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

This is an interventional treatment trial for Extensive-stage Small-cell Lung Cancer Read More

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. -