Clinical trial NCT06139419: The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC
Official title: A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Thymosin alpha-1
concurrent chemoradiotherpay
immunotherapy consolidation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Completion rate of immunotherapy
timeFrame: Calculated from the start of treatment to one year after the last treatment completion
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progression-free survival
timeFrame: one year
measure: Incidence of ≥grade 2 pneumonia
timeFrame: through study completion, an average of 1 year
measure: Drop-out rate during the I/O consolidation
timeFrame: One year
measure: The absolute count of total lymphocyte in peripheral blood
timeFrame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
measure: The expression of peripheral blood cytokines (including IL2, IL4, IL6, IL10, TNF-α, and IFN-γ)
timeFrame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
measure: The absolute count of peripheral blood lymphocyte subsets (including CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, and CD56+ NK cells, PD-1+CD8+ T cells, Tim3+ CD8+ T cells, CD62lowCD4+ T cells, PD-1+CD4+ T cells, and Tim3+CD4+ T cells
timeFrame: Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen university cancer center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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