Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02906150
Recruitment Status : Unknown
Verified September 2016 by SciClone Pharmaceuticals.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
SciClone Pharmaceuticals

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Thymalfasin (Thymosin alpha 1, Ta1) Drug: SoC (chemotherapy and platinum agent) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thymalfasin (Thymosin alpha 1, Ta1)
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.
Drug: Thymalfasin (Thymosin alpha 1, Ta1)
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.
Other Name: ZADAXIN

Drug: SoC (chemotherapy and platinum agent)
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.
Other Name: Pemetrexed, carboplatin or cisplatin

Active Comparator: SoC (chemotherapy and platinum agent)
Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months.
Drug: SoC (chemotherapy and platinum agent)
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.
Other Name: Pemetrexed, carboplatin or cisplatin




Primary Outcome Measures :
  1. Time to progression free survival (PFS) [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study (see major details in section 8 for the minimum sample characteristics)
  • Activating mutations of EGFR diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastatic NSCLC, not amenable to curative surgery or radiotherapy
  • Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) in a lesion not previously irradiated or non-measurable disease (non measurable disease only for Phase I)
  • Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2
  • Absolute neutrophil count (ANC) > 1.5 x 109/liter (L) and platelets > 100 x 109/L
  • Bilirubin level either normal or <1.5 x ULN
  • AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤ 5 x ULN if liver metastases are present)
  • Serum creatinine <1.5 x ULN
  • Effective contraception for both, male and female patients, if the risk of conception exists
  • Provision of written informed consent to the analysis of biological markers (registration)

Exclusion Criteria:

  • Prior therapy with Thymosin alpha-1
  • Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation
  • Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies
  • Radiotherapy within 14 days prior to drug administration, except as follows:
  • Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
  • Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling
  • Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days
  • Patients with toxicities that have not come back (at least) to grade 1
  • Pregnancy or suspected pregnancy
  • Known severe hypersensitivity to TKI products
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • As judged by the investigator, any inflammatory changes of the surface of the eye
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906150


Contacts
Layout table for location contacts
Contact: Carlo Tomino, MD carlotomino@gmail.com

Locations
Layout table for location information
Italy
Azienda Sanitaria Locale Frosinone
Frosinone, Italy
Contact: Dott.ssa Teresa Gamucci         
Principal Investigator: Dott.ssa Teresa Gamucci         
Istituto Nazionale dei Tumori
Milan, Italy
Contact: Dott.ssa Marina Chiara Garassino         
Principal Investigator: Dott.ssa Marina Chiara Garassino         
Roma_Campus Bio-Medico
Rome, Italy
Contact: Prof. Daniele Santini         
Principal Investigator: Prof. Daniele Santini         
Roma_Gemelli
Rome, Italy
Contact: Prof. Carlo Antonio Mario Barone         
Principal Investigator: Prof. Carlo Antonio Mario Barone         
Roma_Regina Apostolorum
Rome, Italy
Contact: Dott. Francesco Angelini         
Principal Investigator: Dott. Francesco Angelini         
Roma_Tor Vergata
Rome, Italy
Contact: Prof. Mario Roselli         
Principal Investigator: Prof. Mario Roselli         
Sant'Andrea Hospital
Rome, Italy
Contact: Prof. Paolo Marchetti         
Principal Investigator: Prof. Paolo Marchetti         
Presidio Sanitario San Camillo
Torino, Italy
Contact: Dott.ssa Maria Rita Migliorino         
Principal Investigator: Dott.ssa Maria Rita Migliorino         
Sponsors and Collaborators
SciClone Pharmaceuticals
Layout table for additonal information
Responsible Party: SciClone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02906150    
Other Study ID Numbers: SCI-Ta1-NSCLC-CHEMO P2-001
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Keywords provided by SciClone Pharmaceuticals:
EGFR Wild Type
Thymosin Alpha 1
Non-Small Cell Lung Cancer
Thymalfasin
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Carboplatin
Pemetrexed
Thymalfasin
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs