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← Small Cell Lung Cancer

NCT03041311 · STUDY IN CONTEXT

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of \<0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10⁹/L and (2) no other ANC values \<0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.

Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.

→

primary · POSTED

The occurrence of severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value \<0.5 × 10\^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.

Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.

→

secondary · POSTED

Dose reductions are not permitted for trilaciclib or atezolizumab. Dose reductions for E/P are derived from changes in the protocol-specified dose on the dosing page and correspond to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any patient. Simultaneous reduction in the doses of etoposide and carboplatin were counted as 1 dose reduction.

Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.

→

secondary · POSTED

For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Each red blood cell transfusion with a unique start date on/after Week 5 on study during the Induction was defined as a separate event.

Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.

→

secondary · POSTED

For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.

Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.

→

secondary · POSTED

Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.

Intent-to-treat (ITT Analysis Set)

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03041311
qol key
qol-0004
source section id
NCT03041311-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)
measure definition
For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.
time frame
Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03041311
trial label
Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0000
    source section id
    NCT03041311-om-0000
    source outcome index
    0
    endpoint
    Duration of Severe (Grade 4) Neutropenia in Cycle 1
    endpoint definition
    Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of \<0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10⁹/L and (2) no other ANC values \<0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.
    time origin
    Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0001
    source section id
    NCT03041311-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia
    endpoint definition
    The occurrence of severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value \<0.5 × 10\^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.
    time origin
    Induction Period. From date of randomization, 21 day treatment cycles up to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0002
    source section id
    NCT03041311-om-0002
    source outcome index
    2
    endpoint
    All-Cause Dose Reductions
    endpoint definition
    Dose reductions are not permitted for trilaciclib or atezolizumab. Dose reductions for E/P are derived from changes in the protocol-specified dose on the dosing page and correspond to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any patient. Simultaneous reduction in the doses of etoposide and carboplatin were counted as 1 dose reduction.
    time origin
    Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0003
    source section id
    NCT03041311-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With at Least 1 Occurrence of RBC Transfusion on/After Week 5 (Proportion of Patients)
    endpoint definition
    For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Each red blood cell transfusion with a unique start date on/after Week 5 on study during the Induction was defined as a separate event.
    time origin
    Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 374 days.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0004
    source section id
    NCT03041311-om-0004
    source outcome index
    4
    endpoint
    Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)
    endpoint definition
    For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.
    time origin
    Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0005
    source section id
    NCT03041311-om-0005
    source outcome index
    5
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.
    time origin
    From date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT Analysis Set)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    regimen
    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
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    regimen
    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 be 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.
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    regimen
    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
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    regimen
    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 be 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.
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    regimen
    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.
    analyzed count
    53
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03041311-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    harm key
    EG000
    source section id
    NCT03041311-ae
    event group key
    EG000
    event group label
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
    serious affected
    17
    serious at risk
    52
    other affected
    49
    other at risk
    52
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events collected beginning with informed consent through 30 days after last dose of study drug. Treatment emergent serious adverse events collected through 90 days after last dose of study drug, assessed up to a maximum of 1192 days (maximum duration of exposure plus 30 days).
    event definition
    Adverse events were assessed using the safety analysis set, which included all randomized patients who received at least 1 dose of any study drug (etoposide, carboplatin, atezolizumab, or trilaciclib). Analyses using the safety analysis set were conducted based on the actual treatment received.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    harm key
    EG001
    source section id
    NCT03041311-ae
    event group key
    EG001
    event group label
    Placebo+Etoposide/Carboplatin/Atezolizumab
    serious affected
    25
    serious at risk
    53
    other affected
    52
    other at risk
    53
    frequency threshold
    5
    collection period
    Treatment-emergent adverse events collected beginning with informed consent through 30 days after last dose of study drug. Treatment emergent serious adverse events collected through 90 days after last dose of study drug, assessed up to a maximum of 1192 days (maximum duration of exposure plus 30 days).
    event definition
    Adverse events were assessed using the safety analysis set, which included all randomized patients who received at least 1 dose of any study drug (etoposide, carboplatin, atezolizumab, or trilaciclib). Analyses using the safety analysis set were conducted based on the actual treatment received.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03041311
    qol key
    qol-0004
    source section id
    NCT03041311-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)
    measure definition
    For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.
    time frame
    Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice