Actively Recruiting
Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-01
51
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
CONDITIONS
Official Title
Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent before any study procedures
- Male or female aged 18 years or older
- Primary non-squamous NSCLC confirmed by central laboratory
- Clinical stage IA2-IB with tumor size greater than 2 cm confirmed by imaging
- No common EGFR mutations or ALK fusion variants confirmed by central laboratory
- Complete surgical removal of primary NSCLC with negative margins; lobectomy via open or thoracoscopic surgery
- Tumor pathology showing solid and/or micropapillary component 10%, and/or STAS, and/or pleural invasion, and/or poorly differentiated, and/or complex glands 5 10%; PD-L1 TPS 1%
- WHO physical status score of 0 to 1
- Provide paraffin-embedded sections, wax blocks, or fresh frozen tissue from surgical lesion
- Adequate bone marrow and organ function as defined by laboratory values
- Female subjects must use highly effective contraception, have negative pregnancy tests, and not be breastfeeding at least 2 weeks before starting study drug
- Willing to comply with safety and survival follow-up and cooperate voluntarily
You will not qualify if you...
- Prior exposure to other antitumor therapies before enrollment
- Patients who only had segmental or wedge resection
- History of active autoimmune disease or autoimmune disease
- Use of immunosuppressive drugs or corticosteroids for complicated or concurrent diseases
- Severe heart disease or NYHA grade 3 or 4 cardiac insufficiency
- History or evidence of interstitial lung disease or radiation pneumonia requiring steroid treatment
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding, or active infections such as hepatitis B, hepatitis C, or HIV
- Received preventive or attenuated vaccines within 4 weeks before first administration
- Assessed as unsuitable for participation by researchers after comprehensive evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
D
Dongsheng Yue
CONTACT
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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