Phase 3 Study Evaluating Efficacy Safety and Pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin Combined With Etoposide or Topotecan

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    92
  • sponsor
    Jiangsu Simcere Pharmaceutical Co., Ltd.
Updated on 17 September 2021

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 Carboplatin combined with Etoposide or Topotecan The study consists of 2 parts: Part 1: safety run-in and pharmacokinetics evaluation of 12 ES-SCLC patients (6 each for first line and second/third line ES-SCLC patients); Part 2: randomized, double-blind, placebo-controlled efficacy confirmation study of 80 ES-SCLC patients (stratified by first line and second/third line ES-SCLC, ECOG PS [0-1 vs 2] and brain metastases.

The study includes screening period, treatment period, safety follow-up and survival follow-up.

Details
Condition Extensive Stage Small Cell Lung Cancer, small cell lung cancer, extensive stage
Treatment Trilaciclib
Clinical Study IdentifierNCT04902885
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female of 18 years old
Histology or cytology diagnosed extensive-stage small cell lung cancer ( ES-SCLC )
Patients who plan to receive carboplatin combined with etoposide: nave with systemic treatment (such as chemotherapy or combined immunotherapy) in the past
Patients planning to receive topotecan : previously received 1/2 line chemotherapy or combined immunotherapy except for topotecan
At least one measurable lesion without radiotherapy that meets RECIST1.1 standard
Hemoglobin 90 g/L
Neutrophil count 1.5 109 /L
Platelet count 100 109 /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 (patients with liver metastases)
Albumin 30 g/L
ECOG PS score:0-2
Expected survival time 3 months
Contraception
Women: Women with potential fertility must have a negative serum pregnancy test result at Screening, and take reliable contraceptive measures from signing informed consent to 3 months after the last administration
Male: If a female partner has potential fertility, reliable contraceptive measures must be taken after signing the informed consent to 3 months after the last administration
Understand and sign the informed consent form

Exclusion Criteria

Symptomatic brain metastases that require local radiotherapy or hormone therapy
Other history of malignant cancer, except for: (1) clinically cured basal cell or squamous cell tumors; (2) curable: a) cervical cancer, B) prostate cancer, C) superficial bladder cancer; or ( 3 ) any solid tumor that it is clinically cured for 3 years or above
Uncontrolled ischemic heart disease or congestive heart failure with clinically significance (NYHA Class III or IV)
Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment
Severe active infection
Potential inadequate compliance from psychological or other social factors
Other uncontrolled severe chronic disease or condition, which considered by Investigator as unsuitable for study participation
Known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive)
Received radiotherapy within 2 weeks before enrollment
Received cytotoxic or investigational drug treatment within 4 weeks, or non-cytotoxic anti-tumor treatment within 2 weeks before enrollment
For Part 1 patients, concomitant administration of strong or moderate inducer of CYP3A4 within 4 weeks before study drug, or strong inhibitor of CYP3A4 within 2 weeks before study drug
Recovery from previous toxicity of anti-tumor treatments to Level 0 or 1 (except for hair loss)
Allergy to the study drugs or any of their components (Trilaciclib, etoposide, carboplatin, topotecan)
Unable to act independently by legal restrictions or in the legal sense
Women who are pregnant or breastfeeding
Other patients who are considered unsuitable to participate in the study. -
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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