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

• ClinicalTrials.gov Identifier: NCT02906150
• Recruitment Status: Unknown
• First Posted: September 19, 2016
• Last Update Posted: September 19, 2016
• Sponsor: SciClone Pharmaceuticals
• Information provided by (Responsible Party): SciClone Pharmaceuticals

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Carlo Tomino, MD; carlotomino@gmail.com

Locations

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

More Information

• Responsible Party: SciClone Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02906150
• Other Study ID Numbers: SCI-Ta1-NSCLC-CHEMO P2-001
• First Posted: September 19, 2016
• 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:

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