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Alkylating Agent

Trilaciclib + Lurbinectedin for Small Cell Lung Cancer

Phase 2
Recruiting
Led By Jared Weiss, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Previous treatment with a platinum agent, PD1 or PDL1 agent.
Must not have
Active infection requiring systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how a drug (Trilaciclib) combined with another (Lurbinectedin) affects a type of lung cancer (SCLC). The goal is to reduce side effects and improve the effectiveness of the combination.

Who is the study for?
Adults over 18 with small cell lung cancer who've had previous platinum and PD1/PDL1 treatments can join. They need measurable disease, good performance status (able to carry out daily activities), and must consent to participate. Excluded are those on recent investigational drugs, certain medications, pregnant/breastfeeding women, anyone allergic to the study drugs or their components, or with active infections needing treatment.
What is being tested?
The trial is testing Trilaciclib's ability to reduce myelosuppression (a decrease in bone marrow activity) in patients taking Lurbinectedin for extensive stage small cell lung cancer after other treatments have failed. It aims to see if combining these two drugs improves patient outcomes.
What are the potential side effects?
Lurbinectedin often causes significant side effects like myelosuppression which includes a drop in white blood cells leading to higher infection risk, anemia causing fatigue and weakness, and low platelet counts increasing bleeding risks. The impact of Trilaciclib on these side effects is being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have been treated with a platinum-based drug or drugs targeting PD1/PDL1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neutropenia
The proportion of grade 4 neutropenia
Secondary study objectives
Dose Intensity of Chemotherapy/ Number of chemotherapy cycles
Pharmacotherapy
Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trilaciclib and LurbinectedinExperimental Treatment2 Interventions
Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trilaciclib
2015
Completed Phase 4
~400
Lurbinectedin
2022
Completed Phase 3
~780

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Industry Sponsor
21 Previous Clinical Trials
3,261 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
92,691 Total Patients Enrolled
Jared Weiss, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
16 Previous Clinical Trials
505 Total Patients Enrolled

Media Library

Lurbinectedin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05578326 — Phase 2
Lung Cancer Research Study Groups: Trilaciclib and Lurbinectedin
Lung Cancer Clinical Trial 2023: Lurbinectedin Highlights & Side Effects. Trial Name: NCT05578326 — Phase 2
Lurbinectedin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05578326 — Phase 2
~9 spots leftby Dec 2025
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