Actively Recruiting
Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression
Led by Ruijin Hospital · Updated on 2024-11-18
29
Participants Needed
2
Research Sites
301 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
G
Guangdong Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression.
CONDITIONS
Official Title
Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 65 18 years old
- Tumor tissue obtained by biopsy or surgery at study center
- Histologically confirmed primary non-small cell lung cancer of non-squamous type
- Clinical stage II to IIIB (excluding N3 disease) with verified curative resectability
- EGFR mutations confirmed by central laboratory (sensitive, uncommon, or complex mutations)
- PD-L1 tumor proportion score 65 1% by central laboratory, with enrollment balanced between high (65 50%) and low (1-49%) expression
- No prior systemic treatment for NSCLC
- ECOG performance status 0-1
- Expected survival of at least 3 months
- Adequate blood and organ function
You will not qualify if you...
- Squamous cell carcinoma, combined small cell carcinoma, or large cell carcinoma
- Confirmed ALK translocation
- Prior systemic cancer therapy for current lung cancer (chemotherapy, radiotherapy, targeted therapy, ablation, or other local/systemic therapy)
- Previous malignancies except certain in situ cancers or non-melanoma skin cancers unless complete remission for at least 2 years
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressive medications (except some controlled conditions)
- History of interstitial lung disease, pneumonitis, or poorly controlled lung disease
- Severe chronic or active infections requiring systemic treatment, including tuberculosis
- Untreated chronic hepatitis B or HBV carriers with high viral load
- Known active hepatitis C virus infection
- Known HIV positive status
- High bleeding risk or active hemoptysis
- Allergy to study drug components
- Pregnant or lactating women
- Fertile men or female partners unwilling to use contraception
- Medical, mental, or psychological conditions preventing study completion or understanding
- Factors increasing medication risk or confounding outcome judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
2
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hecheng Li, PhD, MD
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