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
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborator: G1 Therapeutics, Inc.
• Treatments: Carboplatin; Etoposide; Topotecan

Criteria

Inclusion Criteria:

1. Male or female of ≥ 18 years old;

2. Histology or cytology diagnosed extensive-stage small cell lung cancer ( ES-SCLC ) :

3. Patients who plan to receive carboplatin combined with etoposide: naïve with systemic treatment (such as chemotherapy or combined immunotherapy) in the past

4. Patients planning to receive topotecan : previously received 1/2 line chemotherapy or combined immunotherapy except for topotecan.

5. At least one measurable lesion without radiotherapy that meets RECIST1.1 standard;

6. Hemoglobin ≥ 90 g/L ;

7. Neutrophil count ≥ 1.5 × 109 /L ;

8. Platelet count ≥100 × 109 /L ;

9. Creatinine ≤ 15 mg /L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula ) ;

10. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ;

11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 × ULN (patients with liver metastases) ;

12. Albumin ≥ 30 g/L ;

13. ECOG PS score:0-2 ;

14. Expected survival time ≥ 3 months ;

15. Contraception :

16. 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 ;

17. 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.

18. Understand and sign the informed consent form.

Exclusion Criteria:

1. Symptomatic brain metastases that require local radiotherapy or hormone therapy;

2. 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;

3. Uncontrolled ischemic heart disease or congestive heart failure with clinically significance (NYHA Class III or IV) ;

4. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment ;

5. Severe active infection;

6. Potential inadequate compliance from psychological or other social factors;

7. Other uncontrolled severe chronic disease or condition, which considered by Investigator as unsuitable for study participation;

8. Known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive);

9. Received radiotherapy within 2 weeks before enrollment ;

10. Received cytotoxic or investigational drug treatment within 4 weeks, or non-cytotoxic anti-tumor treatment within 2 weeks before enrollment;

11. 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;

12. Recovery from previous toxicity of anti-tumor treatments to Level 0 or 1 (except for hair loss);

13. Allergy to the study drugs or any of their components (Trilaciclib, etoposide, carboplatin, topotecan);

14. Unable to act independently by legal restrictions or in the legal sense;

15. Women who are pregnant or breastfeeding ;

16. Other patients who are considered unsuitable to participate in the study. -