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New drug combo aims to extend life in tough lung cancer

NCT ID NCT05874401

Disease control Sponsor: Pharmacosmos A/S 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether adding trilaciclib before standard chemotherapy (topotecan) can help people with extensive-stage small cell lung cancer live longer. About 302 participants will receive either trilaciclib or a placebo before their chemo, and researchers will compare overall survival. The trial is double-blind, meaning neither patients nor doctors know who gets the real drug.

What this could mean

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

Active substance
Trilaciclib (a drug given before chemotherapy to protect healthy cells)
What this could lead to
If it works, this could show that trilaciclib helps people with advanced small cell lung cancer live longer or have better outcomes when combined with standard chemotherapy.
What could go wrong
This is a Phase 4 trial, but it's testing non-inferiority (whether trilaciclib is at least as good as placebo). The drug may not improve survival, and side effects from chemotherapy remain a risk.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 302 people

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

Started

Oct 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Inclusion Criteria: 1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology 2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination. 3. Measurable or evaluable disease as defined by RECIST v1.1 Exclusion Criteria: 1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC 2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer 3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids 4. Radiotherapy within 2 weeks 5. History of ILD/pneumonitis 6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

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

Extensive-stage small-cell lung cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Hospital

    RECRUITING

    Seville, Spain

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