Actively Recruiting
MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2023-03-17
60
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Zhengzhou University
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC
CONDITIONS
Official Title
MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed primary NSCLC, postoperative stage IIA, IIB, IIIA, or T3N2IIIB
- Complete tumor resection performed
- Availability of 10-15 paraffin-embedded tissue sections or fresh frozen tissue
- ECOG performance status of 0 or 1
- Females of childbearing potential must use contraception from screening until 3 months after treatment and have a negative pregnancy test before dosing
- Male patients must use barrier contraception from screening until 3 months after treatment
- Voluntary participation with signed informed consent
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors or systemic immunotherapy (e.g., anti-PD-1, PD-L1, CTLA-4, interferon, IL-2, TNF)
- Presence of small cell or large cell endocrine tumor components
- Presence of EGFR sensitizing mutation or ALK gene translocation
- History of other malignant tumors except effectively treated non-melanoma skin cancer, carcinoma in situ, or solid tumors without disease for over 5 years
- Ongoing toxicities from prior treatments greater than CTCAE grade 1, except alopecia or grade 2 neurotoxicity from chemotherapy
- Serious or uncontrolled systemic disease including uncontrolled hypertension, active bleeding, active infections (hepatitis B, C, HIV), or other conditions affecting study compliance
- History or evidence of interstitial lung disease, drug-induced lung disease, or radiation pneumonitis requiring steroids
- Insufficient bone marrow or organ function
- Known hypersensitivity to tislelizumab or similar drugs
- Any condition judged by the investigator to impair patient safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University,
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
F
Feng Li, MD
CONTACT
Y
Yu Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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