Status:
COMPLETED
A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer
Lead Sponsor:
Bio-Thera Solutions
Conditions:
Non-squamous Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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® ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2021
Estimated Enrollment :
651 Patients enrolled
Trial Details
Trial ID
NCT03329911
Start Date
October 20 2017
End Date
May 27 2021
Last Update
September 14 2021
Active Locations (5)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, China
2
Clinical Medical Research S.C.
Orizaba, Mexico, 94300
3
National Hospital Oncology
Bloemfontein, South Africa, 9301
4
Baskent University Ankara Hospital
Ankara, Turkey (Türkiye), 6000