A Phase 2 interventional study of Trilaciclib and Lurbinectedin in Lung Cancer and Small-cell Lung Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
Among 16 studies testing PM 01183 in Small Cell Lung Carcinoma — 9 open to participants now, 11 under way, 3 of them phase 3. PM 01183 · Small Cell Lung Carcinoma.
Among the 16 studies testing PM 01183 in Small Cell Lung Carcinoma, this one is the 12th largest by planned enrollment, is one of 2 that started in 2022, is one of 6 in phase 2, reaches primary completion later than 2 of the 10 other live ones, and was the 8th registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →9 of the 16 studies testing PM 01183 in Small Cell Lung Carcinoma are open now, in 12 countries. Each count lists the studies.
PM 01183: first FDA approval 2020 (ZEPZELCA), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →
Of the 264 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 67 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 5
First in 2013; this study’s year is marked. 2 started in 2022.
Median enrollment 69 across the 16 interventional studies. Of the 5 that completed or were terminated, 2 (40%) have results posted.
7 of 16 have an industry lead sponsor. The 10 most frequent:
UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
UNC Lineberger Comprehensive Cancer Center has 3 studies filed under Small Cell Lung Carcinoma — fewer than ten, so there is no comparison to draw.
4 of the studies testing PM 01183 in Small Cell Lung Carcinoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06501976Cancer Institute and Hospital, Chinese Academy of Medical SciencesAn Exploratory Study of Lurbinectedin With Radiotherapy in SCLC With Single-lesion Progression After First Course Treatment | 2026-12 |
| NCT05578326UNC Lineberger Comprehensive Cancer CenterStudy of Trilaciclib and Lurbinectidin | 2026-12-25 |
| NCT07640932Yonsei UniversityLurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer | 2027-04 |
| NCT06228066National Cancer Institute (NCI)Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER) | 2027-09-01 |
Among the 16 studies testing PM 01183 in Small Cell Lung Carcinoma, from their registry updates:
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.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Compared within Small Cell Lung Carcinoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Exclusion Criteria:
Active infection requiring systemic therapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin
Drug: Trilaciclib · Drug: Lurbinectedin
240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle
3.2 mg/m2, over 60 minutes at day 1 of each cycle
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.
Time frame: 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.
Time frame: Up to 21 days
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Not enrolling at this site.
Started Oct 2022 (actual). Primary completion is estimated for Dec 2026, 50 months after the start.
Of 150 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 87. This study's planned 50 months is close to that.
Counting every sponsor, half of 203 studies reached it within 47 months; a quarter within 29 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Trilaciclib · PM 01183
UNC Lineberger Comprehensive Cancer Center →