Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)

NCT04863248 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: G1T28-2102021-000186-32
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Metastatic Non-Small Cell Lung Cancer; NSCLC; Lung Cancer

Keywords

Trilaciclib; Lung Cancer; Non-Small Cell Lung Cancer; PRESERVE 4; CDK 4/6 Inhibitor; cyclin-dependent kinase 4/6 inhibitor; Preserve; NSCLC; solid tumors; chemotherapy; metastatic; myeloprotection; advanced; stage 4; lung; docetaxel; COSELA; G1T28

Outcome Measures

Primary Outcomes (1)

• 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 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.

Study Arms (2)

trilaciclib + docetaxel

EXPERIMENTAL

Patients will receive trilaciclib administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle.

Drug: Trilaciclib; Drug: Docetaxel

placebo + docetaxel

PLACEBO COMPARATOR

Patients will receive placebo administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle.

Drug: Placebo; Drug: Docetaxel

Interventions

Trilaciclib DRUG

Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.

Also known as: COSELA, G1T28

trilaciclib + docetaxel

Placebo DRUG

Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.

Also known as: 0.9% sodium chloride, 5% Dextrose in water (D5W)

placebo + docetaxel

Docetaxel DRUG

Docetaxel administered IV on Day 1 of each 21-day cycle.

Also known as: Taxotere, Docefrez

placebo + docetaxel; trilaciclib + docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years of age at the time of signing the informed consent.
• Histologically or cytologically confirmed metastatic NSCLC (squamous or nonsquamous) with no known actionable driver mutations (eg, EGFR, ROS1, ALK).
• Patients must have had documented disease progression during or after 1 or 2 lines of systemic treatment for recurrent or metastatic disease.
• 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 platinum-containing 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.
• 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 platinum-based chemotherapy in patients with ongoing clinical benefit (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]).
• Measurable or non-measurable disease per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• 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.
• Adequate organ function defined by the normal laboratory values.

You may not qualify if:

• Prior therapy with docetaxel.
• Any contraindication to the administration of docetaxel at the discretion of the investigator.
• Mixed NSCLC/SCLC, or lung tumors whose predominant histology is sarcomatoid, or neuroendocrine.
• 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.
• Any radiotherapy within 2 weeks prior to the first dose of trilaciclib/placebo.
• 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).
• Presence of leptomeningeal disease.
• Significant third-space fluid retention (eg, ascites or pleural effusion) not amenable to required repeat drainage.
• QT corrected using Fridericia's formula (QTcF) interval \>480 msec at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF \>500 msec.
• Symptomatic peripheral neuropathy.
• History of interstitial lung disease (ILD).
• Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation.

Sponsors & Collaborators

• G1 Therapeutics, Inc.: lead

Study Sites (12)

Ironwood Cancer & Research Centers

Phoenix, Arizona, 85028, United States

Location

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

Desert Hematology Oncology Medical Group, Inc

Rancho Mirage, California, 92270, United States

Location

Innovative Clinical Research Institute - Oncology

Whittier, California, 90602, United States

Location

Mid-Florida Hematology Oncology

Orange City, Florida, 32763, United States

Location

Indiana University Health Goshen Cancer Center

Goshen, Indiana, 46526, United States

Location

St. Louis Cancer Care, LLP

Bridgeton, Missouri, 63044, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

Regional Cancer Car Associates, LLC

Little Silver, New Jersey, 07739, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Millennium Oncology

Houston, Texas, 77090, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis

Interventions

trilaciclib; Sodium Chloride; Glucose; Water; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

This study was terminated earlier than initially proposed by the Sponsor for non-safety related reasons; only 7 patients were randomized and treated. Therefore, only limited safety summary tables were generated, and no efficacy analyses were conducted.

Results Point of Contact

• Title: Clinical Trial Info
• Organization: G1 Therapeutics, Inc

clinicalinfo@g1therapeutics.com

919-213-9835

Study Officials

• Clinical Contact

  G1 Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 28, 2021
• Study Start: April 30, 2021
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-01

Locations

US (12)