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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-000186-32
    Sponsor's Protocol Code Number:G1T28-210
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-000186-32
    A.3Full title of the trial
    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)
    Badanie kliniczne fazy II prowadzone metodą podwójnie ślepej próby z zastosowaniem randomizacji porównujące trilacyklib z placebo u chorych na przerzutowego niedrobnokomórkowego raka płuca (NSCLC) leczonych docetakselem w drugiej / trzeciej linii (badanie PRESERVE 4).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of trilaciclib on overall survival in patients with metastatic non-small cell lung cancer receiving docetaxel
    Badanie mające na celu ocenę wpływu trilacyklibu na przeżycie całkowite u pacjentów z przerzutowym niedrobnokomórkowym rakiem płuca otrzymujących docetaksel
    A.4.1Sponsor's protocol code numberG1T28-210
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04863248
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorG1 Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportG1 Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationG1 Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 110341
    B.5.3.2Town/ cityResearch Triangle Park, North Carolina
    B.5.3.3Post code27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number19192139835
    B.5.5Fax number19197415830
    B.5.6E-mailclinicalinfo@g1therapeutics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name COSELA
    D.2.1.1.2Name of the Marketing Authorisation holderG1 Therapeutics, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtrilaciclib dihydrochloride
    D.3.9.1CAS number 1977495-97-8
    D.3.9.2Current sponsor codeG1T28
    D.3.9.3Other descriptive nameG1T28 di-HCl, G1T28-1, CGB3RG-28-1, TRILA-IV, TRILA Di-HCl, trilaciclib dihydrochloride dihydrate
    D.3.9.4EV Substance CodeSUB181989
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Non small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of trilaciclib on overall survival compared with placebo
    E.2.2Secondary objectives of the trial
    To assess the effect of trilaciclib on progression-free survival compared with placebo
    To assess the effect of trilaciclib on other anti-tumor endpoints compared with placebo
    To assess the effects of trilaciclib on the neutrophil lineage compared with placebo
    To assess the effects of trilaciclib on the red blood cell lineage compared with placebo
    To assess the effects of trilaciclib on the platelet lineage compared with placebo
    To assess the effects of trilaciclib on chemotherapy dosing compared with placebo
    To assess the effects of trilaciclib on hospitalizations due to chemotherapy-induced myelosuppression compared with placebo
    To assess the safety and tolerability of trilaciclib compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal 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 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
    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 platinum-based 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
    b) Absolute neutrophil count (ANC) ≥1.5 × 10^9/L
    c) Platelet count ≥100 × 10^9/L
    d) Total bilirubin ≤ upper limit of normal (ULN)
    e) AST/ALT <1.5 × ULN if alkaline phosphatase >2.5 × ULN
    f) If alkaline phosphatase <2.5 × ULN then AST, ALT <2.5 x ULN in the absence of liver metastasis or <5 × ULN in the presence of liver metastasis
    g) Estimated glomerular filtration rate ≥30 mL/minute/1.73m2
    7. Resolution of nonhematologic toxicities per National Cancer Institute Common Terminology Criteria Version 5.0 (NCI-CTCAE) from prior therapy or surgical procedures to ≤ Grade 1 or baseline (except alopecia)
    8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
    E.4Principal 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)
    11. History of interstitial lung disease (ILD)
    12. Clinically significant (i.e., active) cardiovascular disease at the time of signing the informed consent; for example cerebrovascular accidents (≤ 6 months before the first dose of trilaciclib/placebo), myocardial infarction (≤ 6 months before the first dose of trilaciclib/placebo), unstable angina, serious cardiac arrythmia requiring medication, or uncontrolled symptomatic congestive heart failure [Class II or higher as defined by the New York Heart Association [NYHA] functional classification system])
    13. Known serious active infection including but not limited to human immunodeficiency virus (HIV) (e.g., viral load indicative of HIV, HIV 1/2 antibodies), Hepatitis B (e.g., HBsAg reactive or HBV DNA detected), Hepatitis C (e.g., HCV RNA [quantitative] is detected) or tuberculosis
    14. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation
    15. Receipt of any low-dose systemic chemotherapeutic agent (e.g., low-dose methotrexate for rheumatoid arthritis) administered for a nononcologic purpose within 3 weeks prior to the first dose of trilaciclib/placebo
    16. Receipt of any live attenuated vaccines within 4 weeks prior to first dose of study treatment or anticipation that such a vaccine will be required during the study treatment period
    17. Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80 or any excipients of trilaciclib
    18. Pregnant or lactating women
    19. Legal incapacity or limited legal capacity
    20. Other uncontrolled serious chronic disease or psychiatric condition that in the Investigator’s opinion could affect patient safety, compliance, or follow-up in the protocol
    21. Concurrent participation in any other interventional clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival in the intent-to-treat population
    E.5.1.1Timepoint(s) of evaluation of this end point
    time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)
    E.5.2Secondary end point(s)
    o Progress-free survival in intent-to-treat population
    o Objective response rate
    o Duration of objective response
    o Duration of severe (Grade 4) neutropenia in Cycle 1
    o Occurrence of severe (Grade 4) neutropenia
    o Occurrence of febrile neutropenia AEs
    o Occurrence of granulocyte colony-stimulating factor administration
    o Occurrence of Grade 3 or 4 decreased hemoglobin laboratory values
    o Red blood cells transfusions on or after Week 5 (occurrence and number of transfusions)
    o Occurrence of erythropoiesis stimulating agent administration
    o Occurrence of Grade 3 or 4 decreased platelet count laboratory values
    o Platelet transfusions (occurrence and number of transfusions)
    o All-cause dose reductions (occurrence and number of reductions)
    o All-cause cycle delays (occurrence and number of delays)
    o Occurrence and number of hospitalizations due to chemotherapy-induced myelosuppression
    o Occurrence and severity of AEs by NCI-CTCAE v5
    o Study treatment discontinuation due to AEs
    o Changes in laboratory parameters (hematology, chemistry), vital signs and ECG parameters
    o Grade 3 or 4 abnormalities in laboratory parameters
    o Trilaciclib AEof special interests
    o Chemotherapy infusion interruptions
    o Relative dose intensity for docetaxel
    E.5.2.1Timepoint(s) of evaluation of this end point
    o Time from randomization to disease progression using RECIST v1.1 or death due to any cause, whichever occurs first; for patients without disease progression or death, Progress-free survival will be calculated per censoring rules
    o Percentage of patients with confirmed complete response and partial response per RECIST v1.1
    o Other end points: thorough the study as per the schedule of assessments in the protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers, patient reported outcomes
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    France
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV or study-related phone-call. The end of study is event driven. That is, the study will continue until the targeted number of deaths is observed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 146
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 146
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of study treatment on the study, patients will receive treatment as determined by their healthcare provider
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-02-02
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