Actively Recruiting
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy
Led by Guangdong Association of Clinical Trials · Updated on 2026-05-05
120
Participants Needed
4
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.
CONDITIONS
Official Title
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not suitable for surgery or radical radiotherapy
- Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R)
- Completion of 3-week first-line osimertinib monotherapy without disease progression and willingness to undergo ctDNA testing
- At least one measurable target lesion per RECIST v1.1
- ECOG Performance Status of 0 or 1 within 7 days before enrollment
- Adequate organ and bone marrow function, including specific blood counts and liver, kidney, and coagulation parameters
- Use of effective contraception during treatment and for 6 months after dosing for subjects of childbearing potential
- Willingness to sign informed consent and comply with study procedures
You will not qualify if you...
- Presence of squamous cell carcinoma component or other lung cancer types such as small cell lung cancer or neuroendocrine carcinoma
- Known meningeal, brainstem, spinal cord metastases, or active brain metastases
- Prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib
- Previous treatment with any TROP2-targeted therapy or topoisomerase I-targeted therapy
- Other malignancies within 3 years except certain cured local tumors
- Cardiovascular or cerebrovascular diseases or risk factors within defined recent timeframes
- Uncontrolled systemic diseases such as poorly controlled diabetes or hypertension
- History or current pneumonitis/interstitial lung disease requiring steroids or suspected by imaging
- Severe eye conditions or corneal disease affecting healing
- Severe lung impairment or prior pneumonectomy
- Active gastrointestinal diseases affecting drug absorption or metabolism
- Tumor invasion or compression causing related symptoms or risk of fistula
- Unrecovered toxicities from prior anti-tumor therapy above grade 1
- Recent serious or active infections including tuberculosis and hepatitis B or C
- Positive HIV test or history of AIDS or active syphilis
- History of allogeneic organ or stem cell transplantation
- Major surgery within 4 weeks before enrollment or expected during study
- Known allergy to study drugs or severe hypersensitivity to monoclonal antibodies
- Use of medications affecting cytochrome P450 3A4 that cannot be stopped before treatment
- Recent radiotherapy exceeding specified doses before enrollment
- Live vaccines within 30 days prior or planned during study
- Rapid disease deterioration before first dose
- Pregnant or lactating women
- Any other condition judged by investigator to interfere with study participation or data interpretation
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
Meizhou People's Hospital (Huangtang Hospital), Meizhou Academy of Medical Sciences
Meizhou, Guangdong, China, 514031
Actively Recruiting
3
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515041
Actively Recruiting
4
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
Q
Qing Zhou
CONTACT
Y
Yi-Chen Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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