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New treatment option for NSCLC Stage IV
Official title A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy
ClinicalTrials.gov ID: NCT07548060
What this study is testing
What is sacituzumab tirumotecan?
sacituzumab tirumotecan is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for nsclc stage iv.
Also referred to as furmonertinib.
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
- Efficacy and Safety of Sacituzumab Tirumotecan Combined with Furmonertinib in Patients with Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy.
- 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
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) and not amenable to...
- people must have received prior EGFR-TKI therapy for locally advanced or metastatic disease and experienced treatment failure (documented...
- Male or female people aged ≥18 years and ≤75 years who have signed the informed consent form.
- ECOG performance status of 0 or 1, with an expected survival \>6 months.
- Agree to provide previously stored tumor tissue specimens or undergo biopsy to collect tumor lesion tissue for biomarker analysis.
You likely can't join if
- Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); small cell lung cancer (including combined small cell and...
- Patients with symptomatic brain metastases at the start of treatment (patients with previously treated brain metastases are eligible if asymptomatic...
- Patients who participated in an treatment oncology clinical trial concurrently during first-line therapy or within 30 days prior to first-line...
- History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months before treatment initiation.
- Patients with severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA)...
- Uncontrolled systemic diseases as determined by the investigator:
See the full eligibility criteria
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage Ⅳ) and not amenable to curative surgery and/or curative concurrent/sequential chemoradiotherapy...
- people must have received prior EGFR-TKI therapy for locally advanced or metastatic disease and experienced treatment failure (documented radiographic disease progression), and must meet one of the following...
- Male or female people aged ≥18 years and ≤75 years who have signed the informed consent form.
- ECOG performance status of 0 or 1, with an expected survival \>6 months.
- Agree to provide previously stored tumor tissue specimens or undergo biopsy to collect tumor lesion tissue for biomarker analysis.
- Adequate organ function: Laboratory tests must meet the following requirements: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, hemoglobin ≥90 g/L, white blood cell count ≥3.0×10\^9/L; Liver...
- Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); small cell lung cancer (including combined small cell and non-small cell lung cancer); patients who have previously received...
- Patients with symptomatic brain metastases at the start of treatment (patients with previously treated brain metastases are eligible if asymptomatic brain metastases persist for at least 4 weeks while on stable dose...
- Patients who participated in an treatment oncology clinical trial concurrently during first-line therapy or within 30 days prior to first-line therapy.
- History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months before treatment initiation.
- Patients with severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction within 6 months before enrollment, and significant...
- Uncontrolled systemic diseases as determined by the investigator:
- Poorly controlled diabetes (fasting blood glucose ≥10 mmol/L on two consecutive occasions);
- Poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg);
- Presence of symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (\>1 time/week).
- History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis at...
- Clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months before first dosing, severe asthma...
- people with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding.
- Tumor invasion of surrounding vital organs and vessels (such as heart, esophagus, superior vena cava, etc.) or risk of developing tracheoesophageal fistula or esophagopleural fistula.
- Toxicities from prior anti-tumor therapy that have not recovered to ≤Grade 1 (based on NCI CTCAE version 5.0 assessment) or to the level specified in inclusion/exclusion criteria (except for alopecia, fatigue, and other...
- Known or suspected hypersensitivity to furmonertinib and sacituzumab tirumotecan and/or other components of their formulations.
- Women of childbearing potential or male people who are unwilling to use effective contraception during the study or for 6 months after the last dose of study drug.
- Active hepatitis B (positive hepatitis B surface antigen (HBsAg) requiring HBV-DNA testing; HBV-DNA ≥500 IU/mL or higher than the lower limit of detection, whichever is higher) or hepatitis C (positive hepatitis C...
- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- Other conditions that the investigator considers unsuitable for enrollment in addition to the above situations.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 Tianjin, Tianjin Municipality, 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.