Actively Recruiting
ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
Led by Sun Yat-sen University · Updated on 2026-04-23
80
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after adjuvant therapy. Toripalimab is a humanized monoclonal antibody for human programmed cell death protein 1. Toripalimab was approved as a consolidation treatment after perioperative therapy in combination with chemotherapy for resectable stage III NSCLC.
CONDITIONS
Official Title
ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Complete surgical removal (R0) of stage IB, II, or select IIIA NSCLC according to AJCC 8th edition
- Squamous or non-squamous NSCLC without EGFR or ALK alterations for nonsquamous type
- Male or female aged 18 to 75 years
- Surgery completed within 60 days before starting study treatment
- ECOG performance status of 0 or 1
- Adequate blood counts: neutrophils 2.0 x 10^9/L, platelets 100 x 10^9/L, hemoglobin 9 g/dL
- Adequate liver function: bilirubin 1.5 x upper limit of normal, AST and ALT 2.5 x upper limit of normal
- Adequate kidney function: serum creatinine 1.25 x upper limit of normal or glomerular filtration rate 3 ml/min
- Female participants must not be pregnant or breastfeeding
- Signed informed consent and willingness to follow study procedures
You will not qualify if you...
- Incomplete tumor removal (not R0) or metastatic disease
- Known EGFR sensitive mutations or ALK translocation in nonsquamous NSCLC
- Previous systemic antitumor treatment for NSCLC
- Severe allergic reactions to monoclonal antibodies
- Known or suspected autoimmune disorders or immunodeficiency, except well-controlled hypothyroidism or type I diabetes
- Active uncontrolled hepatitis B or hepatitis C infection
- Live vaccine received within 30 days before first dose
- Active interstitial lung disease
- Known HIV infection or AIDS
- Unable to comply with study procedures
- Unstable systemic diseases including infections, tuberculosis, heart disease, or metabolic disorders
- Serious other systemic disorders compromising study participation
- History of other cancers within 5 years except certain cured skin or cervical cancers
- Pregnant or nursing women
- Mixed small cell lung cancer patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
S
Si-Yu Wang, MD
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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