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NCT03041311 · OUTCOME

Best Overall Response

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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

For all patients, the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) tumor response data were used to determine each patient's visit response (TPR = time point response). Per RECIST v1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions, Stable Disease, neither sufficient shrinkage or increase to quality for PR or PD. Objective Response Rate (ORR) = CR + PR. The TPR at each visit was determined in 2 ways: (1) derived programmatically at the time of analysis using the information from target lesions, non-target lesions, and new lesions based on data collected through eCRF; and (2) judged by the investigator as collected in the eCRF. Results shown here are from the programmatically derived assessments.

Analysis population: Response Evaluable Analysis Set

Groups in this outcome

Trilaciclib+Etoposide/Carboplatin/Atezolizumab

Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 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/Atezolizumab50
Placebo+Etoposide/Carboplatin/Atezolizumab52

Reported measurements

Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab1Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab28Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab32Not reportedNot reportedNot reportedNot reported
Stable Disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab20Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab14Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab2Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab2Not reportedNot reportedNot reportedNot reported
Not Evaluable (NE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab2Not reportedNot reportedNot reportedNot reported
Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab1Not reportedNot reportedNot reportedNot reported
Objective response rate (CR+PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab28Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab33Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        32
    title
    Partial Response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        14
    title
    Stable Disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Progressive Disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Not Evaluable (NE)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Missing
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        33
    title
    Objective response rate (CR+PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      52
    units
    Participants
description
For all patients, the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) tumor response data were used to determine each patient's visit response (TPR = time point response). Per RECIST v1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions, Stable Disease, neither sufficient shrinkage or increase to quality for PR or PD. Objective Response Rate (ORR) = CR + PR. The TPR at each visit was determined in 2 ways: (1) derived programmatically at the time of analysis using the information from target lesions, non-target lesions, and new lesions based on data collected through eCRF; and (2) judged by the investigator as collected in the eCRF. Results shown here are from the programmatically derived assessments.
groups
  1. description
    Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 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
COUNT_OF_PARTICIPANTS
population Description
Response Evaluable Analysis Set
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
Best Overall Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice