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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Lung Adenocarcinoma

Keywords

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Hypofractionated Radiotherapy Thymosin Alpha 1 Lung Adenocarcinoma Tyrosine Kinase Inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Gefitinib/Erlotinib/Icotinib Zadaxin

Eligibility Criteria

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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

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First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shenglin Ma, MD

Role: CONTACT

Phone: 0571-56007908

Email: [email protected]

Facility Contacts

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Shirong Zhang, Dr.

Role: primary

Other Identifiers

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HZCH-2016-09

Identifier Type: -

Identifier Source: org_study_id