A study Comparing SB8 to Avastin in Subjects with Lung Cancer (Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer)

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2015-004026-34-DE
• Date of registration: 18/02/2016
• Prospective Registration: Yes
• Primary sponsor: Samsung Bioepis Co., Ltd.
• Public title: A study Comparing SB8 to Avastin in Subjects with Lung Cancer (Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer)
• Scientific title: A Phase III, Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB8 (proposed bevacizumab biosimilar) and Avastin® in Subjects with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
• Date of first enrolment: 27/06/2016
• Target sample size: 678
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004026-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belarus, Georgia, Germany, Hungary, Korea, Republic of, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Ukraine

Contacts

• Name: Hye Jung Na
• Affiliation: Samsung Bioepis Co., Ltd.

• Name: Hye Jung Na
• Affiliation: Samsung Bioepis Co., Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following criteria to be eligible for the study:
1. Aged = 18 years (if local regulations are different in this regard, follow the local regulations).
2. ECOG performance status of 0-1 at Screening.
3. Histologically and/or cytologically confirmed metastatic (AJCC 7th edition TNM stage IV) or recurrent non-squamous NSCLC or NSCLC-not otherwise specified (NOS).
4. At least one measurable lesion according to RECIST v1.1.

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 339
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 339

Exclusion criteria:
Subjects meeting any of the following criteria are not eligible for the study:
1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma of the lung. For mixed tumour with the component of squamous cell carcinoma, it should be categorised according to predominant histology. Any component of small cell carcinoma of the lung is to be excluded.
2. Known activating mutations in EGFR gene or transforming
rearrangements of ALK gene.
3. Radiological or clinical evidence of tumour invasion into blood vessels or close to large vessels that may have risk of bleeding at the discretion of Investigator.
4. History of systemic anti-cancer therapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
5. Any systemic anti-cancer therapy including neoadjuvant or adjuvant chemotherapy administered for NSCLC and completed less than 12 months prior to Randomisation.
6. Previously treated with a monoclonal antibody and/or molecule targeting VEGFR-related and/or EGFR-related signalling pathways.
7. Radiotherapy within 14 days prior to Randomisation (tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy are not considered as measurable lesion unless there has been demonstrated progression in the lesion).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The intended use of SB8 is the treatment of metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
MedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: SB8, proposed bevacizumab biosimilar
Product Code: SB8
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Current Sponsor code: SB8
Other descriptive name: SB8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: Avastin®
Product Name: Avastin®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): •The best ORR by 24 weeks of chemotherapy (best ORR is defined as the proportion of subjects whose best overall response is either complete response [CR] or partial response [PR] according to RECIST v1.1)

Timepoint(s) of evaluation of this end point: Tumour assessment will be performed after IP administration of Cycle 2, 4, and 6, and before planned Day 1 of Cycle 3, 5, and 7 and then will be performed every 4 cycles according to RECIST v1.1 and tumour size will be assessed by both Investigators and independent central reviewer.

Main Objective: To demonstrate the equivalence of SB8 to Avastin®, in terms of the best overall response rate (ORR) by 24 weeks of chemotherapy in subjects with metastatic or recurrent non squamous NSCLC.

Secondary Objective: • To evaluate the efficacy of SB8 compared to Avastin® by
- Progression free survival (PFS)
- Overall survival (OS)
- Duration of response (DOR)
• To evaluate the safety and tolerability of SB8 compared to Avastin®
• To evaluate the pharmacokinetics of SB8 compared to Avastin®
• To evaluate the immunogenicity of SB8 compared to Avastin®

Secondary Outcome(s)

Secondary end point(s): • Progression free survival (PFS)
• Overall survival (OS)
• Duration of response (DOR)

Timepoint(s) of evaluation of this end point: • Progression free survival (PFS), defined as the time from the date of Randomisation to the date of disease progression or death regardless of the cause of death. Subjects who are not progressed at the time of analysis will be censored at the date of EOT visit or the last tumour assessment date if the date of EOT is not available.
• Overall survival (OS), defined as the time from the date of Randomisation to the date of death regardless of the cause of death. Subjects who are alive at the time of analysis will be censored at the date of last known alive.
• Duration of response (DOR), defined as the time from documented tumour response (complete or partial) until documented disease progression. Only the subjects who achieve an initial tumour response will be evaluated for DOR.

Secondary ID(s)

SB8-G31-NSCLC

Source(s) of Monetary Support

Samsung Bioepis Co., Ltd.