Trial · Interventional

CompletedPhase 2Registry data

The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC

NCTNCT06139419Other idGASTO-1098

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 114 participants (actual)
Sponsor: Sun Yat-sen University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 25 Jul 2023
Primary completion: 30 Jun 2026
Completion: 30 Jun 2026
First posted: 18 Nov 2023
Last update posted: 3 Aug 2026
Conditions: Non-small Cell Lung Cancer

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024202520262027

Ph 2
The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC
NCT06139419
25 Jul 2023 to 30 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

definitive radiotherapyRadiation
induction chemo-immunotherapyDrug
concurrent chemotherapyDrug
Immunotheapy consolidationDrug
Thymosin Alpha1Drug

Arms2

Experimental
Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
Other
Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.

Primary outcomes1

Outcomes the sponsor listed as primary.

Completion rate of immunotherapy
Time frame · Calculated from the start of treatment to one year after the last treatment completion
Registry description
Proportion of participants completing 12 months of consolidation of immutherapy

Secondary outcomes(7)

Overall survival
Time frame · 2 years
Progression-free survival
Time frame · one year
Incidence of ≥grade 2 pneumonia
Time frame · through study completion, an average of 1 year
Drop-out rate during the I/O consolidation
Time frame · One year
The absolute count of total lymphocyte in peripheral blood
Time frame · Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Registry description
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
The expression of peripheral blood cytokines (including IL2, IL4, IL6, IL10, TNF-α, and IFN-γ)
Time frame · Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Registry description
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.
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
Time frame · Calculated from the start of treatment to one year after the last treatment completion; up to 18 months
Registry description
Measured at baseline, before immunotherapy, and every 3-4 months thereafter until the end of immunotherapy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Clinical trial · 2022

6 results

Efficacy of Thymosin α1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043).

Liu et al. 2022International journal of radiation oncology, biology, physicscited by 26

PMID 35870709DOI 10.1016/j.ijrobp.2022.07.009PUB-35870709

Full text at the publisher6 results

Publisher page See results (6)

PubMed tag: none · 2018

2 results

Long-term follow up of metastatic melanoma patients treated with Thymosin alpha-1: investigating immune checkpoints synergy.

Danielli et al. 2018Expert opinion on biological therapycited by 20

PMID 30063847DOI 10.1080/14712598.2018.1494717PUB-30063847

Full text at the publisher2 results

Publisher page See results (2)

Indexing hint: Randomized controlled trial · 2013

4 results

The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.

Wu et al. 2013Critical care (London, England)cited by 105

PMID 23327199PMC4056079DOI 10.1186/cc11932PUB-23327199

CC BY4 results

Download PDF See results (4)

Indexing hint: Review · 2012

1 result

Thymosin α1 and cancer: action on immune effector and tumor target cells.

Garaci et al. 2012Annals of the New York Academy of Sciencescited by 62

PMID 23045967DOI 10.1111/j.1749-6632.2012.06697.xPUB-23045967

Full text at the publisher1 result

Publisher page See results (1)

Indexing hint: Animal study · 2004

7 results

Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through toll-like receptor signaling.

Romani et al. 2004Bloodcited by 164

PMID 14982877DOI 10.1182/blood-2003-11-4036PUB-14982877

Rights unknown7 results

Source link See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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