Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03390686 | A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients | PHASE3 | ACTIVE NOT_RECRUITING | 650 | — | — | Nov 15, 2019 | Dec 1, 2025 | May 31, 2025 | 18 | Belarus, Bulgaria +15 |
Percent patients within each treatment group who achieved complete response (CR) or partial response (PR) by the time of the Week 18 efficacy analysis in accordance with the RECIST 1.1. as assessed by CIR.
| Arm | Type | Description |
|---|---|---|
| HD204 (Bevacizumab biosimilar) | EXPERIMENTAL | HD204 + Carboplatin/Paclitaxel |
| Avastin (Bevacizumab) | ACTIVE_COMPARATOR | Avastin® + Carboplatin/Paclitaxel |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | 15 mg/kg IV every 3 weeks on Day 1 |
| HD204 | DRUG | 15 mg/kg IV every 3 weeks on Day 1 |
| Carboplatin | DRUG | Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles |
| Paclitaxel | DRUG | Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
Inclusion Criteria: * Aged ≥ 18 years * ECOG performance status of 0-1 * Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer * At least one measurable lesion according to RECIST v1.1. * Able to receive bevacizumab, carboplatin and paclitaxel based on adequate la...