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Taxane
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4) (PRESERVE 4 Trial)
Phase 2
Waitlist Available
Research Sponsored by G1 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to the date of documented radiologic pd per recist v1.1 or date of death regardless of the cause, whichever comes first, for those who had the events. otherwise, pfs is calculated per censoring rules, assessed up to 30 months.
Summary
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.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization to the date of documented radiologic pd per recist v1.1 or date of death regardless of the cause, whichever comes first, for those who had the events. otherwise, pfs is calculated per censoring rules, assessed up to 30 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to the date of documented radiologic pd per recist v1.1 or date of death regardless of the cause, whichever comes first, for those who had the events. otherwise, pfs is calculated per censoring rules, assessed up to 30 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Secondary study objectives
Effect of trilaciclib on Progression Free Survival (PFS) compared with placebo
Effect of trilaciclib on chemotherapy dosing compared with placebo
Effect of trilaciclib on hospitalizations due to chemotherapy induced myelosuppression compared with placebo
+5 moreSide effects data
From 2019 Phase 1 & 2 trial • 122 Patients • NCT0249977058%
Fatigue
42%
Neutropenia
42%
Anemia
42%
Leukopenia
42%
Nausea
42%
Alopecia
33%
Vomiting
33%
Headache
33%
Constipation
25%
Thrombocytopenia
25%
Pyrexia
25%
Diarrhea
17%
Dizziness
17%
Arthralgia
17%
Dyspnea
17%
Chills
17%
Edema peripheral
17%
Insomnia
8%
Bone pain
8%
Neck pain
8%
Cough
8%
Hyperglycemia
8%
Pneumonia
8%
Myocardial infarction
8%
Blood creatinine increased
8%
Infusion related reaction
8%
Weight decreased
8%
Asthenia
8%
Anxiety
8%
Night sweats
8%
Back pain
8%
Dehydration
8%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
Part 2: Placebo
Part 2: Trilaciclib 240 mg/m^2
Part 1: Cohort 2 Trilaciclib 240mg/m^2
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: trilaciclib + docetaxelExperimental Treatment2 Interventions
Patients will receive trilaciclib administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Group II: placebo + docetaxelPlacebo Group2 Interventions
Patients will receive placebo administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trilaciclib
2015
Completed Phase 4
~400
Docetaxel
1995
Completed Phase 4
~6550
Find a Location
Who is running the clinical trial?
G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,281 Total Patients Enrolled
Clinical ContactStudy DirectorG1 Therapeutics, Inc.
10 Previous Clinical Trials
1,305 Total Patients Enrolled