Metastatic Non-Small Cell Lung CancerPhase 2PRESERVE 4NCT04863248
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4)
A Phase 2 study testing Trilaciclib and Docetaxel in people with Metastatic Non-Small Cell Lung Cancer and NSCLC, run by G1 Therapeutics, Inc. at 12 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial evaluating the effect of trilaciclib on overall survival when administered prior to docetaxel in patients with metastatic NSCLC treated in the 2nd or 3rd line setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer, NSCLC, Lung Cancer
- What is being tested?
- Trilaciclib and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Apr 2021to 2 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age at the time of signing the informed consent.
- Histologically or cytologically confirmed metastatic NSCLC (squamous or nonsquamous) with no known actionable driver mutations (eg, EGFR, ROS1, ALK).
- Patients must have had documented disease progression during or after 1 or 2 lines of systemic treatment for recurrent or metastatic disease.
- Two components of treatment must have been received in the same line or as separate lines of therapy: (i) a maximum of 1 line of platinum-containing chemotherapy regimen for recurrent/metastatic disease, and (ii) a maximum of 1 line of a locally approved/authorized PD-1/PD-L1 mAb containing regimen for recurrent/metastatic disease.
- Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate line of therapy. Maintenance therapy is defined as therapy given within 42 days after the last dose of platinum-based chemotherapy in patients with ongoing clinical benefit (complete response [CR], partial response [PR] or stable disease [SD]).
- Measurable or non-measurable disease per RECIST v1.1.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting NSCLC must be available to send to the Sponsor, within the specified timeframe, for planned retrospective biomarker analyses.
- Adequate organ function defined by the normal laboratory values.
Who cannot join
- Prior therapy with docetaxel.
- Any contraindication to the administration of docetaxel at the discretion of the investigator.
- Mixed NSCLC/SCLC, or lung tumors whose predominant histology is sarcomatoid, or neuroendocrine.
- Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate-specific antigen (PSA) persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.
- Any radiotherapy within 2 weeks prior to the first dose of trilaciclib/placebo.
- Presence of central nervous system (CNS) metastases requiring immediate treatment with radiation therapy or steroids (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo).
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- Presence of leptomeningeal disease.
- Significant third-space fluid retention (eg, ascites or pleural effusion) not amenable to required repeat drainage.
- QT corrected using Fridericia's formula (QTcF) interval >480 msec at screening (confirmed on repeat). For patients with ventricular pacemakers, QTcF >500 msec.
- Symptomatic peripheral neuropathy.
- History of interstitial lung disease (ILD).
- Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
St. Louis Cancer Care, LLP
Bridgeton, Missouri, 63044
Summit Medical Group
Florham Park, New Jersey, 07932
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Indiana University Health Goshen Cancer Center
Goshen, Indiana, 46526
Millennium Oncology
Houston, Texas, 77090
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Regional Cancer Car Associates, LLC
Little Silver, New Jersey, 07739
Valkyrie Clinical Trials
Los Angeles, California, 90067
Mid-Florida Hematology Oncology
Orange City, Florida, 32763
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, 92270
Innovative Clinical Research Institute - Oncology
Whittier, California, 90602
About this study
Official title: A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib Versus Placebo in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4)
This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial evaluating the effect of trilaciclib on overall survival when administered prior to docetaxel in patients with metastatic NSCLC treated in the 2nd or 3rd line setting.
Read the detailed description
Patients must have documented disease progression during or after one or two lines of systemic therapy for recurrent or metastatic NSCLC. Prior treatment must have included, either in the same line or as separate lines of therapy: 1) a maximum of 1 line of platinum-containing chemotherapy for recurrent/metastatic disease and 2) a maximum of 1 line of a locally approved/authorized programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) containing regimen for recurrent/metastatic disease.
Patients will be randomly assigned (1:1) to receive trilaciclib or placebo intravenously (IV) prior to docetaxel on Day 1 of each 21-day cycle.
The study will include a screening phase, a treatment phase and a survival follow-up phase. The patient may continue to receive treatment on study until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first.
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).
