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Trilaciclib, carboplatin, etoposide,or Topotecan

Phase 3

Extensive-stage Small-cell Lung Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jul 10, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04902885Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer PatientsPHASE3 COMPLETED 95May 25, 2021Dec 31, 2022Jul 10, 20241 China
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Study Endpoints
Primary Endpoints
Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity(AUC0-inf) for Part 1
Day1 and Day 3( or Day 5) of Cycle 1 for a 21-day cycle

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.

Duration of Severe Neutropenia in Cycle 1 (DSN)
At the end of Cycle 1 (each cycle is 21 days)

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.

Maximum Observed Plasma Concentration(Cmax) of Trilaciclib for Part 1
Day1 and Day 3( or Day 5) of Cycle 1 for a 21-day cycle

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.

Secondary Endpoints
Occurrence of Severe Neutropenia (SN)
From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months
Occurrence of Red Blood Cell Transfusion (on/After Week 5)
From week 5 to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months
Granulocyte Colony Stimulating Factor (G-CSF) Use Rate
From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I ( Safety run-in and PK Evaluation); Trilaciclib GroupACTIVE_COMPARATOR12 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 GroupACTIVE_COMPARATOR41 patients received trilaciclib(240mg/m\^2) plus chemotherapy
Part II ( Randomized Double-blind, Placebo-controlled ), Placebo GroupPLACEBO_COMPARATOR42 patients received placebo plus chemotherapy
Interventions
NameTypeDescription
Trilaciclib, carboplatin, etoposide,or TopotecanDRUGTrilaciclib plus carboplatin, etoposide for first line patients ;Trilaciclib plus Topotecan for second or third line patients
placebo, carboplatin, etoposide,or TopotecanDRUGplacebo plus carboplatin, etoposide for first line patients ;placebo plus Topotecan for second or third line patients
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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); ...

Countries:China
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