Status:
COMPLETED
Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborating Sponsors:
G1 Therapeutics, Inc.
Conditions:
Extensive-stage Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Randomized, double-blind, placebo-controlled, multi-center Phase 3 study evaluating efficacy, safety and pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving ...
Detailed Description
This is a multi-center Phase 3 clinical trial with an open-label single-arm safety run-in and PK evaluation part and a randomized double-blind, placebo controlled part in patients with ES-SCLC to eval...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, male or female;
- Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC):
- Patients scheduled to receive carboplatin plus etoposide regimen: no prior systemic therapy (eg, chemotherapy or combined with immunotherapy);
- Patients scheduled to receive topotecan regimen: previously received 1/2 lines of chemotherapy or combined immunotherapy but not topotecan.
- Presence of at least one radiation-naïve measurable lesion according to RECIST 1.1 criteria;
- Hemoglobin ≥ 90 g/L;
- Neutrophil count ≥ 1.5 × 10\^9/L;
- Platelet count ≥ 100 × 10\^9/L;
- Creatinine ≤ 15 mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula);
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 × ULN (for patients with liver metastases);
- Albumin ≥ 30 g/L;
- ECOG PS score 0 - 2;
- Expected survival time ≥ 3 months;
- Contraception:
- Females: All females of childbearing potential must have a negative serum pregnancy test at screening and must use reliable contraception from signing of informed consent through 3 months after the last dose; Male: Female partners of childbearing potential must use reliable contraception from signing the informed consent until 3 months after the last dose;
- Understand and sign informed consent
Exclusion
- Symptomatic brain metastases requiring local radiotherapy or hormonal therapy;
- History of other malignancies, with the following exceptions: (1) clinically cured cutaneous basal cell or squamous cell tumors; (2) cured a) cervical cancer, b) prostate cancer, c) superficial bladder cancer; or (3) other solid tumors with a clinical cure time of more than 3 years;
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV);
- Stroke or cardiovascular or cerebrovascular event within 6 months prior to enrollment;
- Severe active infection;
- Psychological or other social factors causing insufficient trial compliance;
- Other uncontrolled serious chronic diseases or conditions that, in the opinion of the investigator, would make participation in the trial inappropriate;
- Known HIV infection, active hepatitis B (defined as positive HBV DNA), and hepatitis C (positive HCV RNA);
- Radiation therapy within 2 weeks prior to enrollment;
- Patients who have received cytotoxic drug therapy or investigational drug therapy within 4 weeks before enrollment, or non-cytotoxic anti-tumor drug therapy within 2 weeks;
- Subjects in the first part of the study should not take strong or moderate inducers of CYP3A4 concomitantly within 4 weeks before taking the study drug, and strong inhibitors of CYP3A4 concomitantly within 2 weeks before taking the study drug;
- Toxicity from prior anticancer therapy has not recovered to Grade 0 or 1 (except alopecia);
- Hypersensitivity to the study drug (Trilaciclib, etoposide, carboplatin, topotecan) or components thereof;
- Persons who are unable to act independently due to legal restriction or legal sense;
- Pregnant or lactating women;
- Not suitable for participating in this study in the investigator 's opinion.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04902885
Start Date
May 25 2021
End Date
December 31 2022
Last Update
July 10 2024
Active Locations (1)
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1
Jilin Cancer Hopspital
Changchun, China