A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer

Non-squamous Non-small Cell Lung Cancer Clinical Trial

Official title:

A Multicenter, Randomized, Double Blind, Phase III Study of BAT1706 Versus EU Avastin® Plus Chemotherapy in Patients With Advanced Non Squamous Non Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329911
• Other study ID #: BAT1706-003-CR
• Status: Completed
• Phase: Phase 3
• Start date: October 20, 2017
• Est. completion date: May 27, 2021

Study information

• Verified date: September 2021
• Source: Bio-Thera Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706 to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: May 27, 2021
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Stage IV nsNSCLC or recurrent disease (any Stage at initial diagnosis) no longer amenable to curative surgery or local therapy (histologically or cytologically confirmed).

2. No prior systemic therapy for metastatic disease. Prior systemic therapy and/or radiotherapy for locally advanced disease is permitted if completed = 6 months prior to randomization.

3. Tumors without activating EGFR or ALK mutation. Patients with unknown mutation status or known activating EGFR or ALK mutation may be included provided the corresponding targeted agent is not available and chemotherapy is the standard of care of the study center.

4. At least one measurable target lesion according to RECIST 1.1 (Appendix 13.4) as confirmed by CIR; bone only and brain-only metastases are not allowed. Lesions previously treated with radiotherapy are non-target lesion.

5. Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy > 3 months based on Investigator's judgment.

Exclusion Criteria:

1. Diagnosis of small cell carcinoma of the lung, mixed predominant squamous cell carcinoma of the lung, NSCLC not otherwise specified.

2. Tumor cavitation, tumor invading into large blood vessels or close to large vessels with an increased risk of bleeding, according to Investigator's judgment.

3. Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGFR, including Avastin®.

4. Prior systemic therapy for metastatic disease.

5. Prior systemic anticancer therapy, or radiotherapy for locally advanced nsNSCLC if completed < 6 months prior to screening.

6. Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre invasive cancer of the cervix.

Related Conditions & MeSH terms

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

Intervention

Drug:
• EU Avastin®
100 mg/4 mL
• BAT1706
100 mg/4 mL
• Paclitaxel
200 mg/m²
• carboplatin
target area under the curve [AUC] 6 mg/mL•minute

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen
Mexico	Clinical Medical Research S.C.	Orizaba
South Africa	National Hospital Oncology	Bloemfontein
Turkey	Baskent University Ankara Hospital	Ankara
Ukraine	CI Kryvyi Rih Oncological Dispensary of DRC	Kryvyi Rih

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Thera Solutions

Countries where clinical trial is conducted

China,  Mexico,  South Africa,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Level of Anti Drug Antibodies (ADA) and Neutralizing Anti-drug Antibodies (NADA) Correlated With Bevacizumab Plasma Level	Plasma level of anti drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level	12 months
Other	Bevacizumab Plasma Exposure Following Treatments of BAT1706 or EU Avastin®	Bevacizumab plasma exposure following treatments of BAT1706 or EU Avastin®	12 months
Primary	Overall Response Rate	The primary efficacy endpoint is ORR at Week 18 (ORR18) based on tumor response evaluated according to RECIST 1.1 as assessed by CIR. Each patient will be assigned to one of the following RECIST 1.1 categories based on independent CIR, irrespective of protocol deviations or missing data: CR: complete response. PR: partial response. SD: stable disease. PD: progressive disease. NE: not evaluable (insufficient data)	Week 18
Secondary	Progression Free Survival Rate	Progression free survival rate at 12 months, defined as the proportion of patients being alive without documented progression 12 months after randomization, using Kaplan-Meier method.	8 months,1 year and 2 years
Secondary	Progression Free Survival Time	Progression free survival time defined as the time from the date of randomization to the date of documented clinical or radiological progression or death due to any cause using Kaplan-Meier method.	8 months,1 year and 2 years
Secondary	Overall Survival Rate	Overall survival rate at 12 months, defined as the proportion of patients being alive 12 months after randomization using Kaplan-Meier method.	8 months,1 year and 2 years
Secondary	Overall Survival Time	Overall survival time defined as the time from randomization to death of any cause using Kaplan-Meier method.	8 months,1 year and 2 years
Secondary	Overall Response Rate	ORR at Week 6 (ORR6) and ORR at Week 12 (ORR12), based on tumor response as assessed by CIR, and best ORR of confirmed responses at end of study assessed by local radiologist/Investigator if after Week 18 according to RECIST 1.1.	Week 6 and Week 12
Secondary	Duration of Response	Duration of response defined as the time from first documentation of a response (CR or PR) and the first documentation of progression (assessed by local radiologist/Investigator if after Week 18) according to RECIST 1.1.	8 months