Actively Recruiting
Phase II Study of Sacituzumab Tirumotecan Combined With Furmonertinib in Patients With Locally Advanced or Metastatic Non-squamous NSCLC Who Progressed After EGFR-TKI and Platinum-Based Chemotherapy
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-04-23
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of combining sacituzumab tirumotecan with furmonertinib in patients who have locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with specific EGFR mutations. These patients have experienced progression after treatment with EGFR-TKI therapies and platinum-based chemotherapy. The study builds on previous findings that showed promising benefits with similar drug combinations in this patient population. Participants receive sacituzumab tirumotecan at a dose of 5 mg/kg through intravenous infusion on days 1 and 15 of each treatment cycle, along with daily oral doses of furmonertinib mesylate at 80 mg. The study will monitor patients over a period of up to 24 months to assess progression-free survival, overall survival, response rates, duration of response, quality of life, and safety. Throughout the study, participants will undergo regular assessments including tumor tissue or biopsy for biomarker analysis, laboratory tests to monitor organ and cardiac function, and questionnaires to evaluate quality of life. Safety and treatment responses will be closely monitored up to 24 months. The study requires patients to have adequate organ function and an ECOG performance status of 0 or 1, with expected survival beyond six months, ensuring they can comply with study procedures and visits.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years who have signed informed consent
- Histologically or cytologically confirmed non-squamous NSCLC, locally advanced (Stage IIB/IIC) or metastatic (Stage IV), not suitable for curative surgery or chemoradiotherapy
- Presence of EGFR-sensitive mutations (19del and L858R) confirmed by tissue or blood genetic testing
- Prior EGFR-TKI therapy with documented treatment failure and progression after first-, second-, or third-generation EGFR-TKI as specified
- Prior platinum-based chemotherapy or chemotherapy intolerance
- ECOG performance status of 0 or 1 with expected survival over 6 months
- Agree to provide previously stored tumor tissue or undergo biopsy for biomarker analysis
- Adequate organ function as defined by specific laboratory test thresholds
- Left ventricular ejection fraction (LVEF) ≥50%
- Ability to communicate effectively and comply with study procedures
You will not qualify if you...
- Squamous cell carcinoma, small cell lung cancer, or mixed histologies
- Symptomatic brain metastases at treatment start; asymptomatic brain metastases allowed if stable for at least 4 weeks
- Participation in other interventional oncology trials during or within 30 days before first-line therapy
- History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months
- Severe cardiovascular or cerebrovascular diseases, including recent myocardial infarction or stroke, significant arrhythmias, or heart failure class II or above
- Uncontrolled systemic diseases such as poorly controlled diabetes or hypertension
- Symptomatic pleural, pericardial effusion, or ascites requiring frequent drainage
- History or current interstitial lung disease or pneumonitis requiring steroid treatment
- Significant pulmonary impairment or autoimmune diseases involving the lungs
- Active gastrointestinal diseases like inflammatory bowel disease, obstruction, ulcers, or bleeding
- Tumor invasion of vital organs or risk of fistula development
- Unresolved toxicities from prior anti-tumor therapy above Grade 1
- Known hypersensitivity to study drugs or components
- Women of childbearing potential and men unwilling to use effective contraception during and for 6 months after treatment
- Active hepatitis B or C infection
- Positive HIV test or active syphilis infection
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive sacituzumab tirumotecan by intravenous infusion on Days 1 and 15 of each cycle, combined with daily oral furmonertinib mesylate.
Visits for drug administration on Days 1 and 15 of each cycle with additional visits for assessments approximately every 6 weeks
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
H
haiyan Sun
Z
Zhanyu Pan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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