Study of Trilaciclib and Lurbinectidin

Official title

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

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.

Interventions

• Drug Trilaciclib
  240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle
• Drug Lurbinectedin
  3.2 mg/m2, over 60 minutes at day 1 of each cycle

Primary outcome measures

• The proportion of grade 4 neutropenia [Time frame: Up to 21 days]
• The duration of grade 4 neutropenia [Time frame: Up to 21 days]

Secondary outcome measures (12)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Dartmouth Hitchcock Medical Center — Lebanon
• Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill — Chapel Hill

Identifiers

NCT: NCT05578326 · LCCC2117

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