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

NCT03329911 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: BAT1706-003-CR
• Study Type: interventional
• Target: 651
• Locations: 5 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Progression Free Survival Rate

  8 months,1 year and 2 years

• Progression Free Survival Time

  8 months,1 year and 2 years

• Overall Survival Rate

  8 months,1 year and 2 years

• Overall Survival Time

  8 months,1 year and 2 years

• Overall Response Rate

  Week 6 and Week 12

Other Outcomes (2)

• Plasma Level of Anti Drug Antibodies (ADA) and Neutralizing Anti-drug Antibodies (NADA) Correlated With Bevacizumab Plasma Level

  12 months

• Bevacizumab Plasma Exposure Following Treatments of BAT1706 or EU Avastin®

  12 months

Study Arms (2)

EU Avastin®

ACTIVE COMPARATOR

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

Drug: EU Avastin®; Drug: Paclitaxel; Drug: carboplatin

BAT1706

EXPERIMENTAL

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

Drug: BAT1706; Drug: Paclitaxel; Drug: carboplatin

Interventions

EU Avastin® DRUG

100 mg/4 mL

EU Avastin®

BAT1706 DRUG

100 mg/4 mL

BAT1706

Paclitaxel DRUG

200 mg/m²

BAT1706; EU Avastin®

carboplatin DRUG

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

BAT1706; EU Avastin®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV nsNSCLC or recurrent disease (any Stage at initial diagnosis) no longer amenable to curative surgery or local therapy (histologically or cytologically confirmed).
• 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.
• 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.
• 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.
• Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy \> 3 months based on Investigator's judgment.

You may not qualify if:

• Diagnosis of small cell carcinoma of the lung, mixed predominant squamous cell carcinoma of the lung, NSCLC not otherwise specified.
• Tumor cavitation, tumor invading into large blood vessels or close to large vessels with an increased risk of bleeding, according to Investigator's judgment.
• Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGFR, including Avastin®.
• Prior systemic therapy for metastatic disease.
• Prior systemic anticancer therapy, or radiotherapy for locally advanced nsNSCLC if completed \< 6 months prior to screening.
• 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.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (5)

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

Clinical Medical Research S.C.

Orizaba, 94300, Mexico

Location

National Hospital Oncology

Bloemfontein, 9301, South Africa

Location

Baskent University Ankara Hospital

Ankara, 6000, Turkey (Türkiye)

Location

CI Kryvyi Rih Oncological Dispensary of DRC

Kryvyi Rih, 53213, Ukraine

Location

MeSH Terms

Interventions

Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Yufeng Zhang
• Organization: Bio-Thera Solutions Ltd.

yfzhang@bio-thera.com

+86 2038251386

Study Officials

• Shengfeng Li

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 6, 2017
• Study Start: October 20, 2017
• Primary Completion: November 5, 2019
• Study Completion: May 27, 2021
• Last Updated: September 14, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Locations

ZA (1); ME (1); CN (1); TU (1); UA (1)