Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)
Summary
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).
Arms & interventions
- BiologicalVisugromab RDE (recommended dose for expansion)
Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
- BiologicalVisugromab 6mg/kg
Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
- BiologicalNivolumab
Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
- OtherPlacebo Saline Infusion
Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
- DrugDocetaxel
Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
Outcome measures
Primary
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
Secondary
Adverse Events
Time frame: up to 60 months
CR rate
Time frame: up to 36 months
PR rate
Time frame: up to 36 months
ORR rate
Time frame: up to 36 months
DOR
Time frame: up to 36 months
TTR
Time frame: up to 36 months
PFS
Time frame: up to 60 months
OS
Time frame: up to 60 months
Participant weight course over time
Time frame: up to 39 months
Maximum Concentration (Cmax) of visugromab
Time frame: up to 36 months
Minimum Concentration (Cmin) visugromab
Time frame: up to 36 months
Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
Time frame: up to 39 months
Eligibility criteria
Study locations (4)
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, Alabama, 35294-3300
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
NYU Longone Health
New York, New York, 10016
Duke University Medical Center
Durham, North Carolina, 27710