A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03390686
• Other study ID #: SAMSON-II
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 15, 2019
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: Prestige Biopharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 650
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Bevacizumab
15 mg/kg IV every 3 weeks on Day 1
• HD204
15 mg/kg IV every 3 weeks on Day 1
• Carboplatin
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
• Paclitaxel
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Locations

Country	Name	City	State
Belarus	Alexandrov Cancer Center	Minsk
Bulgaria	MHAT "Dr. Tota Venkova", AD	Gabrovo
Croatia	CHC Osijek	Osijek	Osijecko-baranjska
Georgia	LTD "High Technology Hospital Medcenter"	Batumi
Georgia	Institute of Clinical Oncology	Tbilisi
Greece	Interbalkan Hospital	Thessaloníki	Asklipiou 10
Hungary	Tudogyogyintezet Torokbalint	Törökbálint
India	HCG Manavata Cancer Centre	Nashik	Maharashtra
Latvia	Riga East University Hospital Latvian Oncology centre	Riga
Malaysia	HRPZ II	Kota Bharu	Kelantan
Philippines	Asian Hospital and Medical Center	Muntinlupa
Poland	Magodend Szpital Elblaska	Warszawa
Russian Federation	MEDSI	Moscow	Otradnoye
Serbia	IPD of Vojvodina	Sremska Kamenica
Slovakia	Nemocnica na okraji mesta, n.o.	Partizánske
Thailand	Maharaj Nakorn Chiang Mai	Chiang Mai	Muang
Turkey	Acibadem Adana Hospital	Adana
Ukraine	Oncology Dispensary	Odessa

Sponsors (1)

Lead Sponsor	Collaborator
Prestige Biopharma Limited

Countries where clinical trial is conducted

Belarus,  Bulgaria,  Croatia,  Georgia,  Greece,  Hungary,  India,  Latvia,  Malaysia,  Philippines,  Poland,  Russian Federation,  Serbia,  Slovakia,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) at Week 18	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.	18 weeks from randomization
Secondary	ORR at Week 6	Response at Week 6 will be evaluated by CIR to show the pattern of response	6 weeks from randomization
Secondary	ORR at Week 12	Response at Week 12 will be evaluated by CIR to show the pattern of response	12 weeks from randomization
Secondary	ORR at Week 18 adjusted on dose intensity	To compare ORR at Week 18 adjusted on dose intensity between treatment groups	18 weeks from randomization
Secondary	Duration of Response	DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject	from documented tumour response until disease progression up to 12 months from randomisation
Secondary	Progression Free Survival	PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation	From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Secondary	Overall Survival (OS)	OS defined as the time from Day 1 of therapy until death from any cause	From the date of randomisation to the date of death up to 12 months from randomisation
Secondary	Change in tumour burden from baseline	Measured by the sum of longest diameters (SLD) of the target lesions	Up to 52 weeks from baseline
Secondary	Incidence of Treatment-related Adverse Events using CTCAE v5.0	After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.	From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks
Secondary	Anti-Drug Antibodies (Immunogenicity)	Incidence of anti-drug (bevacizumab) antibodies (ADA)	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)
Secondary	Neutralizing Antibodies (Immunogenicity)	Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)	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)
Secondary	Trough Level [Ctrough] (Pharmacokinetics)	Concentration observed 19 to 23 days after study drug administration	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)
Secondary	Maximum Plasma Concentration [Cmax] (Pharmacokinetics)	Cmax at selected cycles	Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
Secondary	Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics)	AUC0-t at selected cycles	Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)