Trial Outcomes & Findings for Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4) (NCT NCT04863248)
NCT ID: NCT04863248
Last Updated: 2023-04-14
Results Overview
To assess the effects of trilaciclib administered prior to docetaxel compared with placebo administered prior to docetaxel on occurrence and severity of adverse events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, study treatment discontinuation due to adverse events (AEs), and trilaciclib adverse events of special interest (AESI) in patients with metastatic NSCLC receiving docetaxel in the second or third line.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Time from date of first dose of trilaciclib/placebo and docetaxel through 30 days following the last dose of trilaciclib/placebo and docetaxel, assessed up to 9 months and 2 days.
Results posted on
2023-04-14
Participant Flow
Due to the rapidly evolving treatment landscape for patients with metastatic NSCLC, G1 Therapeutics announced the decision to terminate this study on 03 November 2021. This study was not terminated for reasons related to safety. At the time of study termination, 10 patients had been screened, 7 were randomized, and 2 of the 7 had already discontinued from the study.
Of the 10 patients enrolled, 3 were screen failures and 7 patients were randomized to treatment.
Participant milestones
| Measure |
Trilaciclib + Docetaxel
Patients will receive trilaciclib administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Trilaciclib: Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Placebo + Docetaxel
Patients will receive placebo administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Placebo: Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Trilaciclib + Docetaxel
Patients will receive trilaciclib administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Trilaciclib: Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Placebo + Docetaxel
Patients will receive placebo administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Placebo: Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Overall Study
Sponsor Terminated
|
4
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)
Baseline characteristics by cohort
| Measure |
Trilaciclib + Docetaxel
n=4 Participants
Patients will receive trilaciclib administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Trilaciclib: Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Placebo + Docetaxel
n=3 Participants
Patients will receive placebo administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Placebo: Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Score
0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 2.52 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 8.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Score
1
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
ECOG Score
2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Stage at Diagnosis
IV
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Stage at Diagnosis
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Histopathologic Type
Adenocarcinoma
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Histopathologic Type
Squamous Cell Carcinoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from date of first dose of trilaciclib/placebo and docetaxel through 30 days following the last dose of trilaciclib/placebo and docetaxel, assessed up to 9 months and 2 days.Population: This study was terminated by the Sponsor for non-safety reasons. At the time of study termination, 10 patients had been screened, 7 were randomized, and 2 of the 7 had discontinued from the study. In addition, it was decided that there would be no statistical analyses of the efficacy or safety data due to the limited number of patients treated (N=7).
To assess the effects of trilaciclib administered prior to docetaxel compared with placebo administered prior to docetaxel on occurrence and severity of adverse events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, study treatment discontinuation due to adverse events (AEs), and trilaciclib adverse events of special interest (AESI) in patients with metastatic NSCLC receiving docetaxel in the second or third line.
Outcome measures
| Measure |
Trilaciclib + Docetaxel
n=4 Participants
Patients will receive trilaciclib administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Trilaciclib: Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Placebo + Docetaxel
n=3 Participants
Patients will receive placebo administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Placebo: Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Any AE
|
4 participants
|
3 participants
|
|
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Any AE of Grade >= 3
|
2 participants
|
3 participants
|
|
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Any AE of Grade >= 4
|
0 participants
|
3 participants
|
Adverse Events
Trilaciclib + Docetaxel
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo + Docetaxel
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Trilaciclib + Docetaxel
n=4 participants at risk
Patients will receive trilaciclib administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Trilaciclib: Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Placebo + Docetaxel
n=3 participants at risk
Patients will receive placebo administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Placebo: Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • Number of events 1 • 9 months, 2 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • Number of events 1 • 9 months, 2 days
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • Number of events 1 • 9 months, 2 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • Number of events 1 • 9 months, 2 days
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
Other adverse events
| Measure |
Trilaciclib + Docetaxel
n=4 participants at risk
Patients will receive trilaciclib administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Trilaciclib: Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
Placebo + Docetaxel
n=3 participants at risk
Patients will receive placebo administered IV no more than 4 hours prior to docetaxel administered IV on Day 1 of each 21-day cycle.
Placebo: Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
Docetaxel: Docetaxel administered IV on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4 • 9 months, 2 days
|
100.0%
3/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
2/4 • 9 months, 2 days
|
100.0%
3/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Eosinopenia
|
25.0%
1/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Investigations
Metamyelocyte count increased
|
0.00%
0/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Monocytosis
|
50.0%
2/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
1/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Neutrophilia
|
25.0%
1/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
1/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • 9 months, 2 days
|
66.7%
2/3 • 9 months, 2 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Monocytopenia
|
75.0%
3/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
2/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Investigations
Myelocyte count increased
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
Investigations
Cortisol increased
|
0.00%
0/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
General disorders
Fatigue
|
25.0%
1/4 • 9 months, 2 days
|
33.3%
1/3 • 9 months, 2 days
|
|
General disorders
Mucosal inflammation
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Investigations
Weight decreased
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
General disorders
Impaired healing
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Psychiatric disorders
Hallucination, visual
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
General disorders
Early satiety
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Vascular disorders
Phlebitis
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Metabolism and nutrition disorders
Hyperchloremia
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
25.0%
1/4 • 9 months, 2 days
|
0.00%
0/3 • 9 months, 2 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place