Study of Trilaciclib and Lurbinectidin

Description

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

Study Overview

Study Details

Study overview

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 of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Study of Trilaciclib and Lurbinectidin

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Lebanon

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UNC Lineberger Comprehensive Cancer Center,

Jared Weiss, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

2027-12-25