Trial Outcomes & Findings for Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab (NCT NCT04887831)

NCT ID: NCT04887831

Last Updated: 2025-09-08

Results Overview

The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks
• Results posted on: 2025-09-08

Participant Flow

This study was conducted at 55 sites in the United States (US), Hungary, Georgia, France, and Spain from 4 June 2021 (first participant enrolled) to 1 March 2024 (last participant last visit).

Of the 116 participants enrolled, 24 were screen failures and 92 participants were randomized to treatment.

Participant milestones

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Overall Study STARTED	47	45
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	47	45

Reasons for withdrawal

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Overall Study Death	26	26
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	1
Overall Study Study Terminated by Sponsor	18	17
Overall Study Other	1	0

Baseline Characteristics

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Baseline characteristics by cohort

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Age, Continuous	67.8 years STANDARD_DEVIATION 10.34 • n=5 Participants	67.3 years STANDARD_DEVIATION 8.40 • n=7 Participants	67.6 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks

Population: The Intent-to-treat (ITT) analysis set included all randomized participants.

The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Number of Participants With Progression-Free Survival (PFS) During Overall Study	36 Participants	34 Participants

SECONDARY outcome

Timeframe: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks

Population: The Response Evaluable (RE) analysis set included those participants who were in the ITT population and received at least 1 dose of any study drug, have measurable (target) tumor lesion(s) at baseline tumor assessment, and have at least 1 of the following: (1) at least 1 post-baseline tumor assessment; (2) discontinued treatment because of clinical progression prior to their first post-baseline tumor scan; (3) died due to disease progression prior to their first post-baseline tumor scan.

The ORR defined as the percentage of participants who had an objective response (unconfirmed or confirmed) per RECIST v1.1

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=46 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Number of Participants With Objective Response Rate (ORR) During Chemotherapy Period	24 Participants	19 Participants

SECONDARY outcome

Timeframe: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks

Population: The RE analysis set included those participants who were in the ITT population and received at least 1 dose of any study drug, have measurable (target) tumor lesion(s) at baseline tumor assessment, and have at least 1 of the following: (1) at least 1 post-baseline tumor assessment; (2) discontinued treatment because of clinical progression prior to their first post-baseline tumor scan; (3) died due to disease progression prior to their first post-baseline tumor scan.

The ORR defined as the percentage of participants who had an objective response (unconfirmed or confirmed) per RECIST v1.1

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=46 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Number of Participants With Objective Response Rate During Overall Treatment Period	24 Participants	23 Participants

SECONDARY outcome

Timeframe: From date of randomization (Day 1) up to Month 12

Population: The ITT analysis set included all randomized participants.

The OS during the study was defined as the time from the date of randomization to the date of death for participants who died in the study regardless of cause, or to the last contact date known to be alive for those who survived as of the date of data snapshot for intermediate planned analysis or final database lock for final analyses (censored cases).

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Percentage of Participants Survived at 12 Months [Overall Survival (OS) Rate]	64.6 Percentage Of - Participants	54.0 Percentage Of - Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (each cycle is 21 days) through treatment with platinum-based chemotherapy, approximately up to 4 months

Population: The ITT analysis set included all randomized participants.

To assess the effects of trilaciclib on the neutrophil lineage as measured by the occurrence of severe neutropenia during platinum-based chemotherapy treatment. Myeloprotective effects protect the blood-forming cells in the bone marrow from the side effects of chemotherapy such as bone marrow suppression.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Myeloprotective Effects	0.8 Duration of severe neutropenia (days) Standard Deviation 2.88	0.5 Duration of severe neutropenia (days) Standard Deviation 2.00

SECONDARY outcome

Timeframe: From date of randomization, up to 12 cycles (21-day each) of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the participant or investigator, assessed up to 34 weeks.

Population: The maintenance population included all the randomized participants who received at least 1 dose of any study drug during the maintenance period.

