Lung CancerPhase 2NCT05578326
Study of Trilaciclib and Lurbinectidin
A Phase 2 study testing Trilaciclib and Lurbinectedin in people with Lung Cancer and Small-cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small-cell Lung Cancer
- What is being tested?
- Trilaciclib and Lurbinectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2022to 25 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Measurable disease according to RECIST v1.1 within 28 days prior to start of treatment.
- Previous treatment with a platinum agent, PD1 or PDL1 agent.
Who cannot join
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Treatment with any investigational drug within 4 weeks prior to start of treatment.
- A known allergy or sensitivity to either study drug or its excipients.
- Subject is receiving prohibited medications or treatments as listed in the protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Jared Weiss, MD, 919-843-7718, jared_weiss@med.unc.edu
Lauren Higgins, lqhiggin@ad.unc.edu
- Withdrawn
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer
Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression.
This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.
- Conditions
- Lung Cancer, Small-cell Lung Cancer
- Being tested
- Trilaciclib, Lurbinectedin
- Keywords
- Lurbinectedin, Trilaciclib, myelosuppression, neutropenia
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle
LurbinectedinDrug
3.2 mg/m2, over 60 minutes at day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib and Lurbinectedin | Experimental | Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin Receives: Drug: Trilaciclib; Drug: Lurbinectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of grade 4 neutropenia
The proportion of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be determined.
CTCAE is descriptive terminology that can be used for Adverse Event (AE) grading and reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 21 days
The duration of grade 4 neutropenia
The median duration of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be reported.
Measured: Up to 21 days
Secondary outcomes (13)
The mean duration of grade 4 neutropenia
The mean duration of grade 4 neutropenia in cycle 1 will be defined as the start of grade 4 neutropenia to the time of decreased grade as measured in days or censored at the time of death if a subject dies with Grade 4 neutropenia in Cycle 1.
Measured: Up to 21 days
The number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia
Toxicity will be evaluated, as the number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria, in any cycle (including cycle 1).
Measured: Up to 8 months
Use of secondary/reactive supportive measures
To characterize use of secondary/reactive supportive measures any supportive measures such as Granulocyte colony-stimulating factor ( G-CSF) and erythropoietin stimulating agents (ESA) administration, red blood cell and platelet transfusion will be recorded.
Measured: Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions
The dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions will be defined as the ratio of the subjects who required chemotherapy dose reductions to all subjects who received study treatment.
Measured: Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy cycles
The dose Intensity of Chemotherapy/ Number of chemotherapy cycles will be defined as the median number of chemotherapy cycles among the subject who received study treatment.
Measured: Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy delays
The dose Intensity of Chemotherapy/ Number of chemotherapy delays will be defined as the median number of chemotherapy cycle delays dates among the subject who received study treatment.
Measured: Up to 8 months
Dose Intensity of Chemotherapy/ the total chemotherapy dose
The dose Intensity of Chemotherapy/ the total chemotherapy dose will be defined as the median chemotherapy dose among the subject who received study treatment.
Measured: Up to 8 months
Overall Response Rate (ORR)
To estimate the ORR, the proportion of subjects that respond (CR + PR) will be measured according to RESIST 1.1 will be calculated.
RECIST: Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if the subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 5 years
Progression-free survival (PFS)
PFS will be measured from the initiation of study therapy until progression per RECIST 1.1 or death of any cause or at last date of disease assessment if no progression is observed during the study period.
Measured: Up to 5 years
Overall survival (OS)
OS will be measured from the initiation of therapy until death of any cause or censored at the last time known to be alive.
Measured: Up to 5 years
The kinetics of response
The kinetics of response will be reported as tumor size over time for all patients, including the pace of progression from prior therapy.
Measured: Up to 5 years
QOL assessments FACT-L
Scores from QOL assessments FACT-L version 4, from prior to study therapy through cycle 12 will be obtained, as described in the protocol.
The FACT-L is a lung cancer specific subscale given at baseline, after each cycle and at end of treatment. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Measured: Up to 5 years
QOL assessments FACT-An
Scores from QOL assessments FACT-An version 4, from prior to study therapy through cycle 12 will be obtained, as described in the protocol.
The FACT-An is an anemia specific subscale given at baseline, after each cycle and at end of treatment. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start12 Oct 2022
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- G1 Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578326
- Sponsor's protocol ID
- LCCC2117
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05578326
- Acronym / sponsor ID
- LCCC2117
- Conditions
- Lung Cancer, Small-cell Lung Cancer
- Keywords
- Lurbinectedin, Trilaciclib, myelosuppression, neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- G1 Therapeutics, Inc.
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2028 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression.
This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib and Lurbinectedin | Experimental | Drug: Trilaciclib, Drug: LurbinectedinSubjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Measurable disease according to RECIST v1.1 within 28 days prior to start of treatment.
- Previous treatment with a platinum agent, PD1 or PDL1 agent.
Key exclusion criteria (5 listed)
- Active infection requiring systemic therapy.
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 |
|---|---|---|
| Trilaciclib240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle | Drug | Trilaciclib and Lurbinectedin |
| Lurbinectedin3.2 mg/m2, over 60 minutes at day 1 of each cycle | Drug | Trilaciclib and Lurbinectedin |
Primary outcome
The proportion of grade 4 neutropenia
Time frame: Up to 21 days
The proportion of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be determined. CTCAE is descriptive terminology that can be used for Adverse Event (AE) grading and reporting. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
The duration of grade 4 neutropenia
Time frame: Up to 21 days
The median duration of subjects that experience grade 4 neutropenia as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be reported.
13 secondary outcomes
The mean duration of grade 4 neutropenia
Time frame: Up to 21 days
The number of grade 3/4 anemia, grade 3/4 thrombocytopenia, and febrile neutropenia
Time frame: Up to 8 months
Use of secondary/reactive supportive measures
Time frame: Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions
Time frame: Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy cycles
Time frame: Up to 8 months
Dose Intensity of Chemotherapy/ Number of chemotherapy delays
Time frame: Up to 8 months
Dose Intensity of Chemotherapy/ the total chemotherapy dose
Time frame: Up to 8 months
Overall Response Rate (ORR)
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
The kinetics of response
Time frame: Up to 5 years
QOL assessments FACT-L
Time frame: Up to 5 years
QOL assessments FACT-An
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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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.
Jared Weiss, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
2 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 Lurbinectedin in people with Lung Cancer and Small-cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamina Williams (919-966-4432, shamina_williams@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of grade 4 neutropenia (time frame: Up to 21 days). The study lists 2 primary outcomes in all. 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 21 Sep 2026.