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NCT03041311 · OUTCOME

Progression-Free Survival

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC · Source last updated 2025-09-25

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

Measure
NUMBER
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.

What was measured

Progression-free survival (PFS) was defined as the time (number of months) from date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever came first.

Analysis population: Intent-to-treat

Groups in this outcome

Trilaciclib+Etoposide/Carboplatin/Atezolizumab

Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.

Placebo+Etoposide/Carboplatin/Atezolizumab

Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.

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

Analysis denominator · Participants

GroupSource count
Trilaciclib+Etoposide/Carboplatin/Atezolizumab54
Placebo+Etoposide/Carboplatin/Atezolizumab53

Reported measurements

25%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab3.7Not reported2.74.2Not reported
Placebo+Etoposide/Carboplatin/Atezolizumab4.0Not reported3.14.3Not reported
Median
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab5.9Not reported4.27.1Not reported
Placebo+Etoposide/Carboplatin/Atezolizumab5.4Not reported4.35.7Not reported
75%
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab8.5Not reported7.110.4Not reported
Placebo+Etoposide/Carboplatin/Atezolizumab6.4Not reported5.78.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.7
        upper Limit
        4.2
        value
        3.7
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        4.3
        value
        4.0
    title
    25%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        7.1
        value
        5.9
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        5.7
        value
        5.4
    title
    Median
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.1
        upper Limit
        10.4
        value
        8.5
      2. group Id
        OG001
        lower Limit
        5.7
        upper Limit
        8.9
        value
        6.4
    title
    75%
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      53
    units
    Participants
description
Progression-free survival (PFS) was defined as the time (number of months) from date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever came first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
    id
    OG000
    title
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
  2. description
    Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
    id
    OG001
    title
    Placebo+Etoposide/Carboplatin/Atezolizumab
param Type
NUMBER
population Description
Intent-to-treat
reporting Status
POSTED
time Frame
From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
title
Progression-Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice