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← Small Cell Lung Cancer

NCT02514447 · STUDY IN CONTEXT

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

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 ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10\^9/L and (2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were randomized but never treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.

The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.

→

primary · POSTED

Number of Participants with 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 Treatment Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.

The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.

→

primary · POSTED

The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding * Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT * ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours)

The safety analysis set: All enrolled patients who received at least 1 dose of study drug.

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secondary · POSTED

Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan

All patients who had evaluable PK profiles for both treatments and analytes.

→

secondary · POSTED

Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause. Investigators followed the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.

→

secondary · POSTED

Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.

The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.

→

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 · Need for Treatment With Hematopoietic Growth Factors

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
NCT02514447
qol key
qol-0009
source section id
NCT02514447-om-0009
source outcome index
9
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Need for Treatment With Hematopoietic Growth Factors
measure definition
Percentage of patients requiring G-CSF administration.
time frame
During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the 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
NCT02514447
trial label
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
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
9
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    source section id
    NCT02514447-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 ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10\^9/L and (2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were randomized but never 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 (i.e., from date of first dose of study drug (Part 1)/randomization (Part 2) to the end of Cycle 1, each cycle = 21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the 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
    NCT02514447
    outcome key
    om-0001
    source section id
    NCT02514447-om-0001
    source outcome index
    1
    endpoint
    Occurrence of Severe (Grade 4) Neutropenia
    endpoint definition
    Number of Participants with 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 Treatment Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.
    time origin
    During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the 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
    NCT02514447
    outcome key
    om-0002
    source section id
    NCT02514447-om-0002
    source outcome index
    2
    endpoint
    Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1
    endpoint definition
    The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding * Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT * ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours)
    time origin
    Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1) to the end of Cycle 1, each cycle = 21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The safety analysis set: All enrolled patients who received at least 1 dose of study drug.
    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
    NCT02514447
    outcome key
    om-0003
    source section id
    NCT02514447-om-0003
    source outcome index
    3
    endpoint
    Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan
    endpoint definition
    Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan
    time origin
    Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients who had evaluable PK profiles for both treatments and analytes.
    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
    NCT02514447
    outcome key
    om-0004
    source section id
    NCT02514447-om-0004
    source outcome index
    4
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause. Investigators followed the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
    time origin
    From date of first dose of study drug (Part 1)/randomization (Part 2), until date of documented disease progression or death due to any cause (evaluated up to a maximum of 1335 days).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the 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
    NCT02514447
    outcome key
    om-0005
    source section id
    NCT02514447-om-0005
    source outcome index
    5
    endpoint
    Overall Survival (OS)
    endpoint definition
    Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.
    time origin
    From date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2220 days).
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    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
    NCT02514447
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
    regimen
    Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebo Topotecan
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
    regimen
    Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
    regimen
    Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
    regimen
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG004
    arm label
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
    regimen
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG005
    arm label
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
    regimen
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG006
    arm label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
    regimen
    Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG007
    arm label
    Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
    regimen
    Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG007
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0000
    arm key
    OG008
    arm label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
    regimen
    Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0000#groups/OG008
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
    regimen
    Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0001#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
    regimen
    Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0001#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
    regimen
    Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
    analyzed count
    32
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02514447-om-0001#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    harm key
    EG000
    source section id
    NCT02514447-ae
    event group key
    EG000
    event group label
    Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
    serious affected
    7
    serious at risk
    28
    other affected
    27
    other at risk
    28
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    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
    NCT02514447
    harm key
    EG001
    source section id
    NCT02514447-ae
    event group key
    EG001
    event group label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
    serious affected
    15
    serious at risk
    30
    other affected
    29
    other at risk
    30
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    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
    NCT02514447
    harm key
    EG002
    source section id
    NCT02514447-ae
    event group key
    EG002
    event group label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
    serious affected
    12
    serious at risk
    32
    other affected
    32
    other at risk
    32
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    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
    NCT02514447
    harm key
    EG003
    source section id
    NCT02514447-ae
    event group key
    EG003
    event group label
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
    serious affected
    2
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    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
    NCT02514447
    harm key
    EG004
    source section id
    NCT02514447-ae
    event group key
    EG004
    event group label
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    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
    NCT02514447
    harm key
    EG005
    source section id
    NCT02514447-ae
    event group key
    EG005
    event group label
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    harm key
    EG006
    source section id
    NCT02514447-ae
    event group key
    EG006
    event group label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
    serious affected
    0
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    harm key
    EG007
    source section id
    NCT02514447-ae
    event group key
    EG007
    event group label
    Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
    serious affected
    1
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT02514447
    harm key
    EG008
    source section id
    NCT02514447-ae
    event group key
    EG008
    event group label
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
    serious affected
    1
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    The SAE reporting period started at the time of informed consent and the AE reporting period started from the time of first dose of study drug; both were assessed through 30 calendar days after the last administration of trilaciclib (G1T28) + topotecan (assessed up to a maximum of 1689 days). All-Cause Mortality was assessed from the date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2196 days).
    event definition
    The safety analysis set (AEs and SAEs) includes all enrolled patients who received at least 1 dose of study drug (topotecan or trilaciclib/placebo). Analyses using the safety analysis set will be conducted on the basis of the actual treatment received. The intent-to-treat (ITT) analysis set (All-Cause Mortality) includes all enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
    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
    NCT02514447
    qol key
    qol-0009
    source section id
    NCT02514447-om-0009
    source outcome index
    9
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Need for Treatment With Hematopoietic Growth Factors
    measure definition
    Percentage of patients requiring G-CSF administration.
    time frame
    During the treatment period. From date of first dose (Part 1)/randomization (Part 2), 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to 1090 days).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the 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