Actively Recruiting
ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
Led by Peking Union Medical College Hospital · Updated on 2024-11-07
27
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy). This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis.
CONDITIONS
Official Title
ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign consent
- Aged between 18 and 80 years, any gender
- Confirmed stage III-IV non-small cell lung cancer
- Previously treated with first-line immunotherapy for at least 35 cycles or stable disease for at least 2 years, followed by disease progression
- Have at least one measurable tumor lesion
- ECOG performance status between 0 and 2
- Adequate organ function as defined by specific blood counts, liver and kidney tests, and coagulation parameters
- Willing and able to comply with study procedures and visits
- Agree to use effective contraception during the study and for 180 days after last dose if of childbearing potential
You will not qualify if you...
- Received two or more prior systemic therapies
- Have known sensitive EGFR mutations or ALK rearrangement
- Have symptomatic or progressing central nervous system metastases or leptomeningeal metastases
- Have a history of autoimmune disease or require systemic corticosteroids or immunosuppressive therapy (exceptions apply)
- Have idiopathic pulmonary fibrosis, drug-induced pneumonitis, or history of pneumonia/interstitial lung disease requiring steroids
- Have active tuberculosis, HIV infection, active hepatitis B or C, or other active infections needing systemic treatment
- Received systemic immunostimulatory therapy within 4 weeks before study treatment
- Are pregnant, breastfeeding, planning pregnancy, or fathering a child during the study and 180 days after
- Have had allogeneic tissue or organ transplantation or other conditions unsuitable for immunotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
M
Minjiang Chen, MD.
CONTACT
M
Mengzhao Wang, MD.
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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