: up to 36 months
PR rate
Partial response rate
Time frame: up to 36 months
ORR rate
Overall response rate
Time frame: up to 36 months
DOR
Duration of response
Time frame: up to 36 months
TTR
Time-to-respond
Time frame: up to 36 months
PFS
Progression-free survival
Time frame: up to 60 months
OS
Overall survival
Time frame: up to 60 months
Participant weight course over time
Participant weight course over time
Time frame: up to 39 months
Maximum Concentration (Cmax) of visugromab
Cmax is the maximum observed serum concentration of visugromab.
Time frame: up to 36 months
Minimum Concentration (Cmin) visugromab
Cmin is the minimum observed serum concentration of visugromab
Time frame: up to 36 months
Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
NSCLC-SAQ is a participant reported outcome with seven (7) items assessing five (5) symptom domains of NSCLC: cough, fatigue, pain, dyspnea, and appetite. Each item is scored individually from 0 ("None/Never") to 4 ("Severe/Always"). The total score is calculated by summing domain scores, which are derived as follows: single-item domains (cough, dyspnea, appetite) use the item score; fatigue uses the mean of two items (or one if only one is answered); pain uses the highest score of two items (or one if only one is answered). The total score ranges from 0-20, with higher scores indicating more severe symptoms. If any domain score is missing, a total score is not computed
Time frame: up to 39 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Duke University Medical Center
Durham, North Carolina, United States
RECRUITINGHospital Esslingen GmbH
Esslingen am Neckar, Baden-Wurttemberg, Germany
RECRUITINGThorax Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGUniversity Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, Internal Oncology, Stem Cell Therapies, Hepatology, Infectiology, Psychosomatics and Rheumatology/ Clinical Immunology
Würzburg, Bavaria, Germany
RECRUITINGEvangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative Medicine Johannesstift
Bielefeld, North Rhine-Westphalia, Germany
RECRUITINGClinics Essen-Mitte
Essen, North Rhine-Westphalia, Germany
RECRUITING...and 24 more locations