Evaluation of FKB238 and Avastin® in patients with advanced/recurrent non-squamous non-small cell lung cancer
- Conditions
- Advanced/Recurrent Non Squamous Non-Small Cell Lung CancerMedDRA version: 19.0Level: HLTClassification code 10029664Term: Non-small cell neoplasms malignant of the respiratory tract cell type specifiedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004104-33-ES
- Lead Sponsor
- Centus Biotherapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 731
• Patients aged 18 years or older
• Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
• Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
• Existence of at least 1 measurable lesion by response evaluation criteria
• Adequate haematological, renal and liver function
Other inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130
• Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumours and mixed adenosquamous carcinomas of predominantly squamous nature
• Any unresolved toxicities from prior systemic therapy
• Known sensitising EGFR mutations or EML4-ALK translocation positive mutations
• Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
• Known hypersensitivity to any excipients of the IPs and combination chemotherapy
• Use of prohibited concomitant medication
• Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
• Fertile men or women of childbearing potential not using adequate contraception
Other exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy equivalence of FKB238 and EU-Avastin when used in combination with paclitaxel/carboplatin as measured by ORR;Secondary Objective: To compare FKB238 and EU-Avastin through:<br>- Progression-free Survival<br>- Overall Survival<br>- Duration Of Response<br>- Disease Control Rate<br>To compare the safety of FKB238 and EU-Avastin<br>To compare the ADAs produced by FKB238 and EU-Avastin<br>To compare the serum trough concentration (Ctrough) of FKB238 and EU-Avastin;Primary end point(s): Overall Response Rate (by Response Evaluation Criteria [RECIST] v1.1) assessed as the rate of the best response (complete response [CR] or partial response [PR]);Timepoint(s) of evaluation of this end point: From randomisation to study treatment discontinuation
- Secondary Outcome Measures
Name Time Method