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

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
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
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 thymalfasin (thymosin alpha 1, ta1)