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NCT02499770 · OUTCOME

Best Overall Tumor Response Based on Blinded Independent Central Review (BICR) Assessments in Part 1

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) · Source last updated 2020-08-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline, end of every two 21-day cycles, up until disease progression to a maximum of the time at least 70% OS events observed (a maximum of 4 years)

What was measured

Tumor response was assessed by CT or MRI. Overall visit response by RECIST v1.1 was determined by BICR. Tumor response data were used to determine each participant's time point response \& BOR. CR was disappearance of all TLs, any pathological lymph nodes selected as TLs must have reduced in short axis to \<10 mm. PR was at least a 30% decrease from baseline in the sum of diameters of TLs, as long as criteria for PD were not met. PD was a ≥20% increase in the smallest sum of diameters of TLs since treatment started (including baseline) and an absolute increase of ≥5 mm. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Analysis population: Response evaluable analysis set included all participants in the safety analysis set who had at least 1 post-baseline tumor assessment, or clinical progression as noted by the investigator before their first post-baseline tumor scan, or who died due to disease progression before their first post-baseline tumor scan.

Groups in this outcome

Part 1: Cohort 1 Trilaciclib 200 mg/m^2

Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

Part 1: Cohort 2 Trilaciclib 240mg/m^2

Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: Cohort 1 Trilaciclib 200 mg/m^210
Part 1: Cohort 2 Trilaciclib 240mg/m^28

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^21Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^26Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^28Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^22Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^20Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^20Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
Unconfirmed CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^20Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
Unconfirmed PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^22Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    SD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    PD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Not evaluable
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Unconfirmed CR
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Unconfirmed PR
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Tumor response was assessed by CT or MRI. Overall visit response by RECIST v1.1 was determined by BICR. Tumor response data were used to determine each participant's time point response \& BOR. CR was disappearance of all TLs, any pathological lymph nodes selected as TLs must have reduced in short axis to \<10 mm. PR was at least a 30% decrease from baseline in the sum of diameters of TLs, as long as criteria for PD were not met. PD was a ≥20% increase in the smallest sum of diameters of TLs since treatment started (including baseline) and an absolute increase of ≥5 mm. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
groups
  1. description
    Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG000
    title
    Part 1: Cohort 1 Trilaciclib 200 mg/m^2
  2. description
    Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG001
    title
    Part 1: Cohort 2 Trilaciclib 240mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
Response evaluable analysis set included all participants in the safety analysis set who had at least 1 post-baseline tumor assessment, or clinical progression as noted by the investigator before their first post-baseline tumor scan, or who died due to disease progression before their first post-baseline tumor scan.
reporting Status
POSTED
time Frame
Baseline, end of every two 21-day cycles, up until disease progression to a maximum of the time at least 70% OS events observed (a maximum of 4 years)
title
Best Overall Tumor Response Based on Blinded Independent Central Review (BICR) Assessments in Part 1
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice