| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04902885 | Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients | PHASE3 | COMPLETED | 95 | — | — | May 25, 2021 | Dec 31, 2022 | Jul 10, 2024 | 1 | China |
AUC0-inf of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
DSN in Cycle 1 was defined as the number of days from the date of the first ANC value \< 0.5 x 10\^9/L in Cycle 1 to the date of the first ANC value ≥ 0.5 x 10\^9/L. The date of the first ANC value ≥ 0.5 x 10\^9/L should meet the following requirements: (1) occurred after the ANC value was \< 0.5 x 10\^9/L, and (2) there were no other ANC values \< 0.5 x 10\^9/L between this date and the end of Cycle 1 (otherwise, if this patient entered Cycle 2, it was counted as Day 1 of Cycle 2). DSN in Cycle 1 was scored as 0 if the patient did not experience any SN during Cycle 1.
Cmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. For estimation of Cmax, a concentration that was below the limit of quantification (BLQ) was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted.
| Arm | Type | Description |
|---|---|---|
| Part I ( Safety run-in and PK Evaluation); Trilaciclib Group | ACTIVE_COMPARATOR | 12 patients( 6 patients are first line, 6 patients are second or third line) recieved Trilaciclib(240mg/m\^2) plus chemotherapy. |
| Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | ACTIVE_COMPARATOR | 41 patients received trilaciclib(240mg/m\^2) plus chemotherapy |
| Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | PLACEBO_COMPARATOR | 42 patients received placebo plus chemotherapy |
| Name | Type | Description |
|---|---|---|
| Trilaciclib, carboplatin, etoposide,or Topotecan | DRUG | Trilaciclib plus carboplatin, etoposide for first line patients ;Trilaciclib plus Topotecan for second or third line patients |
| placebo, carboplatin, etoposide,or Topotecan | DRUG | placebo plus carboplatin, etoposide for first line patients ;placebo plus Topotecan for second or third line patients |
Inclusion Criteria: 1. Age ≥ 18 years, male or female; 2. 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); ...