Carboplatin, Etoposide, and Atezolizumab With or Without... | NCT03041311

ID	Type	Description	Link
2017-000358-20	EudraCT Number

Name	Class
Roche-Genentech	INDUSTRY

Label	Type	Description	Intervention Names
trilaciclib+etoposide/carboplatin/atezolizumab	Experimental	Induction: Patients received trilaciclib 240 mg/m² administered intravenously (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 area under the concentration-time curve (AUC) = 5 milligrams per milliliter per minute (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.	Drug: Trilaciclib Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab
placebo+etoposide/carboplatin/atezolizumab	Experimental	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 be 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.	Drug: Placebo Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab

Name	Type	Description	Arm Group Labels	Other Names
Trilaciclib	Drug	Trilaciclib IV	trilaciclib+etoposide/carboplatin/atezolizumab

Measure	Description	Time Frame
Duration of Severe (Grade 4) Neutropenia in Cycle 1	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.	Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).
Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia	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.	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.

Measure	Description	Time Frame
All-Cause Dose Reductions	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.

Name	Affiliation	Role
Clinical Contact	G1 Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Beverly Hills Cancer Center		Beverly Hills	California	90211	United States
St. Jude Heritage Healthcare

PubMed Identifier	Type	Citation	Retractions
33348420	Background	Daniel D, Kuchava V, Bondarenko I, Ivashchuk O, Reddy S, Jaal J, Kudaba I, Hart L, Matitashvili A, Pritchett Y, Morris SR, Sorrentino JA, Antal JM, Goldschmidt J. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2021 May 15;148(10):2557-2570. doi: 10.1002/ijc.33453. Epub 2021 Jan 12.
33895103

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 14, 2018	Oct 26, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Duration of Severe (Grade 4) Neutropenia in Cycle 1

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.

Posted

Mean

Standard Deviation

days

Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00054 OG00153

Title

Denominators

Categories

Title	Measurements
	OG0000± 1.0 OG0014± 4.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.	non-parametric ANCOVA	Hochberg-based gatekeeping procedure	<0.0001	A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.					1-Sided	95

Primary

Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia

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.

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	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

Secondary

All-Cause Dose Reductions

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.

Posted

Number

Events/Cycle

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.

ID	Title	Description
OG000	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

Secondary

Number of Participants With at Least 1 Occurrence of RBC Transfusion on/After Week 5 (Proportion of Patients)

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.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

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

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.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Overall Survival (OS)

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)

Posted

Number

95% Confidence Interval

Months

From date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.

ID	Title	Description
OG000	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.
OG001	Placebo+Etoposide/Carboplatin/Atezolizumab

Secondary

Major Adverse Hematologic Events (MAHE) (Composite Endpoint)

The composite endpoint "major adverse hematologic events" (MAHE) included the following aspects of myelosuppression:

All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event.

All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event.

Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event.

Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis.

Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period 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.

Posted

Number

event rate per week

ID	Title	Description
OG000	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.

Secondary

Best Overall Response

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.

Response Evaluable Analysis Set

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	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.

Secondary

Duration of Objective Response (Complete Response or Partial Response)

Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.

Response Evaluable Analysis Set

Posted

Number

95% Confidence Interval

months

ID	Title	Description
OG000	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.
OG001

Secondary

Progression-Free Survival

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.

Intent-to-treat

Posted

Number

95% Confidence Interval

months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With at Least 1 Occurrence of Febrile Neutropenia

The criterion for identifying febrile neutropenia was if the preferred term for an adverse event was "FEBRILE NEUTROPENIA." Any occurrence of a febrile neutropenia event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. Each febrile neutropenia event with a unique start date during the induction treatment period was defined as a separate event.

Intent-to-treat (ITT Analysis Set)

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With at Least 1 Occurrence of Grade 3 or 4 Hematologic Laboratory Abnormalities

The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a patient had at least 1 cycle with at least 1 Grade 3 or 4 hematologic toxicities during the Induction Period, the patient was assigned as "Yes" to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was "No". If a patient did not have an event, the value of 0 was assigned to that patient.

