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New combo aims to shield bone marrow in tough lung cancer cases

NCT ID NCT06992739

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether giving trilaciclib before sacituzumab tirumotecan can protect bone marrow in patients with advanced EGFR-mutated non-small cell lung cancer that has stopped responding to standard treatments. About 49 participants will receive the drug combo and be monitored for side effects like low blood cell counts and infections. The goal is to see if this approach reduces severe neutropenia and other blood-related toxicities.

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 Sacituzumab Tirumotecan
What this could lead to
If successful, this could show that giving trilaciclib before sacituzumab tirumotecan reduces severe side effects like low white blood cell counts, making treatment safer for patients with advanced lung cancer.
What could go wrong
This is a small, early-phase trial with only 49 participants, so results may not apply to all patients. The combination may still cause side effects or not 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 49 people

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

Started

Dec 2025

Expected to finish

Dec 2027

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 to 75 years

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. Age range: 18-75 years old; No gender restrictions; 2. ECOG PS score 0-1; 3. Expected survival time ≥ 3 months; 4. Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have failed third-generation EGFR-TKI treatment and have experienced up to second-line EGFR-TKI treatment failure; 1. Patients who have only progressed with 1-2 generations of EGFR-TKI treatment need to undergo third-generation EGFR-TKI treatment; 2. If patients receive third-generation EGFR-TKI during neoadjuvant and/or postoperative adjuvant therapy and progress to metastatic or locally advanced disease more than 6 months after the last dose, they need to receive third-generation EGFR-TKI treatment again before they can participate in this study; 3. If patients receive third-generation EGFR-TKI during neoadjuvant and/or postoperative adjuvant therapy and progress to metastatic or locally advanced disease within 6 months after the last dose, they can directly participate in this study; 4. Imaging disease progression was recorded during or after the recent first-line treatment process. 5. There must be at least one measurable lesion that meets the RECIST 1.1 criteria; 6. The main organ functions well and meets the following standards: Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 80 × 109/L; Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3×ULN); Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL/min; Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 7. The subject must recover from all toxic reactions (except hair loss) of previous treatment to ≤ level 1 (evaluated based on CTCAE 5.0 criteria); 8. Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose; 9. Participants voluntarily participate in this study, understand and sign the informed consent form. Exclusion Criteria: 1. History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease; 2. Symptomatic CNS metastases and/or leptomeningeal diseases that require immediate radiotherapy or steroid treatment; 3. Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug; 4. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 6 months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 5. History of interstitial lung disease, slow progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergic or peripheral arterial diseases (such as claudication, Leo Buerger's disease). 6. Patients who have received hematopoietic stem cell or bone marrow transplantation in the past; 7. Patients who need to receive radiation therapy at the same time; 8. Those who are known to have a history of allergies to the components of this drug regimen; 9. Pregnant or lactating women; 10. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

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