This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial evaluating the effect of trilaciclib on overall survival when administered prior to docetaxel in patients with metastatic NSCLC treated in the 2nd or 3rd line setting.
Patients must have documented disease progression during or after one or two lines of systemic therapy for recurrent or metastatic NSCLC. Prior treatment must have included, either in the same line or as separate lines of therapy: 1) a maximum of 1 line of platinum-containing chemotherapy for recurrent/metastatic disease and 2) a maximum of 1 line of a locally approved/authorized programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) containing regimen for recurrent/metastatic disease. Patients will be randomly assigned (1:1) to receive trilaciclib or placebo intravenously (IV) prior to docetaxel on Day 1 of each 21-day cycle. The study will include a screening phase, a treatment phase and a survival follow-up phase. The patient may continue to receive treatment on study until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first. This study was terminated by the Sponsor for non-safety reasons. At the time of study termination, 10 patients had been screened, 7 were randomized, and 2 of the 7 had discontinued from the study. In addition, it was decided that there would be no statistical analyses of the efficacy or safety data due to the limited number of patients treated (N=7).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel administered IV on Day 1 of each 21-day cycle.
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
To assess the effects of trilaciclib administered prior to docetaxel compared with placebo administered prior to docetaxel on occurrence and severity of adverse events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, study treatment discontinuation due to adverse events (AEs), and trilaciclib adverse events of special interest (AESI) in patients with metastatic NSCLC receiving docetaxel in the second or third line.
Time frame: Time from date of first dose of trilaciclib/placebo and docetaxel through 30 days following the last dose of trilaciclib/placebo and docetaxel, assessed up to 9 months and 2 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Innovative Clinical Research Institute - Oncology
Whittier, California, United States
Mid-Florida Hematology Oncology
Orange City, Florida, United States
Indiana University Health Goshen Cancer Center
Goshen, Indiana, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, United States
Summit Medical Group
Florham Park, New Jersey, United States
Regional Cancer Car Associates, LLC
Little Silver, New Jersey, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
...and 2 more locations