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
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 be 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
Clareo Health | 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
