New combo aims to shield bone marrow in tough lung cancer cases
NCT ID NCT06992739
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 49 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, Fujian, China
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Other studies related to the condition(s) this trial covers.
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- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- Can a targeted pill clear hidden lung cancer cells after surgery?
- Can a targeted drug combo boost chemoradiation in EGFR-Positive lung cancer?