- Conditions
- Metastatic Non-Small Cell Lung Cancer, NSCLC, Lung Cancer
- Being tested
- Trilaciclib, Placebo, Docetaxel
- Keywords
- Trilaciclib, Lung Cancer, Non-Small Cell Lung Cancer, PRESERVE 4, CDK 4/6 Inhibitor, cyclin-dependent kinase 4/6 inhibitor, Preserve, NSCLC, solid tumors, chemotherapy, metastatic, myeloprotection, advanced, stage 4, lung, docetaxel, COSELA, G1T28
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called COSELA, G1T28
Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
PlaceboDrug
Also called 0.9% sodium chloride, 5% Dextrose in water (D5W)
Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
DocetaxelDrug
Also called Taxotere, Docefrez
Docetaxel administered IV on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| trilaciclib + docetaxel | Experimental | Patients will receive trilaciclib administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle. Receives: Drug: Trilaciclib; Drug: Docetaxel |
| placebo + docetaxel | Placebo comparator | Patients will receive placebo administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle. Receives: Drug: Placebo; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start30 Apr 2021
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Why it stopped: Treatment paradigm in second- and third-line NSCLC is shifting away from docetaxel, the backbone chemotherapy therapy used in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- G1 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Contact, Study director, G1 Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863248
- Sponsor's protocol ID
- G1T28-210
- Other IDs
- 2021-000186-32
- Acronym
- PRESERVE 4
- Status last verified
- Jan 2023
- First submitted
- 16 Apr 2021
- Last updated
- 14 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib Versus Placebo in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4)
- ClinicalTrials.gov ID
- NCT04863248
- Acronym / sponsor ID
- PRESERVE 4 / G1T28-210
- Conditions
- Metastatic Non-Small Cell Lung Cancer, NSCLC, Lung Cancer
- Keywords
- Trilaciclib, Lung Cancer, Non-Small Cell Lung Cancer, PRESERVE 4, CDK 4/6 Inhibitor, cyclin-dependent kinase 4/6 inhibitor, Preserve, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment paradigm in second- and third-line NSCLC is shifting away from docetaxel, the backbone chemotherapy therapy used in this study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- G1 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Posted 14 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 trial evaluating the effect of trilaciclib on overall survival when administered prior to docetaxel in patients with metastatic NSCLC treated in the 2nd or 3rd line setting.
Detailed description
Patients must have documented disease progression during or after one or two lines of systemic therapy for recurrent or metastatic NSCLC. Prior treatment must have included, either in the same line or as separate lines of therapy: 1) a maximum of 1 line of platinum-containing chemotherapy for recurrent/metastatic disease and 2) a maximum of 1 line of a locally approved/authorized programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) containing regimen for recurrent/metastatic disease.
Patients will be randomly assigned (1:1) to receive trilaciclib or placebo intravenously (IV) prior to docetaxel on Day 1 of each 21-day cycle.
The study will include a screening phase, a treatment phase and a survival follow-up phase. The patient may continue to receive treatment on study until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trilaciclib + docetaxel | Experimental | Drug: Trilaciclib, Drug: DocetaxelPatients will receive trilaciclib administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle. |
| placebo + docetaxel | Placebo comparator | Drug: Placebo, Drug: DocetaxelPatients will receive placebo administered IV prior to docetaxel administered IV on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years of age at the time of signing the informed consent.
- Histologically or cytologically confirmed metastatic NSCLC (squamous or nonsquamous) with no known actionable driver mutations (eg, EGFR, ROS1, ALK).
- Measurable or non-measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting NSCLC must be available to send to the Sponsor, within the specified timeframe, for planned retrospective biomarker analyses.
Key exclusion criteria (12 listed)
- Prior therapy with docetaxel.
- Any contraindication to the administration of docetaxel at the discretion of the investigator.
- Mixed NSCLC/SCLC, or lung tumors whose predominant histology is sarcomatoid, or neuroendocrine.
- Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or prostate-specific antigen (PSA) persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.
- Any radiotherapy within 2 weeks prior to the first dose of trilaciclib/placebo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrilaciclibAlso: COSELA, G1T28Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle. | Drug | trilaciclib + docetaxel |
| PlaceboAlso: 0.9% sodium chloride, 5% Dextrose in water (D5W)Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle. | Drug | placebo + docetaxel |
| DocetaxelAlso: Taxotere, DocefrezDocetaxel administered IV on Day 1 of each 21-day cycle. | Drug | placebo + docetaxel, trilaciclib + docetaxel |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Contact study director
G1 Therapeutics, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trilaciclib and Docetaxel in people with Metastatic Non-Small Cell Lung Cancer and NSCLC, run by G1 Therapeutics, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.