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RecruitingPhase 2

Study of Trilaciclib and Lurbinectidin

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether trilaciclib can reduce low blood cell counts caused by lurbinectedin and how well the two drugs work together. It is for people with small cell lung cancer that has spread widely and does not respond to platinum-based cancer drugs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Sign a form agreeing to join the study and allow the use of personal health information.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have cancer that can be measured using study rules within 28 days before treatment starts.
  • Have had treatment with a platinum-based cancer drug and a PD1 or PDL1 drug, which helps the immune system fight cancer.

Who can't join

  • Have an active infection that needs treatment that works throughout the body.
  • Be pregnant or breastfeeding. Breast milk cannot be saved for later use during study treatment.
  • Have received an experimental drug within 4 weeks before study treatment starts.
  • Have a known allergy or sensitivity to either study drug or any of its ingredients.
  • Be receiving medicines or treatments that the study rules do not allow.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. * 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.

Study sites (2)

NC

NH