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New treatment option for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT06992739
What this study is testing
What is Trilaciclib and Sacituzumab Tirumotecan?
Trilaciclib and Sacituzumab Tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age range: 18-75 years old; No gender restrictions;
- ECOG PS score 0-1;
- Expected survival time ≥ 3 months;
- Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have...
- Patients who have only progressed with 1-2 generations of EGFR-TKI treatment need to undergo third-generation EGFR-TKI treatment;
You likely can't join if
- History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease;
- Symptomatic CNS metastases and/or leptomeningeal diseases that require immediate radiotherapy or steroid treatment;
- Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug;
- 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...
- History of interstitial lung disease, slow progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary...
- Patients who have received hematopoietic stem cell or bone marrow transplantation in the past;
See the full eligibility criteria
- Age range: 18-75 years old; No gender restrictions;
- ECOG PS score 0-1;
- Expected survival time ≥ 3 months;
- 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...
- Patients who have only progressed with 1-2 generations of EGFR-TKI treatment need to undergo third-generation EGFR-TKI treatment;
- 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...
- 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...
- Imaging disease progression was recorded during or after the recent first-line treatment process.
- There must be at least one measurable lesion that meets the RECIST 1.1 criteria;
- 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...
- The subject must recover from all toxic reactions (except hair loss) of previous treatment to ≤ level 1 (evaluated based on CTCAE 5.0 criteria);
- 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...
- Participants voluntarily participate in this study, understand and sign the informed consent form.
- History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease;
- Symptomatic CNS metastases and/or leptomeningeal diseases that require immediate radiotherapy or steroid treatment;
- Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug;
- 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...
- 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...
- Patients who have received hematopoietic stem cell or bone marrow transplantation in the past;
- Patients who need to receive radiation therapy at the same time;
- Those who are known to have a history of allergies to the components of this drug regimen;
- Pregnant or lactating women;
- The researcher believes that the patient is not suitable to participate in any other circumstances of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.