Intent-to-treat

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With at Least 1 Occurrence of Erythropoiesis Stimulating Agent (ESA) Administration

Any ESA administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with ESA administration during an induction cycle or the Induction Period was considered to have occurrence of ESA administration. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (ie TEXT4 for CODE4) takes the value "OTHER ANTIANEMIC PREPARATIONS," the medication was classified as ESAs.

Intent-to-treat

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With at Least 1 Occurrence of Platelet Transfusion

Any occurrence of a platelet transfusion during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each platelet transfusion event with a unique start date during the induction treatment period was defined as a separate event.

Intent-to-treat

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With at Least 1 Occurrence of Infection Serious Adverse Events (SAEs)

Any occurrence of an infection SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. The criterion for identifying the proper infection SAE records was as follows: if the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1 takes value "INFECTIONS AND INFESTATIONS," and the AE was a serious event.

Intent-to-treat

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With at Least 1 Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)

Any occurrence of a pulmonary SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each pulmonary infection SAE with a unique start date during the induction treatment period was defined as separate event. The criterion for identifying the proper pulmonary infection SAE records was as follows:

The SOC from MedDRA Version 20.1 took the value "INFECTIONS AND INFESTATIONS," the adverse event was a serious event, and the PT took values from the following list of PTs under the category of pulmonary infection adverse events: bronchiolitis, bronchitis, infectious pleural effusion, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.

Intent-to-treat

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With at Least 1 Occurrence of IV Antibiotic Uses

Occurrence of an IV antibiotics administration during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of IV antibiotics administration ≥ 1 is observed, No for other scenarios. Each IV antibiotic with a unique start date during the induction treatment period will be defined as a separate event. The criteria for identifying an IV antibiotic administration event was (1) if the therapeutic subgroup from WHO-DD Version September 2017 (ie, TEXT2 for CODE2) takes the value "ANTIBACTERIALS FOR SYSTEMIC USE," and (2) the route of medication was "intravenous" or the route was "other" with the detailed specification as "IVPB."

Intent-to-treat

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Duration of Study Drug Exposure (Induction Period and Maintenance Period)

Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.

Safety analysis

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Mean

Standard Deviation

Days

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 1162 days.

ID	Title	Description
OG000	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.
OG001	Placebo+Etoposide/Carboplatin/Atezolizumab

Secondary

Number of Cycles Completed (Induction Period and Maintenance Period)

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).

Safety analysis

Posted

Mean

Standard Deviation

Cycles

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Relative Dose Intensity of Trilaciclib/Placebo, Carboplatin, Etoposide, Atezolizumab (Induction Period) and Atezolizumab (Maintenance Period)

Relative dose intensity is defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity is defined as the cumulative planned dose through the study divided by (number of cycles * 3 weeks)

Safety Analysis

Posted

Mean

Standard Deviation

percentage of dose

ID	Title	Description
OG000	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.
OG001	Placebo+Etoposide/Carboplatin/Atezolizumab

Secondary

Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Induction Period)

After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A "Cycle Day Status" page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers "Yes"), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.

Safety analysis

Posted

Count of Participants

Participants

Induction Period. From date of first dose, 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.

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Maintenance Period)

Safety analysis

Posted

Count of Participants

Participants

Maintenance Period. From date of first maintenance dose, 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1160 days.

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Any Missed Doses [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)

Missed doses are identified on the dosing page of each study drug based on the question "Was the dose given?". The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question "Was the dose given?" is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.

Safety analysis

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Any Missed Doses of Atezolizumab (Overall Treatment Period)

Safety analysis

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Any Dose Interruptions [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)

Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.

Safety analysis

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Any Interrupted Doses of Atezolizumab (Overall Treatment Period)

Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.

Safety analysis

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)

No dose reductions were allowed for trilaciclib or atezolizumab during the study.

Safety analysis

Posted

Count of Participants

Participants

ID	Title	Description
OG000	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.
OG001	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.

