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New combo aims to tame Chemo's worst side effect in deadly lung cancer

NCT ID NCT05578326

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether adding trilaciclib to the chemotherapy drug lurbinectedin can reduce severe neutropenia (a dangerous drop in white blood cells) in people with small cell lung cancer that has spread. About 30 participants will receive both drugs intravenously. The study focuses on safety and how well the combination works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trilaciclib and lurbinectedin
What this could lead to
If successful, this combination could reduce dangerous side effects (severe neutropenia) from chemotherapy and improve treatment tolerance for small cell lung cancer patients.
What could go wrong
This is a small Phase 2 trial with only 30 participants, so results may not apply broadly. The drugs may still cause significant side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm neutropenia small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer Small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dartmouth Hitchcock Medical Center

    WITHDRAWN

    Lebanon, New Hampshire, 03756, United States

  • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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