Clinical trial NCT03329911: A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-squamous Non-small Cell Lung Cancer
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 651
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.


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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: Week 18
Secondary outcomes:
measure: Progression Free Survival Rate
timeFrame: 8 months,1 year and 2 years
measure: Progression Free Survival Time
timeFrame: 8 months,1 year and 2 years
measure: Overall Survival Rate
timeFrame: 8 months,1 year and 2 years
measure: Overall Survival Time
timeFrame: 8 months,1 year and 2 years
measure: Overall Response Rate
timeFrame: Week 6 and Week 12
measure: Duration of Response
timeFrame: 8 months
Other outcomes:
measure: Plasma Level of Anti Drug Antibodies (ADA) and Neutralizing Anti-drug Antibodies (NADA) Correlated With Bevacizumab Plasma Level
timeFrame: 12 months
measure: Bevacizumab Plasma Exposure Following Treatments of BAT1706 or EU Avastin®
timeFrame: 12 months
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Orizaba
country: Mexico
facility: Clinical Medical Research S.C.
city: Bloemfontein
country: South Africa
facility: National Hospital Oncology
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Kryvyi Rih
country: Ukraine
facility: CI Kryvyi Rih Oncological Dispensary of DRC
Study officials:
affiliation: Sponsor GmbH
name: Shengfeng Li
role: STUDY_DIRECTOR
References: