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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Adenocarcinoma
• Intervention / Treatment: Drug: TKI; Radiation: Thoracic Hypofractionated Radiotherapy; Drug: Thymosin Alpha 1

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.	Drug: TKI; Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid; Other Names: Gefitinib/Erlotinib/Icotinib; 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.; Other Names: Zadaxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		2 years
To assess the short-term quality of life (QOL)	FACT-E score at the 4 months after docetaxel consolidation therapy	4 months
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

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 23, 2016
• First Submitted That Met QC Criteria: May 31, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Estimate): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Hypofractionated Radiotherapy; Lung Adenocarcinoma; Tyrosine Kinase Inhibitors; Thymosin Alpha 1
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Protein Kinase Inhibitors; Adjuvants, Immunologic; Gefitinib; Thymalfasin
• Other Study ID Numbers: HZCH-2016-09