← Back to Search

Taxane

Trilaciclib for Lung Cancer (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.
Awards & highlights

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
  • Lung Cancer
  • Non-Small Cell Lung Cancer

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Secondary outcome measures
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 more

Side effects data

From 2019 Phase 1 & 2 trial • 122 Patients • NCT02499770
58%
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%
Chills
17%
Arthralgia
17%
Dyspnea
17%
Edema peripheral
17%
Insomnia
8%
Cough
8%
Hyperglycemia
8%
Neck pain
8%
Bone pain
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
~210
Docetaxel
1995
Completed Phase 4
~5620

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
~2 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top