At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 651 enrolled
Drug / intervention
EU Avastin® +3 moredrug
Likely dose
Paclitaxel 200 mg/m² and carboplatin AUC 6 mg/mL•minute with BAT1706 or EU Avastin® 100 mg/4 mLAI-extracted
Key inclusion· 5
- ✓Stage IV non-squamous NSCLC or recurrent disease not amenable to curative surgery/local therapy (histologically or cytologically confirmed)
- ✓No prior systemic therapy for metastatic disease; prior therapy for locally advanced disease allowed if completed ≥6 months before randomization
- ✓Tumors without activating EGFR or ALK mutation (or unknown status, or known mutations if targeted agent unavailable)
- ✓At least one measurable target lesion per RECIST 1.1; bone-only and brain-only metastases not allowed
Key exclusion· 6
- ✕Small cell carcinoma, squamous cell carcinoma, or NSCLC not otherwise specified
- ✕Tumor cavitation, tumor invading large blood vessels, or close proximity to large vessels with increased bleeding risk
- ✕Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGFR, including Avastin®
- ✕Prior systemic therapy for metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating EU Avastin®, BAT1706, and 2 other interventions for Non-squamous Non-small Cell Lung Cancer. Completed, enrolled 651 participants across 5 sites in 5 countries.
Detailed 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®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-squamous Non-small Cell Lung Cancer
CountriesChina, Mexico, South Africa, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedNov 2017
Primary CompletionNov 2019
Study CompletionMay 2021
TodayJul 2026
First PostedNov 6, 2017
Enrollment StartOct 20, 2017
Primary CompletionNov 5, 2019
Study CompletionMay 27, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.7 years ago
Interventions
EU Avastin®drug
100 mg/4 mL
BAT1706drug
100 mg/4 mL
Paclitaxeldrug
200 mg/m²
carboplatindrug
target area under the curve \[AUC\] 6 mg/mL•minute