Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

A Phase II Trial of Hypofractionated Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02787447

Enrollment

Registered

2016-06-01

Start date

2016-05-31

Completion date

2020-05-31

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Adenocarcinoma

Keywords

Hypofractionated Radiotherapy, Thymosin Alpha 1, Lung Adenocarcinoma, Tyrosine Kinase Inhibitors

Brief summary

The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.

Interventions

RADIATIONThoracic Hypofractionated Radiotherapy

40-45 Gy/5-15f

DRUGTKI

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

DRUGThymosin Alpha 1

Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy) * Age 18 years or older * ECOG Performance Status 0-2 * Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter * Patients and their family signed the informed consents

Exclusion criteria

* Received chemotherapy before TKI therapy * Brain parenchyma or leptomeningeal disease * Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment * Any medical co-morbidities that would preclude radiation therapy.

Design outcomes

Primary

Measure	Time frame	Description
The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy	1-6 months	To assess the proportion of patients with an abscopal response (defined as at least a 30% decrease in the longest diameter of the best responding abscopal lesion) at 1-6 months after the radiation therapy

Secondary

Measure	Time frame	Description
To assess the short-term quality of life (QOL)	4 months	FACT-E score at the 4 months after docetaxel consolidation therapy
Rate of CTCAE grade 2 or higher radiation pneumonitis	1 years	The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy
Overall Survival	2 years	—

Countries

China

Contacts

Primary ContactShenglin Ma, MD

mashenglin@medmail.com.cn0571-56007908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026