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

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Lung Adenocarcinoma

Treatments: Radiation: Thoracic Hypofractionated Radiotherapy; Drug: Thymosin Alpha 1; Drug: TKI

Study type: Interventional

Funder types: Other

Identifiers

NCT02787447

HZCH-2016-09

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

1

Experimental group

Description:

After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.

Treatment:

Drug: TKI

Drug: Thymosin Alpha 1

Radiation: Thoracic Hypofractionated Radiotherapy