Trial Outcomes & Findings for Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC) (NCT NCT02978716)

Last Updated: 2022-03-23

Results Overview

DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (\<) 0.5 × 10\^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (\>=) 0.5 × 10\^9/L that met the following: (1) occurred after the ANC value of \< 0.5 × 10\^9 cells/L and (2) no other ANC values \< 0.5 × 10\^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

From randomization to the end of Cycle 1 (Each cycle= 21 days)

Results posted on

2022-03-23

Participant Flow

This study was conducted at 34 sites in the United States (US), Belgium, Bulgaria, Croatia, Republic of Macedonia, and Serbia from 02 February 2017 (first participant enrolled) to 28 February 2020 (last participant last visit).

Participants were screened within 28 days before the first dose of the treatment. Informed consent was obtained up to 28 days prior to first study drug administration. For tumor assessment, all sites of disease were assessed radiologically at screening. A total of 102 participants were randomized in this study.

Participant milestones

Participant milestones
Measure	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square \[mg/m\^2\] and carboplatin area under the curve \[AUC\] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Overall Study STARTED	34	33	35
Overall Study ITT Population	34	33	35
Overall Study Safety Analysis Set	30	33	35
Overall Study Treated	30	33	35
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	34	33	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square \[mg/m\^2\] and carboplatin area under the curve \[AUC\] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Overall Study Death	25	13	20
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	6	4	5
Overall Study Sponsor terminated	2	13	9
Overall Study Other	1	3	0

Baseline Characteristics

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Total n=102 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 13.6 • n=5 Participants	56 years STANDARD_DEVIATION 12.1 • n=7 Participants	58 years STANDARD_DEVIATION 9.5 • n=5 Participants	56 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	32 Participants n=7 Participants	35 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	28 Participants n=7 Participants	33 Participants n=5 Participants	93 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	78 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization to the end of Cycle 1 (Each cycle= 21 days)

Population: The ITT analysis set included all randomized participants.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1	1 days Standard Deviation 2.6	1 days Standard Deviation 2.2	2 days Standard Deviation 3.5

PRIMARY outcome

Timeframe: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days

Population: The ITT analysis set included all randomized participants.

Number of participants with Grade 4 SN was a binary variable. If a participants had at least 1 ANC value \< 0.5 ×10\^9/L during the treatment period, the participants was assigned as "yes" to the occurrence of SN. Otherwise, it was "no".

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Severe (Grade 4) Neutropenia (SN) Grade 4 neutropenia: No	27 Participants	25 Participants	21 Participants
Number of Participants With Severe (Grade 4) Neutropenia (SN) Grade 4 neutropenia: Yes	8 Participants	9 Participants	12 Participants

SECONDARY outcome

Timeframe: From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days

Population: The response-evaluable (RE) analysis set included all participants who were in the modified intent-to-treat (mITT) analysis set, had measurable disease (target lesions \[TLs\]) at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan.

BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): \>= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=31 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=24 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Complete response (CR)	0 Participants	0 Participants	0 Participants
Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Not evaluable (NE)	1 Participants	0 Participants	0 Participants
Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Missing	1 Participants	0 Participants	1 Participants
Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Stable disease (SD)	15 Participants	11 Participants	9 Participants
Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Progressive disease (PD)	3 Participants	6 Participants	5 Participants
Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Partial response (PR)	11 Participants	7 Participants	15 Participants

SECONDARY outcome

Timeframe: From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days

Population: The RE analysis set included all participants who were in the mITT analysis set, had measurable disease TLs at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

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. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=11 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=7 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=15 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator	9.6 months Interval 3.1 to 12.6	7.8 months Interval 7.5 to Due to small number of events, estimates (upper limit of 95% Confidence interval) from Kaplan-Meier survival curves could not be derived.	11.5 months Interval 4.8 to 17.8

SECONDARY outcome

Timeframe: From date of randomization to date of death due to any cause, assessed up to a maximum of 1120 days

Population: The ITT analysis set included all randomized participants.

Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Overall Survival (OS)	17.8 months Interval 12.9 to 32.7	12.6 months Interval 6.3 to 15.6	NA months Interval 10.2 to Data could not be estimated due to higher number (\>50%) of censored participants.

SECONDARY outcome

Timeframe: From date of randomization until the occurrence of disease progression, death due to any cause or a censoring event, assessed up to a maximum of 875 days

Population: The ITT analysis set included all randomized participants.

PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: \>= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator	7.3 months Interval 6.2 to 13.9	5.7 months Interval 3.3 to 9.2	9.4 months Interval 6.1 to 11.9

SECONDARY outcome

Timeframe: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 \* \[Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)\]); for carboplatin (100 \* \[Dose intensity (AUC/week)/ (4/3) (AUC/week)\]) and for trilaciclib (100 \* \[Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)\] for Group 2 and 100 \* \[Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)\] for Group 3).

