A study to evaluate the effect of trilaciclib on overall survival in patients with metastatic non-small cell lung cancer receiving docetaxel

Phase 1

Conditions: Metastatic 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]

Registration Number: EUCTR2021-000186-32-ES

Lead Sponsor: G1 Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 146

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 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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 146
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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 (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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials