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

Study Overview
=================
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

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

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Thymalfasin (Thymosin alpha 1, Ta1)
* Drug: SoC (chemotherapy and platinum agent)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymalfasin (Thymosin alpha 1, Ta1)<br>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)<br>* 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.<br>* Other names: ZADAXIN;Drug: SoC (chemotherapy and platinum agent)<br>* 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.<br>* Other names: Pemetrexed, carboplatin or cisplatin;|
| Active Comparator: SoC (chemotherapy and platinum agent)<br>Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months. | Drug: SoC (chemotherapy and platinum agent)<br>* 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.<br>* Other names: Pemetrexed, carboplatin or cisplatin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression free survival (PFS) |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR Wild Type, Thymosin Alpha 1, Non-Small Cell Lung Cancer, Thymalfasin