NCT03041311 · OUTCOME

Number of Cycles Completed (Induction Period and Maintenance Period)

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: MEAN
Unit: Cycles
Interval / dispersion: Standard Deviation
Time frame: From date of first dose, 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 49 cycles.

What was measured

Patients were considered to have started a cycle if they have received at least one dose of any study drug (carboplatin, etoposide, atezolizumab or trilaciclib).

Analysis population: Safety analysis

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

Group	Source count
Trilaciclib+Etoposide/Carboplatin/Atezolizumab	52
Placebo+Etoposide/Carboplatin/Atezolizumab	53

Reported measurements

Induction Period

Analysis denominator · Participants

Group	Source count
Trilaciclib+Etoposide/Carboplatin/Atezolizumab	52
Placebo+Etoposide/Carboplatin/Atezolizumab	53

Values in Cycles · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab	4	0.6	Not reported	Not reported	Not reported
Placebo+Etoposide/Carboplatin/Atezolizumab	4	0.8	Not reported	Not reported	Not reported

Maintenance Period

Analysis denominator · Participants

Group	Source count
Trilaciclib+Etoposide/Carboplatin/Atezolizumab	41
Placebo+Etoposide/Carboplatin/Atezolizumab	47

Values in Cycles · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab	10	11.9	Not reported	Not reported	Not reported
Placebo+Etoposide/Carboplatin/Atezolizumab	10	11.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.6
value
4
group Id
OG001
spread
0.8
value
4
denoms
counts
group Id
OG000
value
52
group Id
OG001
value
53
units
Participants
title
Induction Period
categories
measurements
group Id
OG000
spread
11.9
value
10
group Id
OG001
spread
11.3
value
10
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
47
units
Participants
title
Maintenance Period

denoms

counts
group Id
OG000
value
52
group Id
OG001
value
53
units
Participants

description

Patients were considered to have started a cycle if they have received at least one dose of any study drug (carboplatin, etoposide, atezolizumab or trilaciclib).

dispersion Type

Standard Deviation

groups

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
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

MEAN

population Description

Safety analysis

reporting Status

POSTED

time Frame

From date of first dose, 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 49 cycles.

title

Number of Cycles Completed (Induction Period and Maintenance Period)

type

SECONDARY

unit Of Measure

Cycles

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

Preserved source evidence · Not medical advice