Actively Recruiting
The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China
Led by Guangdong Association of Clinical Trials · Updated on 2020-02-27
100
Participants Needed
1
Research Sites
552 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Several published clinical trials have shown the superiority of immunotherapy in neoadjuvant setting. Here we conducted this real world study to see whether neoadjuvant immunotherapy would bring MPR and survival benefits in NSCLC, for example, single agent immunotherapy or immunotherapy combination with chemotherapy. Furthermore biomarker analysis would be also performed to achieve personalized neoadjuvant immunotherapy.
CONDITIONS
Official Title
The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent provided
- Male or female aged 18 years or older
- Able to follow study procedures and attend follow-up visits
- Pathologically diagnosed with potentially resectable non-small cell lung cancer stage II-IIIA (TNM 8th edition)
- Measurable disease according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- PD-L1 expression status does not affect eligibility
- Negative for EGFR mutation and ALK translocation
- Pulmonary function adequate for lobectomy or pneumonectomy
You will not qualify if you...
- Positive for EGFR mutation or ALK translocation
- Active central nervous system metastases
- Active, known, or suspected autoimmune disease (except certain controlled conditions like vitiligo or type I diabetes mellitus)
- Use of systemic corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressive drugs within 14 days before enrollment
- Symptomatic interstitial lung disease (Grade 3-4) or poor lung function
- Concurrent active malignancy requiring treatment or investigational therapies
- History of other malignancies unless remission achieved at least 2 years prior and no current treatment needed
- Medical, mental, or psychological conditions that would prevent study completion or understanding of information
- Prior treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, CTLA-4, or related pathways
- Active hepatitis B or C infection
- Known HIV/AIDS infection
- Allergy to study drug components
- Pregnant or breastfeeding women
- Sexually active individuals of childbearing potential unwilling to use effective contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
S
Si-Yang Liu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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