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 | Unknown Phase 2 DMC

• 1 other identifier: SCI-Ta1-NSCLC-CHEMO P2-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 8

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

Conditions

Non-Small Cell Lung Cancer

Keywords

EGFR Wild Type; Thymosin Alpha 1; Non-Small Cell Lung Cancer; Thymalfasin

Outcome Measures

Primary Outcomes (1)

• Time to progression free survival (PFS)

  Up to 12 months

Study Arms (2)

Thymalfasin (Thymosin alpha 1, Ta1)

EXPERIMENTAL

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); Drug: SoC (chemotherapy and platinum agent)

SoC (chemotherapy and platinum agent)

ACTIVE COMPARATOR

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

Drug: SoC (chemotherapy and platinum agent)

Interventions

Thymalfasin (Thymosin alpha 1, Ta1) DRUG

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.

Also known as: ZADAXIN

Thymalfasin (Thymosin alpha 1, Ta1)

SoC (chemotherapy and platinum agent) DRUG

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.

Also known as: Pemetrexed, carboplatin or cisplatin

SoC (chemotherapy and platinum agent); Thymalfasin (Thymosin alpha 1, Ta1)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SciClone Pharmaceuticals: lead

Study Sites (8)

Azienda Sanitaria Locale Frosinone

Frosinone, Italy

Location

Istituto Nazionale dei Tumori

Milan, Italy

Location

Roma_Campus Bio-Medico

Rome, Italy

Location

Roma_Gemelli

Rome, Italy

Location

Roma_Regina Apostolorum

Rome, Italy

Location

Roma_Tor Vergata

Rome, Italy

Location

Sant'Andrea Hospital

Rome, Italy

Location

Presidio Sanitario San Camillo

Torino, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thymalfasin; Trace amine-associated receptor 1; Drug Therapy; Pemetrexed; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Carlo Tomino, MD

CONTACT

carlotomino@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

IT (8)