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

NCT ID: NCT03329911

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 651 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2021-05-27

Brief 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®.

Conditions

Non-squamous Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EU Avastin®

Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.

Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles

Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles

Group Type: ACTIVE_COMPARATOR

EU Avastin®

Intervention Type: DRUG

100 mg/4 mL

Paclitaxel

Intervention Type: DRUG

200 mg/m²

carboplatin

Intervention Type: DRUG

target area under the curve \[AUC\] 6 mg/mL•minute

BAT1706

BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.

Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles

Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles

Group Type: EXPERIMENTAL

BAT1706

Intervention Type: DRUG

100 mg/4 mL

Paclitaxel

Intervention Type: DRUG

200 mg/m²

carboplatin

Intervention Type: DRUG

target area under the curve \[AUC\] 6 mg/mL•minute

Interventions

EU Avastin®

100 mg/4 mL

Intervention Type: DRUG

BAT1706

100 mg/4 mL

Intervention Type: DRUG

Paclitaxel

200 mg/m²

Intervention Type: DRUG

carboplatin

target area under the curve \[AUC\] 6 mg/mL•minute

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bio-Thera Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shengfeng Li

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, , China

Clinical Medical Research S.C.

Orizaba, , Mexico

National Hospital Oncology

Bloemfontein, , South Africa

Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

CI Kryvyi Rih Oncological Dispensary of DRC

Kryvyi Rih, , Ukraine

Countries

China; Mexico; South Africa; Turkey (Türkiye); Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BAT1706-003-CR

Identifier Type: -

Identifier Source: org_study_id