First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy

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 coming back (at least) to grade 1
• •Pregnancy or suspected pregnancy
• •Known severe hypersensitivity to TKI
• •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