NCT02787447

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2020-05-01
• First posted: 2016-06-01
• Last updated: 2016-11-25

Locations

1 site across 1 country: China