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Relative Dose Intensity of Gemcitabine and Carboplatin Carboplatin	81.7 percentage of dose Standard Deviation 16.09	77.5 percentage of dose Standard Deviation 19.20	79.1 percentage of dose Standard Deviation 15.88
Relative Dose Intensity of Gemcitabine and Carboplatin Gemcitabine	81.0 percentage of dose Standard Deviation 14.49	79.1 percentage of dose Standard Deviation 18.29	80.8 percentage of dose Standard Deviation 12.51

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Duration of Exposure	168 days Interval 21.0 to 436.0	101 days Interval 21.0 to 469.0	161 days Interval 42.0 to 637.0

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Participants were considered to have started a cycle if they have received at least 1 dose of any study drug.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Cycles Participants Received Treatment in Each Treatment Arm	8 number of cycles Standard Deviation 4.8	6 number of cycles Standard Deviation 5.0	9 number of cycles Standard Deviation 6.6

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square \[mg/m\^2\]).

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Cumulative Dose of Gemcitabine	13277.2 mg/m^2 Standard Deviation 8722.51	10694.3 mg/m^2 Standard Deviation 9029.11	14680.9 mg/m^2 Standard Deviation 11557.90

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC).

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Cumulative Dose of Carboplatin	26.0 AUC (mg/mL/min) Standard Deviation 16.33	20.3 AUC (mg/mL/min) Standard Deviation 16.47	27.8 AUC (mg/mL/min) Standard Deviation 21.21

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)

Population: The pharmacokinetic (PK) analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.

The observed peak plasma concentration was determined from the plasma concentration-versus time data.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=7 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=6 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Maximum Observed Plasma Concentration (Cmax) of Trilaciclib	1630 ng/mL Standard Deviation 423	—	2280 ng/mL Standard Deviation 1790

SECONDARY outcome

Population: The PK analysis set included all dosed participants with evaluable PK data. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.

AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=7 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=6 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib	3800 hour* nanogram per milliliter (h*ng/mL) Standard Deviation 910	—	3610 hour* nanogram per milliliter (h*ng/mL) Standard Deviation 1870

SECONDARY outcome

t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg\*h/L).

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=6 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Terminal Elimination Half-Life (t1/2) of Trilaciclib	5.31 hours Interval 4.36 to 6.29	—	5.27 hours Interval 3.98 to 6.64

SECONDARY outcome

The observed peak plasma concentration was determined from the plasma concentration-versus time data.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=1 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Maximum Observed Plasma Concentration (Cmax) of Gemcitabine	23.8 microgram per milliliter (mcg/mL) Standard Deviation 25.9	NA microgram per milliliter (mcg/mL) Standard Deviation NA Data was not available since only one participant had sample in Group 1 and it was sufficient only for assessment of carboplatin.	18.0 microgram per milliliter (mcg/mL) Standard Deviation 4.04

SECONDARY outcome

AUC0-t was calculated with the linear/log-trapezoidal method.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=1 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine	15.4 hourmicrogram per milliliter (hmcg/mL) Standard Deviation 7.11	NA hourmicrogram per milliliter (hmcg/mL) Data was not available since only one participant had sample in Group 1 and it was sufficient only for assessment of carboplatin.	20.4 hourmicrogram per milliliter (hmcg/mL) Standard Deviation 11.6

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=1 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Terminal Elimination Half-Life (t1/2) of Free Carboplatin	1.79 hours Interval 1.35 to 4.86	5.23 hours	2.49 hours Interval 1.32 to 2.93

SECONDARY outcome

Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=1 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=3 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Clearance (CL) of of Free Carboplatin	13.7 Liter/hour (L/h) Standard Deviation 4.48	6.65 Liter/hour (L/h)	14.0 Liter/hour (L/h) Standard Deviation 2.80

SECONDARY outcome

Vss was the volume of distribution at steady state of free carboplatin was reported.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=1 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=5 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Volume of Distribution at Steady State (Vss) of Free Carboplatin	34.0 Liter Standard Deviation 8.99	44.4 Liter	35.0 Liter Standard Deviation 12.0

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for \>= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Grade 3 and 4 Hematologic Toxicities Participants with Grade 3 and 4 hematologic toxicities: Yes	27 Participants	25 Participants	30 Participants
Number of Participants With Grade 3 and 4 Hematologic Toxicities Participants with Grade 3 and 4 hematologic toxicities: No	8 Participants	9 Participants	3 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for \>= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as "Yes" to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was "No". If a participant did not have an event, the value of 0 was assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Grade 3 or 4 Thrombocytopenia	19 Participants	21 Participants	12 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration \> 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Major Adverse Hematologic Event (MAHE) Rate	0.080 event rate per week	0.153 event rate per week	0.108 event rate per week

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

The criterion for identifying FN was if the PT was "FEBRILE NEUTROPENIA" the occurrence during the treatment 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 participant did not have an event, the value of 0 was assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Febrile Neutropenia (FN)	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

Number of participants with infection SAEs during the treatment 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 participant did not have an event, the value of 0 was assigned to that participant. 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) takes value "INFECTIONS AND INFESTATIONS," and the AE was a serious event.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Infection SAEs Participants with Infection SAEs: Yes	0 Participants	2 Participants	0 Participants
Number of Participants With Infection SAEs Participants with Infection SAEs: No	35 Participants	32 Participants	33 Participants

SECONDARY outcome

Timeframe: From Day 35 through the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 508 days

Population: The ITT analysis set included all randomized participants.

