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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02906150
• Other study ID #: SCI-Ta1-NSCLC-CHEMO P2-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 6, 2016
• Last updated: September 16, 2016
• Start date: September 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2016
• Source: SciClone Pharmaceuticals
• Contact: Carlo Tomino, MD
• Email: carlotomino[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Locale Frosinone	Frosinone
Italy	Istituto Nazionale dei Tumori	Milan
Italy	Roma_Campus Bio-Medico	Rome
Italy	Roma_Gemelli	Rome
Italy	Roma_Regina Apostolorum	Rome
Italy	Roma_Tor Vergata	Rome
Italy	Sant'Andrea Hospital	Rome
Italy	Presidio Sanitario San Camillo	Torino

Sponsors (1)

Lead Sponsor	Collaborator
SciClone Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression free survival (PFS)		Up to 12 months	Yes