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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neutropenia

The proportion of grade 4 neutropenia

Secondary outcome measures

Dose Intensity of Chemotherapy/ Number of chemotherapy cycles

Pharmacotherapy

Dose Intensity of Chemotherapy/ Number of chemotherapy dose reductions

+10 more

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

~280

Lurbinectedin

2022

Completed Phase 2

~90

0 / 2Eligibility criteria met

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

351 Previous Clinical Trials

88,303 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

Small Cell Lung Cancer Research Study Groups: Trilaciclib and Lurbinectedin

Small Cell 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has either Trilaciclib or Lurbinectedin gained regulatory approval?

"Our team at Power has rated the safety profile of Trilaciclib and Lurbinectedin as a 2, given that we are still in Phase 2. This implies there is some data affirming its security but none suggesting it's efficacy."

Answered by AI

What is the aggregate count of people participating in this experiment?

"Indeed. According to information accessible on clinicaltrials.gov, this trial is currently recruiting participants for participation. It was initially posted online on October 12th 2022 and the most recent update was made on November 9th of that same year. 30 patients will be enrolled from a single site for an assessment of efficacy and safety."

Answered by AI

What are the core aims of this investigation?

"This medical trial will span up to 21 days and aim to measure the duration of grade 4 neutropenia. Secondary objectives include an analysis of median number of chemotherapy cycle delays, recordation of any secondary or reactive supportive measures (e.g., G-CSF/ESA administration, RBC/platelet transfusion), and characterization of the total administered chemotherapy dose among study participants."

Answered by AI

Are there opportunities for enrolment in this medical trial?

"Indeed, clinicaltrials.gov confirms that this research is currently recruiting participants and has been open for applications since October 12th 2022 (last edited on November 9th 2022)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Trilaciclib and Lurbinectidin

2022. "Study of Trilaciclib and Lurbinectidin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05578326.

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