Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Cisplatin

Thymalfasin

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Adjuvants, Immunologic

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Arm A: 70 patients will receive Thymosin alpha 1 in 1mL SC injection five times a week (first four months); then two times a week for eight months. SoC chemotherapy and cisplatin (or carboplatin) for twelve months.

Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months.

Patients will be randomized to Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.

Thymalfasin (Thymosin alpha 1, Ta1)

Patients will be randomized to SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.

SoC (chemotherapy and platinum agent)

Carlo Tomino, MD

Dott.ssa Teresa Gamucci

Dott.ssa Marina Chiara Garassino

Prof. Daniele Santini

Prof. Carlo Antonio Mario Barone

Dott. Francesco Angelini

Prof. Mario Roselli

Prof. Paolo Marchetti

Dott.ssa Maria Rita Migliorino

Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type

Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type

Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) Chemotherapy Plus Cisplatin (or Carboplatin) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type

SciClone Pharmaceuticals

Rare Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Amino Acids

Tyrosine Kinase Inhibitors

Erlotinib Hydrochloride

Gefitinib

Protein Kinase Inhibitors

Tyrosine

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

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

Thoracic Hypofractionated Radiotherapy

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

Thymosin Alpha 1

Shenglin Ma, MD

Shirong Zhang, Dr.

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.

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

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

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

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

First People's Hospital of Hangzhou

Molgramostim

Sargramostim

Metastasis lesion will be treated with a SBRT of 50Gy/4-10F from day 1 to day 10 . Subcutaneous injection of Immunological Agent- human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Subcutaneous injection of another Immunological Factors Thymosin Alpha 1(1.6mg Biw)will be executed from the fist WEEK to the 12th Weeks.

Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion

SBRT

Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.

Immunological Agent

Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.

Immunological Factors

Deng Chong, MD

Lin Qin, MD/PhD

Ye Feng, MD

An Hanxiang, MD/PhD

Liu Qun, MD

The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.

Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be conducted at the end of therapy and every month after that. Adverse events will be recorded according to NCI-CTC version 4.03.

SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

A Prospective Multi-center Phase II Study: Assessment of the Safety and Abscopal Effects of SBRT Combination With rhGM-CSF and Thymosin Alpha 1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

The First Affiliated Hospital of Xiamen University

Infections

Symptoms and General Pathology

Small Cell Lung Carcinoma

Pneumonia

Communicable Diseases

Respiratory Tract Infections

Small Cell Lung Cancer

Acute Graft Versus Host Disease

Docetaxel

Nedaplatin

Patients are treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.

Concurrent chemotherapy

Patient was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost

split-course radiotherapy

subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

thymosin alpha 1

This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.

This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation pneumonitis in non-small cell lung cancer with bulky tumor.

All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost. Patients were further treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. Toxicities will be graded according to CTCAE v. 4.0.

Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

A Phase II Study of Thymopeptide a1 During Split-course Chemoradiotherapy to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Radiation-induced pneumonitis except other reasons induced pneumonia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type	NCT02906150	Non-Small Cell ...	Thymalfasin (Th... SoC (chemothera...	18 Years -	SciClone Pharmaceuticals
Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy	NCT02787447	Lung Adenocarci...	TKI Thoracic Hypofr... Thymosin Alpha ...	18 Years - 75 Years	First People's Hospital of Hangzhou
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type	NCT02906150	Non-Small Cell ...	Thymalfasin (Th... SoC (chemothera...	18 Years -	SciClone Pharmaceuticals
SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy	NCT02976740	Lung Cancer Met...	SBRT Immunological A... Immunological F...	17 Years - 70 Years	The First Affiliated Hospital of Xiamen University
Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer	NCT03659578	Non-small Cell ...	Concurrent chem... split-course ra... thymosin alpha ...	18 Years - 75 Years	Sun Yat-sen University
SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy	NCT02976740	Lung Cancer Met...	SBRT Immunological A... Immunological F...	17 Years - 70 Years	The First Affiliated Hospital of Xiamen University
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type	NCT02906150	Non-Small Cell ...	Thymalfasin (Th... SoC (chemothera...	18 Years -	SciClone Pharmaceuticals
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type	NCT02906150	Non-Small Cell ...	Thymalfasin (Th... SoC (chemothera...	18 Years -	SciClone Pharmaceuticals

Spots Global Cancer Trial Database for thymosin alpha 1