A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib versus Placebo in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated with Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4) - PRESERVE 4

G1 Therapeutics Inc.0 sites146 target enrollmentOctober 19, 2021

ConditionsMetastatic Non small cell lung cancer MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsDocetaxel AqVida

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Non small cell lung cancer
Sponsor: G1 Therapeutics Inc.
Enrollment: 146
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 19, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

G1 Therapeutics Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Age \>\=18 years of age at the time of signing the informed consent
•2\. Histologically or cytologically confirmed metastatic NSCLC (squamous or nonsquamous) with no known actionable driver mutations (ex. EGFR, ROS1, ALK):
•o Patients must have had documented disease progression during or after 1 or 2 lines of systemic treatment for recurrent or metastatic disease
•o Two components of treatment must have been received in the same line or as separate lines of therapy: (i) a maximum of 1 line of platinumcontaining chemotherapy regimen for recurrent/metastatic disease, and (ii) a maximum of 1 line of a locally approved/authorized PD\-1/PD\-L1 mAb containing regimen for recurrent/metastatic disease
•o Maintenance therapy following platinum doublet\-based chemotherapy is not considered as a separate line of therapy. Maintenance therapy is defined as therapy given within 42 days after the last dose of platinumbased chemotherapy in patients with ongoing clinical benefit (complete response \[CR], partial response \[PR] or stable disease \[SD]).
•3\. Measurable or non\-measurable disease per RECIST v1\.1
•4\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
•5\. A formalin\-fixed paraffin\-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting NSCLC must be available to send to the Sponsor, within the specified timeframe, for planned retrospective biomarker analyses
•6\. Adequate organ function defined by the following laboratory values:
•a) Hemoglobin \>\=9\.0 g/dL in the absence of red blood cell transfusion or erythropoiesis stimulating agent administration within 14 days prior to first dose of trilaciclib/placebo

Exclusion Criteria

•1\. Prior therapy with docetaxel
•2\. Any contraindication to the administration of docetaxel at the discretion of the investigator
•3\. Mixed NSCLC/SCLC, or lung tumors whose predominant histology is sarcomatoid, or neuroendocrine
•4\. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate\-specific antigen (PSA) persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo
•5\. Any radiotherapy within 2 weeks prior to the first dose of trilaciclib/placebo
•6\. Presence of central nervous system (CNS) metastases requiring immediate treatment with radiation therapy or steroids (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo)
•7\. Presence of leptomeningeal disease
•8\. Significant third\-space fluid retention (ex. ascites or pleural effusion) not amenable to required repeat drainage
•9\. QT corrected using Fridericia's formula (QTcF) interval \>480 msec at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF \>500 msec
•10\. Symptomatic peripheral neuropathy (\>\= Grade 2 NCI\-CTCAE v5\.0\)