Clinical trial NCT03390686: A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
Official title: A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Lead sponsor: Prestige Biopharma Limited
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Response Rate (ORR) at Week 18
timeFrame: 18 weeks from randomization
Secondary outcomes:
measure: ORR at Week 6
timeFrame: 6 weeks from randomization
measure: ORR at Week 12
timeFrame: 12 weeks from randomization
measure: ORR at Week 18 adjusted on dose intensity
timeFrame: 18 weeks from randomization
measure: Duration of Response
timeFrame: from documented tumour response until disease progression up to 12 months from randomisation
measure: Progression Free Survival
timeFrame: From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
measure: Overall Survival (OS)
timeFrame: From the date of randomisation to the date of death up to 12 months from randomisation
measure: Change in tumour burden from baseline
timeFrame: Up to 52 weeks from baseline
measure: Incidence of Treatment-related Adverse Events using CTCAE v5.0
timeFrame: From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks
measure: Anti-Drug Antibodies (Immunogenicity)
timeFrame: 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)
measure: Neutralizing Antibodies (Immunogenicity)
timeFrame: 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)
measure: Trough Level [Ctrough] (Pharmacokinetics)
timeFrame: 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)
measure: Maximum Plasma Concentration [Cmax] (Pharmacokinetics)
timeFrame: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
measure: Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics)
timeFrame: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Alexandrov Cancer Center
city: Gabrovo
country: Bulgaria
facility: MHAT "Dr. Tota Venkova", AD
city: Osijek
country: Croatia
facility: CHC Osijek
state: Osijecko-baranjska
city: Batumi
country: Georgia
facility: LTD "High Technology Hospital Medcenter"
city: Tbilisi
country: Georgia
facility: Institute of Clinical Oncology
city: Thessaloníki
country: Greece
facility: Interbalkan Hospital
state: Asklipiou 10
city: Törökbálint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Nashik
country: India
facility: HCG Manavata Cancer Centre
state: Maharashtra
city: Riga
country: Latvia
facility: Riga East University Hospital Latvian Oncology centre
city: Kota Bharu
country: Malaysia
facility: HRPZ II
state: Kelantan
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
city: Warszawa
country: Poland
facility: Magodend Szpital Elblaska
city: Moscow
country: Russian Federation
facility: MEDSI
state: Otradnoye
city: Sremska Kamenica
country: Serbia
facility: IPD of Vojvodina
city: Partizánske
country: Slovakia
facility: Nemocnica na okraji mesta, n.o.
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai
state: Muang
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Odessa
country: Ukraine
facility: Oncology Dispensary
Study officials:
References: