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

Phase 2

• Conditions: Lung Adenocarcinoma
• Interventions: Drug: TKI; Radiation: Thoracic Hypofractionated Radiotherapy; Drug: Thymosin Alpha 1

• Registration Number: NCT02787447
• Lead Sponsor: First People's Hospital of Hangzhou

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-23
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25
• Primary Completion: 2017-12
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Thoracic Hypofractionated Radiotherapy	After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.
1	TKI	After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.
1	Thymosin Alpha 1	After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China