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

NCT02787447 | Unknown Phase 2 DMC

• 1 other identifier: HZCH-2016-09
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  1-6 months

Secondary Outcomes (3)

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

  4 months

• Rate of CTCAE grade 2 or higher radiation pneumonitis

  1 years

• Overall Survival

  2 years

Study Arms (1)

1

EXPERIMENTAL

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

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

Interventions

TKI DRUG

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

Also known as: Gefitinib/Erlotinib/Icotinib

1

Thoracic Hypofractionated Radiotherapy RADIATION

40-45 Gy/5-15f

1

Thymosin Alpha 1 DRUG

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

Also known as: Zadaxin

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Gefitinib; Thymalfasin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Central Study Contacts

Shenglin Ma, MD

CONTACT

0571-56007908; mashenglin@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: June 1, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2020
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

CN (1)