A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
- Conditions
- Non-small Cell Lung CancerLung Cancer
- Interventions
- Registration Number
- NCT03390686
- Lead Sponsor
- Prestige Biopharma Limited
- Brief Summary
In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.
- Detailed Description
This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 650
- Aged ≥ 18 years
- ECOG performance status of 0-1
- Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
- At least one measurable lesion according to RECIST v1.1.
- Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters
- Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
- Sensitizing EGFR mutations or ALK rearrangements
- Increased risk of bleeding determined by investigator based on radiographic / clinical findings
- History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HD204 (Bevacizumab biosimilar) HD204 HD204 + Carboplatin/Paclitaxel HD204 (Bevacizumab biosimilar) Carboplatin HD204 + Carboplatin/Paclitaxel Avastin (Bevacizumab) Carboplatin Avastin® + Carboplatin/Paclitaxel HD204 (Bevacizumab biosimilar) Paclitaxel HD204 + Carboplatin/Paclitaxel Avastin (Bevacizumab) Bevacizumab Avastin® + Carboplatin/Paclitaxel Avastin (Bevacizumab) Paclitaxel Avastin® + Carboplatin/Paclitaxel
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) at Week 18 18 weeks from randomization Percent patients within each treatment group who achieved complete response (CR) or partial response (PR) by the time of the Week 18 efficacy analysis in accordance with the RECIST 1.1. as assessed by CIR.
- Secondary Outcome Measures
Name Time Method ORR at Week 6 6 weeks from randomization Response at Week 6 will be evaluated by CIR to show the pattern of response
Incidence of Treatment-related Adverse Events using CTCAE v5.0 From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.
Change in tumour burden from baseline Up to 52 weeks from baseline Measured by the sum of longest diameters (SLD) of the target lesions
ORR at Week 12 12 weeks from randomization Response at Week 12 will be evaluated by CIR to show the pattern of response
ORR at Week 18 adjusted on dose intensity 18 weeks from randomization To compare ORR at Week 18 adjusted on dose intensity between treatment groups
Duration of Response from documented tumour response until disease progression up to 12 months from randomisation DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Anti-Drug Antibodies (Immunogenicity) Up to 52 weeks (at Baseline; end of Cycle 4 [pre-dose in cycle 5]; end of Cycle 7 [pre-dose in cycle 8]; and at EOT) Incidence of anti-drug (bevacizumab) antibodies (ADA)
Neutralizing Antibodies (Immunogenicity) Up to 52 weeks (at Baseline; end of Cycle 4 [predose in cycle 5]; end of Cycle 7 [predose in cycle 8]; and at EOT) Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)
Progression Free Survival From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation
Overall Survival (OS) From the date of randomisation to the date of death up to 12 months from randomisation OS defined as the time from Day 1 of therapy until death from any cause
Trough Level [Ctrough] (Pharmacokinetics) Up to 52 weeks (end of Cycle 1 [predose of Cycle 2], end of Cycle 3 [predose of Cycle 4], end of Cycle 5 [predose of Cycle 6] and EOT) Concentration observed 19 to 23 days after study drug administration
Maximum Plasma Concentration [Cmax] (Pharmacokinetics) Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.) Cmax at selected cycles
Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics) Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.) AUC0-t at selected cycles
Trial Locations
- Locations (18)
Tudogyogyintezet Torokbalint
🇭🇺Törökbálint, Hungary
Alexandrov Cancer Center
🇧🇾Minsk, Belarus
CHC Osijek
🇭🇷Osijek, Osijecko-baranjska, Croatia
MHAT "Dr. Tota Venkova", AD
🇧🇬Gabrovo, Bulgaria
Interbalkan Hospital
🇬🇷Thessaloníki, Asklipiou 10, Greece
LTD "High Technology Hospital Medcenter"
🇬🇪Batumi, Georgia
Institute of Clinical Oncology
🇬🇪Tbilisi, Georgia
HCG Manavata Cancer Centre
🇮🇳Nashik, Maharashtra, India
Riga East University Hospital Latvian Oncology centre
🇱🇻Riga, Latvia
Asian Hospital and Medical Center
🇵🇭Muntinlupa, Philippines
MEDSI
🇷🇺Moscow, Otradnoye, Russian Federation
Nemocnica na okraji mesta, n.o.
🇸🇰Partizánske, Slovakia
IPD of Vojvodina
🇷🇸Sremska Kamenica, Serbia
Maharaj Nakorn Chiang Mai
🇹🇭Chiang Mai, Muang, Thailand
Oncology Dispensary
🇺🇦Odessa, Ukraine
Acibadem Adana Hospital
🇹🇷Adana, Turkey
Magodend Szpital Elblaska
🇵🇱Warszawa, Poland
HRPZ II
🇲🇾Kota Bharu, Kelantan, Malaysia