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Trial Title:
The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC
NCT ID:
NCT06139419
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Tislelizumab
Thymalfasin
Conditions: Keywords:
non-small cell lung cancer
Thymosin alpha-1
concurrent chemoradiotherpay
immunotherapy consolidation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
definitive radiotherapy
Description:
Participants were treated with definitive thoracic radiotherapy
Arm group label:
Concurrent Tα-1 group
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
induction chemo-immunotherapy
Description:
All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and
cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1.
Arm group label:
Concurrent Tα-1 group
Arm group label:
Control group
Other name:
albumin-bound paclitaxel
Other name:
cisplatin
Other name:
tislelizumab
Intervention type:
Drug
Intervention name:
concurrent chemotherapy
Description:
Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and
cisplatin (25mg/m2).
Arm group label:
Concurrent Tα-1 group
Arm group label:
Control group
Other name:
albumin-bound paclitaxel
Other name:
cisplatin
Intervention type:
Drug
Intervention name:
Immunotheapy consolidation
Description:
Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2
pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.
Arm group label:
Concurrent Tα-1 group
Arm group label:
Control group
Other name:
tislelizumab
Intervention type:
Drug
Intervention name:
Thymosin Alpha1
Description:
Participants in the Tα1 treatment group will receive Tα1 from the beginning of induction
chemo-immunotherapy until the completion of immunotherapy consolidation. In detail, Tα-1
would be administered according to the following three stages:
1. Induction chemo-immunotherapy: Tα-1 will be subcutaneously administered at 4.8 mg on
d1 and d3 for each cycle.
2. Concurrent chemoradiotherapy: Tα-1 will be subcutaneously administered at 4.8mg
biweekly.
3. Immunotherpay consolidation: Tα-1 will be administered concurrently with
tislelizumab at 4.8mg (Q3W) for up to 12 months.
Arm group label:
Concurrent Tα-1 group
Other name:
thymalfasin
Summary:
This prospective phase II randomized study is to determine the impact of thymosin alpha-1
on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients
with locally advanced NSCLC by assessing the survival outcomes, treatment responses and
toxicities.
Detailed description:
This prospective phase II randomized study is to determine the impact of thymosin alpha-1
on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients
with locally advanced NSCLC by assessing the survival outcomes, treatment responses and
toxicities.
Patients with locally advanced NSCLC who will receive concurrent radiochemotherapy
followed by immunotherapy consolidation will be randomly divided into two groups
(concurrent Tα1 treatment group and control group [in which Tα1 will not be used]), and
the overall survivals, progression-free survivals (PFS), completion rate of immunotherapy
consolidation, toxicities/adverse effects, and peripheral blood immune biomarkers will be
compared between these two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- aged ≥18 years old
- histologically confirmed locally advanced and unresectable NSCLC;
- no prior radiotherapy or surgery;
- with the life expectancy over 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- adequate bone marrow and hepatic and renal functions;
- informed consent
Exclusion Criteria:
- Concurrent enrollment in another clinical trial, unless it is an observational
(non-interventional) clinical study;
- With histologically documented combined small-cell lung carcinoma;
- Major surgery (excluding vascular access placement) within 4 weeks prior to
enrollment in the study;
- Active or prior documented autoimmune disease within the past 2 years;
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease,
ulcerative colitis);
- History of innate immunodeficiency;
- History of organ transplant that requires the use of immunosuppressives;
- A mean heart rate-corrected QT interval (QTc) ≥ 470 ms, calculated using Bazett
correction from 3 ECG calculation cycles;
- Poorly managed health conditions that include but are not limited to persistent or
active infections, symptomatic congestive heart failure, poorly controlled
hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis,
active hemorrhagic diseases, hepatitis C or human immunodeficiency virus (HIV)
infection, hepatitis B (positive HBsAg and HBV DNA > 500 IU/ml), and mental
disorders/social conditions that may hinder the compliance with the study
requirements or the ability to give written informed consent willingly;
- Active tuberculosis;
- Receipt of live or attenuated vaccination within 30 days prior to the first dose of
the investigational agents;
- History of another primary malignancy within the past 5 years, excluding adequately
treated basal or squamous cell skin cancers or cervical carcinoma in situ;
- Pregnant/breastfeeding women or males/females of reproductive potential who do not
use contraception.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun yat-sen university cancer center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Liu, Professor
Phone:
+86-020-87343031
Email:
liuhui@sysucc.org.cn
Start date:
July 25, 2023
Completion date:
August 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139419
