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

Phase 1

• Conditions: The intended use of SB8 is the treatment of metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); MedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000015833; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004026-34-HU
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-19
• Last Update Posted: 17 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 678

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.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified