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

Primary Purpose

Lung Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

TKI

Thoracic Hypofractionated Radiotherapy

Thymosin Alpha 1

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring Hypofractionated Radiotherapy, Thymosin Alpha 1, Lung Adenocarcinoma, Tyrosine Kinase Inhibitors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Rate of CTCAE grade 2 or higher radiation pneumonitis

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

Overall Survival

Full Information

NCT ID

NCT02787447

First Posted

April 23, 2016

Last Updated

November 23, 2016

Sponsor

First People's Hospital of Hangzhou

1. Study Identification

Unique Protocol Identification Number

NCT02787447

Brief Title

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

Official Title

A Phase II Trial of Hypofractionated Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First People's Hospital of Hangzhou

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Adenocarcinoma

Keywords

Hypofractionated Radiotherapy, Thymosin Alpha 1, Lung Adenocarcinoma, Tyrosine Kinase Inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TKI

Other Intervention Name(s)

Gefitinib/Erlotinib/Icotinib

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Thoracic Hypofractionated Radiotherapy

Intervention Description

40-45 Gy/5-15f

Intervention Type

Drug

Intervention Name(s)

Thymosin Alpha 1

Other Intervention Name(s)

Zadaxin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1-6 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 months

Title

Rate of CTCAE grade 2 or higher radiation pneumonitis

Description

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

Time Frame

1 years

Title

Overall Survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shenglin Ma, MD

Phone

0571-56007908

Ext

086

mashenglin@medmail.com.cn

Facility Information:

Facility Name

Hangzhou First People's Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shirong Zhang, Dr.

Phone

086057156007650

shirley4444@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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