The DCR was defined as the percentage of participants with best overall response (BOR) of confirmed CR, confirmed PR, or SD.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=29 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=30 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Disease Control Rate (DCR) During Maintenance Period	44.8 Percentage of participants Interval 26.4 to 64.3	26.7 Percentage of participants Interval 12.3 to 45.9

SECONDARY outcome

Timeframe: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks

Population: The RE analysis set included those participants who were in the ITT population and received at least 1 dose of any study drug, have measurable (target) tumor lesion(s) at baseline tumor assessment, and have at least 1 of the following: (1) at least 1 post-baseline tumor assessment; (2) discontinued treatment because of clinical progression prior to their first post-baseline tumor scan; (3) died due to disease progression prior to their first post-baseline tumor scan.

The DCR was defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or SD.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=46 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Disease Control Rate During Overall Study	89.1 percentage of participants Interval 76.4 to 96.4	82.2 percentage of participants Interval 67.9 to 92.0

SECONDARY outcome

Timeframe: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks

Population: The RE analysis set included those participants who were in the ITT population and received at least 1 dose of any study drug, have measurable (target) tumor lesion(s) at baseline tumor assessment, and have at least 1 of the following: (1) at least 1 post-baseline tumor assessment; (2) discontinued treatment because of clinical progression prior to their first post-baseline tumor scan; (3) died due to disease progression prior to their first post-baseline tumor scan.

The DoR was defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=46 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Duration of Response (DoR), Overall Study	6.6 Months Interval 3.3 to 8.3	7.0 Months Interval 4.7 to 15.6

SECONDARY outcome

Timeframe: From date of randomization, up to 12 cycles (21-day each) of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the participant or investigator, assessed up to 34 weeks.

Population: The maintenance population included all the randomized participants who received at least 1 dose of any study drug during the maintenance period.

The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=29 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=30 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Number of Participants With Progression-Free Survival During Maintenance Period	22 Participants	20 Participants

SECONDARY outcome

Timeframe: 16 months

Population: The ITT analysis set included all randomized participants.

The OS was defined as the time from the date of randomization to the date of death for participants who died in the study regardless of cause, or to the last contact date known to be alive for those who survived as of the date for final database lock (censored cases).

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Percentage of Participants With Probability of Survival at 16 Months.	44.5 percentage of participants Interval 29.8 to 58.2	46.9 percentage of participants Interval 31.5 to 60.8

SECONDARY outcome

Timeframe: From date of randomization, up to 12 cycles (21-day each) of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the participant or investigator, assessed up to 34 weeks.

Population: The maintenance population included all the randomized participants who received at least 1 dose of any study drug during the maintenance period.

The OS was calculated as the time (months) from date of randomization to the date of death due to any cause.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=29 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=30 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Overall Survival During Maintenance Period	13 Participants	17 Participants

SECONDARY outcome

Timeframe: From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.

Population: The ITT analysis set included all randomized participants.

The OS was calculated as the time (months) from date of randomization to the date of death due to any cause.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Overall Survival During Overall Study	14.6 months Interval 10.5 to CI upper limit for the median OS could not be estimated due to an insufficient number of patients with events as a result of insufficient follow-up time and censoring due to early study termination.	15.4 months Interval 10.2 to CI upper limit for the median OS could not be estimated due to an insufficient number of patients with events as a result of insufficient follow-up time and censoring due to early study termination.

SECONDARY outcome

Timeframe: From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.

Population: The Safety Population included all randomized participants who received at least 1 dose of any study drug.

An AE was defined as any untoward or unfavourable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Number of Participants With Adverse Events (AE)	45 Participants	44 Participants

SECONDARY outcome

Timeframe: From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.

Population: The Safety Population included all randomized participants who received at least 1 dose of any study drug.

SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect.

