Clinical trial
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
Name
GASTO-1098
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.
Trial arms
Trial start
2023-07-25
Estimated PCD
2025-08-01
Trial end
2026-08-01
Status
Recruiting
Phase
Early phase I
Treatment
Hypofractionated radiotherapy
Participants were treated with hypofractionated radiotherapy followed by hypo-boost
Arms:
Concurrent Tα-1 group, Control group
induction chemo-immunotherapy
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.
Arms:
Concurrent Tα-1 group, Control group
Other names:
albumin-bound paclitaxel, cisplatin, tislelizumab
concurrent chemotherapy
Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2).
Arms:
Concurrent Tα-1 group, Control group
Other names:
albumin-bound paclitaxel, cisplatin
Immunotheapy consolidation
Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months.
Arms:
Concurrent Tα-1 group, Control group
Other names:
tislelizumab
Thymosin Alpha1
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.
Arms:
Concurrent Tα-1 group
Other names:
thymalfasin
Size
114
Primary endpoint
Completion rate of immunotherapy
Calculated from the start of treatment to one year after the last treatment completion
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}
Updated at
2023-11-18
1 organization
4 products
1 indication
Organization
Sun Yat-sen UniversityIndication
Lung CancerProduct
Concurrent chemotherapyProduct
ImmunotheapyProduct
Thymosin Alpha1