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0005 events3 affected52 at risk EG0018 events8 affected53 at risk
Sepsis	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events2 affected53 at risk
Urinary Tract Infection	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0011 events1 affected53 at risk
Bronchiolitis	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Bronchitis	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Cellulitis	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Empyema	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events1 affected53 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events1 affected53 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events2 affected52 at risk EG0012 events2 affected53 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0012 events2 affected53 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0011 events1 affected53 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0014 events4 affected53 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0013 events3 affected53 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events1 affected52 at risk EG0011 events1 affected53 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0011 events1 affected53 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0011 events1 affected53 at risk
Balance disorder	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Cognitive disorder	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Ischaemic stroke	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Paraneoplastic neurological syndrome	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Non-cardiac chest pain	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0011 events1 affected53 at risk
Asthenia	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events1 affected53 at risk
Oedema peripheral	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Pyrexia	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0012 events2 affected53 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0005 events1 affected52 at risk EG0012 events2 affected53 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Thrombosis	Vascular disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk
Platelet count decreased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Confusional state	Psychiatric disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected53 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected53 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG00060 events19 affected52 at risk EG001122 events32 affected53 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG00035 events19 affected52 at risk EG00185 events28 affected53 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG00014 events7 affected52 at risk EG00144 events21 affected53 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version 23.1.	Systematic Assessment	EG0005 events4 affected52 at risk EG00138 events14 affected53 at risk
Fatigue	General disorders	MedDRA version 23.1.	Systematic Assessment	EG00024 events16 affected52 at risk EG00132 events20 affected53 at risk
Asthenia	General disorders	MedDRA version 23.1.	Systematic Assessment	EG00017 events8 affected52 at risk EG00121 events9 affected53 at risk
Non-cardiac chest pain	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0005 events5 affected52 at risk EG0017 events7 affected53 at risk
Pyrexia	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0008 events8 affected52 at risk EG0015 events4 affected53 at risk
Oedema peripheral	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0004 events4 affected52 at risk EG0014 events4 affected53 at risk
Chills	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events2 affected52 at risk EG0015 events4 affected53 at risk
Gait disturbance	General disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0013 events3 affected53 at risk
Nausea	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG00036 events20 affected52 at risk EG00130 events18 affected53 at risk
Constipation	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0006 events5 affected52 at risk EG00115 events12 affected53 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG00013 events9 affected52 at risk EG00110 events6 affected53 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG00010 events6 affected52 at risk EG0016 events5 affected53 at risk
Stomatitis	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0003 events3 affected52 at risk EG0015 events3 affected53 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0015 events4 affected53 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0004 events4 affected52 at risk EG0010 events0 affected53 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0008 events7 affected52 at risk EG00121 events18 affected53 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0009 events8 affected52 at risk EG0013 events3 affected53 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG00010 events5 affected52 at risk EG0015 events4 affected53 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG00111 events3 affected53 at risk
Platelet count decreased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG00010 events5 affected52 at risk EG00163 events13 affected53 at risk
Neutrophil count decreased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG00011 events3 affected52 at risk EG00150 events11 affected53 at risk
White blood cell count decreased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG00020 events7 affected52 at risk EG00125 events6 affected53 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG00011 events6 affected52 at risk EG0014 events2 affected53 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG00010 events5 affected52 at risk EG0014 events2 affected53 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0005 events4 affected52 at risk EG0016 events3 affected53 at risk
