Actively Recruiting
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
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-04-23
25
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage IIB/IIC) or metastatic (Stage IV) not suitable for curative surgery or chemoradiotherapy, with EGFR-sensitive mutations (19del and L858R).
- Prior treatment with EGFR-TKI therapy for advanced disease with documented progression and either T790M-negative after first/second-generation EGFR-TKI or progression after third-generation EGFR-TKI and platinum chemotherapy or intolerance.
- Male or female aged 18 to 75 years who have signed informed consent.
- ECOG performance status 0 or 1, with expected survival over 6 months.
- Agree to provide stored tumor tissue or undergo biopsy for biomarker analysis.
- Adequate organ function as defined by specific laboratory test thresholds for blood counts, liver, renal, coagulation, and cardiac function.
- Able to communicate effectively and comply with study requirements.
You will not qualify if you...
- Squamous cell carcinoma or small cell lung cancer or prior systemic therapy except adjuvant/neoadjuvant.
- Symptomatic brain metastases at treatment start; stable asymptomatic brain metastases are allowed.
- Participation in another interventional oncology trial during or within 30 days before first-line therapy.
- History of tracheoesophageal fistula, gastrointestinal perforation or abscess within 6 months.
- Severe cardiovascular or cerebrovascular diseases including recent heart attack, stroke, unstable angina, or significant heart rhythm abnormalities.
- 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 steroids or suspected but unruled out by imaging.
- Significant pulmonary impairment or autoimmune diseases involving lungs.
- Active chronic inflammatory bowel disease or severe gastrointestinal conditions.
- Tumor invasion of vital organs or risk of fistula formation.
- Unresolved toxicities from prior treatments above grade 1 except alopecia or fatigue.
- Known hypersensitivity to study drugs or components.
- Women of childbearing potential or men unwilling to use contraception during and 6 months after study.
- Active hepatitis B or C infection, positive HIV or active syphilis.
- Other investigator-determined unsuitable conditions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Z
Zhanyu Pan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here