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

Phase 2

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Thymalfasin (Thymosin alpha 1, Ta1); Drug: SoC (chemotherapy and platinum agent)

• Registration Number: NCT02906150
• Lead Sponsor: SciClone Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-16
• Last Update Submitted: 2016-09-16
• Study First Posted: 2016-09-19
• Last Update Posted: 2016-09-19
• Primary Completion: 2019-05
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thymalfasin (Thymosin alpha 1, Ta1)	Thymalfasin (Thymosin alpha 1, Ta1)	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.
Thymalfasin (Thymosin alpha 1, Ta1)	SoC (chemotherapy and platinum agent)	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.
SoC (chemotherapy and platinum agent)	SoC (chemotherapy and platinum agent)	Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months.

Primary Outcome Measures

Name	Time	Method
Time to progression free survival (PFS)	Up to 12 months

Trial Locations

Locations (8)

Roma_Gemelli; 🇮🇹 Rome, Italy

Roma_Tor Vergata; 🇮🇹 Rome, Italy

Sant'Andrea Hospital; 🇮🇹 Rome, Italy

Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy

Roma_Campus Bio-Medico; 🇮🇹 Rome, Italy

Azienda Sanitaria Locale Frosinone; 🇮🇹 Frosinone, Italy

Presidio Sanitario San Camillo; 🇮🇹 Torino, Italy

Roma_Regina Apostolorum; 🇮🇹 Rome, Italy