Outcome measures

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 Participants Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 Participants Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Number of Participants With Serious Adverse Events (SAE)	13 Participants	18 Participants

Adverse Events

Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy

Serious events: 13 serious events

Other events: 45 other events

Deaths: 26 deaths

Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy

Serious events: 18 serious events

Other events: 44 other events

Deaths: 26 deaths

Serious adverse events

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 participants at risk Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 participants at risk Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Nervous system disorders Optic Neuritis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Immune system disorders Immue-mediated adverse reaction	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Asthenia	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Sepsis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Flank Pain	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Septic Shock	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Endocrine disorders Inappropriate antidiuretic hormone secretion	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Pancreatitis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Psychiatric disorders Confusional state	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Febrile neutropenia	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscle necrosis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Ureterolithiasis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal failure	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Urosepsis	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebral thrombosis	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Pain	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Blood creatinine increased	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Klebsiella infection	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Platelet count decreased	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Bacteraemia	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Urinary tract stoma complication	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.

Other adverse events

Measure	Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=47 participants at risk Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Avelumab (800 mg) Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle	Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy n=45 participants at risk Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg) Trilaciclib: Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered. Gemcitabine: Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle Cisplatin: Cisplatin administered IV on Day 1 of each 21-day cycle Carboplatin: Carboplatin administered IV on Day 1 of each 21-day cycle Avelumab: Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Blood and lymphatic system disorders Anaemia	59.6% 28/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	55.6% 25/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Neutropenia	34.0% 16/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	28.9% 13/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombocytopenia	21.3% 10/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	17.8% 8/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Leukopenia	10.6% 5/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Asthenia	27.7% 13/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	28.9% 13/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Fatigue	21.3% 10/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	22.2% 10/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Pyrexia	10.6% 5/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Oedema peripheral	10.6% 5/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Pain	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	8.9% 4/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
General disorders Mucosal inflammation	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	38.3% 18/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	48.9% 22/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Constipation	27.7% 13/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	15.6% 7/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diarrhoea	12.8% 6/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	11.1% 5/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	8.5% 4/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	15.6% 7/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dry mouth	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	2.2% 1/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Platelet count decreased	21.3% 10/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	8.9% 4/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Neutrophil count decreased	19.1% 9/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	8.9% 4/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Blood creatinine increased	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	11.1% 5/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Blood alkaline phosphatase increased	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Investigations Weight decreased	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	19.1% 9/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	31.1% 14/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypomagnesaemia	19.1% 9/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypokalaemia	8.5% 4/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	12.8% 6/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypocalcaemia	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	8.9% 4/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypophosphataemia	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	8.9% 4/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperkalaemia	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19	8.5% 4/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	8.5% 4/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Infections and infestations Respiratory tract infection	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	0.00% 0/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	17.8% 8/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	15.6% 7/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Nervous system disorders Dysgeusia	14.9% 7/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	8.5% 4/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Nervous system disorders Neuropathy peripheral	4.3% 2/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	8.9% 4/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Alopecia	6.4% 3/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	11.1% 5/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Pruritus	2.1% 1/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Psychiatric disorders Insomnia	12.8% 6/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	11.1% 5/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Ear and labyrinth disorders Tinnitus	8.5% 4/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	4.4% 2/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.6% 5/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.6% 5/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	10.6% 5/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	11.1% 5/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal failure	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	13.3% 6/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal impairment	0.00% 0/47 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.	6.7% 3/45 • From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks. The Safety Population included all randomized participants who received at least 1 dose of any study drug.

Additional Information

Clinical Trial Info.

G1 Therapeutics, Inc.

Phone: 919-213-9835

Email: clinicalinfo@g1therapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator agrees to submit any disclosure to Sponsor for review at least thirty (30) days prior to submission. Within sixty (60) days of its receipt, Sponsor can provide feedback on any disclosure Sponsor may require Investigator to remove, Confidential Information (other than study data), and/or to delay the proposed publication or presentation for an additional sixty (60) days to enable Sponsor to seek patent protection for inventions.
• Publication restrictions are in place

Restriction type: OTHER