Blood creatinine increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0004 events3 affected52 at risk EG0015 events4 affected53 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0005 events3 affected52 at risk EG0018 events4 affected53 at risk
Weight decreased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0005 events4 affected52 at risk EG0013 events3 affected53 at risk
Lipase increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0002 events1 affected52 at risk EG00110 events5 affected53 at risk
Weight increased	Investigations	MedDRA version 23.1.	Systematic Assessment	EG0003 events3 affected52 at risk EG0010 events0 affected53 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG00013 events8 affected52 at risk EG00120 events13 affected53 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0008 events8 affected52 at risk EG00112 events8 affected53 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0003 events3 affected52 at risk EG0017 events5 affected53 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events2 affected52 at risk EG0014 events3 affected53 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0014 events4 affected53 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0003 events3 affected52 at risk EG0012 events2 affected53 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0013 events3 affected53 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0013 events3 affected53 at risk
Urinary tract infection	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0007 events5 affected52 at risk EG0014 events3 affected53 at risk
Pneumonia	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0004 events4 affected52 at risk EG0014 events3 affected53 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0004 events3 affected52 at risk EG0015 events3 affected53 at risk
Bronchitis	Infections and infestations	MedDRA version 23.1.	Systematic Assessment	EG0004 events3 affected52 at risk EG0012 events2 affected53 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG0006 events5 affected52 at risk EG00111 events9 affected53 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG0005 events4 affected52 at risk EG00110 events9 affected53 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG00011 events5 affected52 at risk EG0013 events3 affected53 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG00013 events4 affected52 at risk EG0014 events4 affected53 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG0006 events4 affected52 at risk EG0012 events2 affected53 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 23.1.	Systematic Assessment	EG0007 events3 affected52 at risk EG0011 events1 affected53 at risk
Dizziness	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG00011 events9 affected52 at risk EG00113 events9 affected53 at risk
Headache	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG00013 events9 affected52 at risk EG0019 events6 affected53 at risk
Tremor	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0013 events3 affected53 at risk
Dysgeusia	Nervous system disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0013 events3 affected53 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG00010 events5 affected52 at risk EG0013 events3 affected53 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0005 events5 affected52 at risk EG0012 events2 affected53 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0003 events3 affected52 at risk EG0013 events3 affected53 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events2 affected52 at risk EG0014 events3 affected53 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events2 affected52 at risk EG0013 events3 affected53 at risk
Hypertension	Vascular disorders	MedDRA version 23.1.	Systematic Assessment	EG0006 events3 affected52 at risk EG0014 events3 affected53 at risk
Flushing	Vascular disorders	MedDRA version 23.1.	Systematic Assessment	EG0004 events3 affected52 at risk EG0012 events2 affected53 at risk
Hypotension	Vascular disorders	MedDRA version 23.1.	Systematic Assessment	EG0001 events1 affected52 at risk EG0014 events3 affected53 at risk
Phlebitis	Vascular disorders	MedDRA version 23.1.	Systematic Assessment	EG0004 events3 affected52 at risk EG0010 events0 affected53 at risk
Hypothyroidism	Endocrine disorders	MedDRA version 23.1.	Systematic Assessment	EG0003 events3 affected52 at risk EG0017 events7 affected53 at risk
Hyperthyroidism	Endocrine disorders	MedDRA version 23.1.	Systematic Assessment	EG0003 events2 affected52 at risk EG0016 events6 affected53 at risk
Anxiety	Psychiatric disorders	MedDRA version 23.1.	Systematic Assessment	EG0008 events3 affected52 at risk EG0015 events5 affected53 at risk
Confusional state	Psychiatric disorders	MedDRA version 23.1.	Systematic Assessment	EG0002 events2 affected52 at risk EG0015 events4 affected53 at risk
Insomnia	Psychiatric disorders	MedDRA version 23.1.	Systematic Assessment	EG0000 events0 affected52 at risk EG0014 events4 affected53 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA version 23.1.	Systematic Assessment	EG0004 events1 affected52 at risk EG0015 events3 affected53 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 23.1.	Systematic Assessment	EG00011 events5 affected52 at risk EG0012 events2 affected53 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 23.1.	Systematic Assessment	EG0003 events2 affected52 at risk EG0016 events4 affected53 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	42	54	17	52	49	52
EG001	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.	44	53	25	53	52	53

ID	Term
C000708352	trilaciclib
D016190	Carboplatin
D005047	Etoposide
C000594389	atezolizumab