Clinical trial · Interventional
A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| HD204 | Drug | Bevacizumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HD204 (Bevacizumab biosimilar)
- description
- HD204 + Carboplatin/Paclitaxel
- interventionNames
- Drug: HD204
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Avastin (Bevacizumab)
- description
- Avastin® + Carboplatin/Paclitaxel
- interventionNames
- Drug: Bevacizumab
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Overall Response Rate (ORR) at Week 18
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 laboratory and clinical parameters Exclusion Criteria: * Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma * Sensitizing EGFR mutations or ALK rearrangements * Increased risk of bleeding determined by investigator based on radiographic / clinical findings * History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
References
Publications (0)
Data not yet available