No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for adults with small cell lung cancer who have received prior treatments. Participants will take Trilaciclib along with Lurbinectedin to see how these medications work together and impact side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have given my written consent to participate.
I have a performance status of 0-1.
I have measurable disease based on recent evaluations.
I have received treatment with a platinum agent or PDL1 agent.
You may not be able to join if
I have an active infection that needs treatment.
I am pregnant or breastfeeding.
I have taken any investigational drug in the last 4 weeks.
I am allergic to either study medication.
I am taking medications that are not allowed in the trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
* 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…
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.