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NCT02499770 · OUTCOME

Best Overall Tumor Response Based on Assessments in Part 2

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 derived programmatically using data from TLs, NTLs, \& new lesions. 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 2: Placebo

Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

Part 2: Trilaciclib 240 mg/m^2

Participants received trilaciclib 240 mg/m\^2 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 2: Placebo37
Part 2: Trilaciclib 240 mg/m^236

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo1Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^20Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo19Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^224Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo12Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^29Not reportedNot reportedNot reportedNot reported
PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo4Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^21Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo1Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Unconfirmed CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo0Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^20Not reportedNot reportedNot reportedNot reported
Unconfirmed PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo6Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^24Not 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
        19
      2. group Id
        OG001
        value
        24
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        9
    title
    SD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    PD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      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
        6
      2. group Id
        OG001
        value
        4
    title
    Unconfirmed PR
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      36
    units
    Participants
description
Tumor response was assessed by CT or MRI. Overall visit response by RECIST v1.1 was derived programmatically using data from TLs, NTLs, \& new lesions. 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 placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG000
    title
    Part 2: Placebo
  2. description
    Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG001
    title
    Part 2: Trilaciclib 240 mg/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 Assessments in Part 2
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice