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Report for Clinical Trial NCT02787447

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02787447 Lung Adenocarcinoma
MeSH:Adenocarcinoma Adenocarcinoma of Lung

3 Interventions

Name: TKI

Description: Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Type: Drug
Group Labels: 1


Name: Thoracic Hypofractionated Radiotherapy

Description: 40-45 Gy/5-15f
Type: Radiation
Group Labels: 1


Name: Thymosin Alpha 1

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


Primary Outcomes

Description: 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

Measure: The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy

Time: 1-6 months

Secondary Outcomes

Description: FACT-E score at the 4 months after docetaxel consolidation therapy

Measure: To assess the short-term quality of life (QOL)

Time: 4 months

Description: The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy

Measure: Rate of CTCAE grade 2 or higher radiation pneumonitis

Time: 1 years

Measure: Overall Survival

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 L858R

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. --- L858R ---

HPO Nodes