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

NCT ID: NCT02787447

Last Updated: 2016-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

TKI

Intervention Type: DRUG

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

Thoracic Hypofractionated Radiotherapy

Intervention Type: RADIATION

40-45 Gy/5-15f

Thymosin Alpha 1

Intervention Type: DRUG

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

Interventions

TKI

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

Intervention Type: DRUG

Thoracic Hypofractionated Radiotherapy

40-45 Gy/5-15f

Intervention Type: RADIATION

Thymosin Alpha 1

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

Intervention Type: DRUG

Other Intervention Names

Gefitinib/Erlotinib/Icotinib; Zadaxin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shenglin Ma, MD

Role: CONTACT

mashenglin@medmail.com.cn

0571-56007908 ext. 086

Facility Contacts

Shirong Zhang, Dr.

Role: primary

shirley4444@gmail.com

086057156007650

Other Identifiers

HZCH-2016-09

Identifier Type: -

Identifier Source: org_study_id