Long-term follow up of metastatic melanoma patients treated with Thymosin alpha-1: investigating immune checkpoints synergy.
Riccardo Danielli, Filomena Cisternino, Diana Giannarelli...
https://pubmed.ncbi.nlm.nih.gov/30063847Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID07103395
A Phase II Study Evaluating Neoadjuvant Chemotherapy and Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade (PD-1/CTLA-4) in Patients With Locally Advanced Non-Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2026-01-14
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) who have not had prior cancer treatments. The study focuses on combining neoadjuvant chemotherapy with dual immune checkpoint inhibitors targeting PD-1 and CTLA-4, along with bevacizumab and thymosin alpha 1, followed by chemoradiotherapy and a consolidation phase. The goal is to assess how effective and safe this combined treatment regimen is for this patient group. Participants first receive neoadjuvant chemotherapy including albumin-bound paclitaxel or pemetrexed, cisplatin, bevacizumab, iparomlimab, tuvonralimab, and thymosin alpha 1. Then they undergo concurrent chemoradiotherapy with hypofractionated radiotherapy, concurrent chemotherapy, and surufatinib. After that, patients receive consolidation therapy for one year consisting of iparomlimab, tuvonralimab, surufatinib, and thymosin alpha 1. This phased approach is designed to comprehensively treat the cancer with multiple therapies. Throughout the study, patients are monitored for progression-free survival over two years, response rates at two months after treatment, overall survival at two years, and treatment-related side effects for about 18 months. Assessments include clinical evaluations and safety monitoring during each phase of treatment and through follow-up. Participants may be involved for up to several years depending on their progression and response to therapy, with close observation to evaluate the treatment outcomes and safety.
CONDITIONS
Brief Title
A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC)
- EGFR, ALK, and ROS1 wild-type
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy
- Expected survival of at least 12 weeks
- WHO Performance Status score of 0 or 1
- Female subjects must not be breastfeeding
- Women of childbearing potential must agree to use contraception during treatment and for 5 months after last dose
- Adequate organ and bone marrow function as defined by specific blood and lung function tests
You will not qualify if you...
- Concurrent enrollment in another clinical study, except observational studies
- Mixed small cell and non-small cell lung cancer histology
- Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies
- Recent major surgery within 4 weeks prior to study entry (except vascular access placement)
- Active or prior documented autoimmune disease within past 2 years
- Active or prior inflammatory bowel disease such as Crohn's or ulcerative colitis
- History of primary immunodeficiency or organ transplant requiring immunosuppression
- Uncontrolled illness including active infection, heart failure, hypertension, angina, arrhythmia, peptic ulcer, bleeding disorders, hepatitis B/C, HIV, or psychiatric/social conditions limiting compliance
- Known history of tuberculosis
- Another primary malignancy within 5 years, except certain treated skin or cervical cancers
- Pregnancy, breastfeeding, or no effective birth control use during study
- Development of distant metastasis or locoregional progression exceeding radiation limits during chemoradiation phase
- WHO Performance Status of 2-4 during chemoradiation phase
- Inadequate organ or marrow function during chemoradiation phase
- Progression during chemoradiation therapy
- Recent immunosuppressive medication use (except specific corticosteroids) before consolidation therapy
- Unresolved toxicities greater than Grade 2 or pneumonitis Grade 2 or higher from prior therapy
- Prior severe immune-related adverse events or unresolved immune toxicities greater than Grade 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Therapy
Duration - Not specified
Participants receive neoadjuvant chemotherapy combined with iparomlimab, tuvonralimab, and thymosin alpha 1 before radiotherapy.
Visits occur during the neoadjuvant treatment period
Concurrent Chemoradiotherapy
Duration - Not specified
Participants undergo hypofractionated radiotherapy with concurrent chemotherapy and surufatinib.
Visits occur during the chemoradiotherapy period
Consolidation Therapy
Duration - 1 year
Participants receive consolidation therapy with iparomlimab, tuvonralimab, surufatinib, and thymosin alpha 1 for maintenance.
Visits occur during the 1-year consolidation therapy
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
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Research Team
D
DaQuan Wang, MD.
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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Published Research Related To This Trial
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E Garaci, F Pica, G Rasi...
https://pubmed.ncbi.nlm.nih.gov/11137613Thymosin α1 and cancer: action on immune effector and tumor target cells.
Enrico Garaci, Francesca Pica, Annalucia Serafino...
https://pubmed.ncbi.nlm.nih.gov/23045967Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial.
Mariano Provencio, Ernest Nadal, Amelia Insa...
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Yan Huang, Yunpeng Yang, Yuanyuan Zhao...
https://pubmed.ncbi.nlm.nih.gov/38282003Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
Weishi Cheng, Kai Kang, Ailin Zhao...
https://pubmed.ncbi.nlm.nih.gov/39068460