A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
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ClinicalTrials.gov Identifier: NCT03390686 |
Recruitment Status :
Recruiting
First Posted : January 4, 2018
Last Update Posted : September 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer Non-small Cell Lung Cancer | Drug: Bevacizumab Drug: HD204 Drug: Carboplatin Drug: Paclitaxel | Phase 3 |
This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | November 15, 2019 |
Estimated Primary Completion Date : | May 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: HD204 (Bevacizumab biosimilar)
HD204 + Carboplatin/Paclitaxel
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Drug: HD204
15 mg/kg IV every 3 weeks on Day 1
Other Name: Bevacizumab Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Other Name: Taxol |
Active Comparator: Avastin (Bevacizumab)
Avastin® + Carboplatin/Paclitaxel
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Drug: Bevacizumab
15 mg/kg IV every 3 weeks on Day 1
Other Name: Avastin Drug: Carboplatin Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Drug: Paclitaxel Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Other Name: Taxol |
- Best Objective Response Rate by 24 weeks [ Time Frame: 24 weeks from randomization ]Any PR or CR prior to the 24th week will be marked as response
- Progression Free Survival [ Time Frame: From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject ]PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
- Overall Survival (OS) [ Time Frame: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject ]OS defined as the time from Day 1 of therapy until death from any cause
- Duration of Response [ Time Frame: from documented tumour response until disease progression up to 12 months from randomisation of the last subject ]DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
- Incidence of Treatment-related Adverse Events using CTCAE v4.03 [ Time Frame: AEs will be reported from the time the informed consent form (ICF) is signed until the EOT visit. The expected EOT visit for a final subject is approximately 30 months from study initiation. ]After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.
- Trough Level [Ctrough] (Pharmacokinetics) [ Time Frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) ]Ctrough at selected cycles
- Maximum Plasma Concentration [Cmax] (Pharmacokinetics) [ Time Frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) ]Cmax at selected cycles
- Anti-Drug Antibodies (Immunogenecity) [ Time Frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.) ]Incidence of anti-drug (bevacizumab) antibodies (ADA)
- Neutralizing Antibodies (Immunogenecity) [ Time Frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.) ]Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390686
Contact: Litha Jaison | +6569246535 | litha@pbpsg.com |

Study Chair: | Litha Jaison | Prestige Biopharma Limited |
Responsible Party: | Prestige Biopharma Limited |
ClinicalTrials.gov Identifier: | NCT03390686 |
Other Study ID Numbers: |
SAMSON-II |
First Posted: | January 4, 2018 Key Record Dates |
Last Update Posted: | September 8, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Bevacizumab Carboplatin |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |