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

Lung Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02787447
• Other study ID #: HZCH-2016-09
• Status: Recruiting
• Phase: Phase 2
• First received: April 23, 2016
• Last updated: November 23, 2016
• Start date: May 2016
• Est. completion date: May 2020

Study information

• Verified date: November 2016
• Source: First People's Hospital of Hangzhou
• Contact: Shenglin Ma, MD
• Phone: 0571-56007908
• Email: mashenglin[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma
• Lung Neoplasms

Intervention

Drug:
• TKI
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

Radiation:
• Thoracic Hypofractionated Radiotherapy
40-45 Gy/5-15f

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

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy	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	1-6 months	No
Secondary	To assess the short-term quality of life (QOL)	FACT-E score at the 4 months after docetaxel consolidation therapy	4 months	No
Secondary	Rate of CTCAE grade 2 or higher radiation pneumonitis	The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy	1 years	No
Secondary	Overall Survival		2 years	No