Study of Trilaciclib and Lurbinectidin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2027-12-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer Small-cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trilaciclib and Lurbinectedin

Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin

Group Type EXPERIMENTAL

Trilaciclib

Intervention Type DRUG

240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle

Lurbinectedin

Intervention Type DRUG

3.2 mg/m2, over 60 minutes at day 1 of each cycle

Interventions

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Trilaciclib

240 mg/m2 intravenous, over 30 minutes at day 1 of each cycle

Intervention Type DRUG

Lurbinectedin

3.2 mg/m2, over 60 minutes at day 1 of each cycle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No