Each RBC transfusion with a unique start date on/after 5 weeks on study during the treatment period was defined as a separate event. Occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if the total number of events \>=1 was observed and "No" for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35) Participants with RBC transfusions on/after Week 5: Yes	8 Participants	12 Participants	11 Participants
Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35) Participants with RBC transfusions on/after Week 5: No	27 Participants	22 Participants	22 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

Each platelet transfusion with a unique start date during the treatment period was defined as a separate event. The occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if the total number of events \>=1 was observed and No for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Platelet Transfusions Participants with platelet transfusion: Yes	6 Participants	4 Participants	3 Participants
Number of Participants With Platelet Transfusions Participants with platelet transfusion: No	29 Participants	30 Participants	30 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

The criterion for selecting proper records is as follows: If the chemical subgroup from the World Health Organization-Drug Dictionary (WHO-DD) takes value "COLONY STIMULATING FACTOR," the medication was classified as G-CSF. The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if the total number of events \>=1 was observed and "No" for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration Participants with G-CSF Administration: Yes	14 Participants	16 Participants	21 Participants
Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration Participants with G-CSF Administration: No	21 Participants	18 Participants	12 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

The occurrence during the treatment 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 participant did not have an event, the value of 0 was assigned to that participant. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (i.e., TEXT4 for CODE4) takes value "OTHER ANTIANEMIC PREPARATIONS", the medication was classified as ESAs.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration Participants with ESA Administration: Yes	3 Participants	4 Participants	2 Participants
Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration Participants with ESA Administration: No	32 Participants	30 Participants	31 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

The criteria for identifying an IV antibiotic administration event was (1) if the Therapeutic subgroup from WHO-DD version takes value "ANTIBACTERIALS FOR SYSTEMIC USE", and (2) the route of medication was "intravenous" or the route was "other" with the detailed specification as "IVPB". The occurrence during the treatment 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 participant did not have an event, the value of 0 was assigned to that participant.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Intravenous Antibiotics Use Participants with Intravenous Antibiotics Use: Yes	0 Participants	6 Participants	5 Participants
Number of Participants With Intravenous Antibiotics Use Participants with Intravenous Antibiotics Use: No	35 Participants	28 Participants	28 Participants

SECONDARY outcome

Population: The ITT analysis set included all randomized participants.

Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=34 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
All-cause Dose Reductions, Event Rate (Per Cycle)	0.133 event rate per cycle	0.141 event rate per cycle	0.118 event rate per cycle

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Dose Modifications: Number of Participants With Cycle Delays	22 Participants	17 Participants	19 Participants

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays).

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Dose Modifications - Number of Participants With Skipped Doses	13 Participants	15 Participants	20 Participants

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

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

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Dose Modifications: Number of Participants With Any Dose Interruptions Carboplatin	0 Participants	1 Participants	1 Participants
Dose Modifications: Number of Participants With Any Dose Interruptions Trilaciclib	5 Participants	NA Participants Here, 'NA' signifies that Trilaciclib drug was not administered in this specified arm.	3 Participants
Dose Modifications: Number of Participants With Any Dose Interruptions Gemcitabine	0 Participants	2 Participants	4 Participants

SECONDARY outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Dose Modifications - Number of Participants With Dose Reductions Carboplatin	15 Participants	10 Participants	13 Participants
Dose Modifications - Number of Participants With Dose Reductions Gemcitabine	17 Participants	13 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure	Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) n=35 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.	Group 1: Gemcitabine/Carboplatin (Days 1 and 8) n=30 Participants Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).	Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) n=33 Participants Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Participants with any TEAEs	34 Participants	30 Participants	33 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Participants with any Serious TEAEs	4 Participants	10 Participants	11 Participants

Adverse Events

Group 1: Gemcitabine/Carboplatin (Days 1 and 8)

Serious events: 10 serious events

Other events: 30 other events

Deaths: 25 deaths

Group 2: Trilaciclib (G1T28)+ Gemcitabine/Carboplatin (Days 1 and 8)

Serious events: 11 serious events

Other events: 33 other events

Deaths: 13 deaths

Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)

Serious events: 4 serious events

Other events: 34 other events

Deaths: 20 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Info

G1 Therapeutics, Inc

Phone: +1 9192139835

Email: [email protected]

Results disclosure agreements

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