Lung Cancer, Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBevacizumab
15 mg/kg IV every 3 weeks on Day 1
DRUGHD204
15 mg/kg IV every 3 weeks on Day 1
DRUGCarboplatin
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
DRUGPaclitaxel
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Sponsors
Prestige Biopharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) at Week 18 | 18 weeks from randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR at Week 12 | 12 weeks from randomization | Response at Week 12 will be evaluated by CIR to show the pattern of response |
| ORR at Week 18 adjusted on dose intensity | 18 weeks from randomization | To compare ORR at Week 18 adjusted on dose intensity between treatment groups |
| Duration of Response | from documented tumour response until disease progression up to 12 months from randomisation | DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject |
| Progression Free Survival | 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 |
| Overall Survival (OS) | From the date of randomisation to the date of death up to 12 months from randomisation | OS defined as the time from Day 1 of therapy until death from any cause |
| Change in tumour burden from baseline | Up to 52 weeks from baseline | Measured by the sum of longest diameters (SLD) of the target lesions |
| ORR at Week 6 | 6 weeks from randomization | Response at Week 6 will be evaluated by CIR to show the pattern of response |
| Anti-Drug Antibodies (Immunogenicity) | Up to 52 weeks (at Baseline; end of Cycle 4 [pre-dose in cycle 5]; end of Cycle 7 [pre-dose in cycle 8]; and at EOT) | Incidence of anti-drug (bevacizumab) antibodies (ADA) |
| Neutralizing Antibodies (Immunogenicity) | Up to 52 weeks (at Baseline; end of Cycle 4 [predose in cycle 5]; end of Cycle 7 [predose in cycle 8]; and at EOT) | Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) |
| Trough Level [Ctrough] (Pharmacokinetics) | Up to 52 weeks (end of Cycle 1 [predose of Cycle 2], end of Cycle 3 [predose of Cycle 4], end of Cycle 5 [predose of Cycle 6] and EOT) | Concentration observed 19 to 23 days after study drug administration |
| Maximum Plasma Concentration [Cmax] (Pharmacokinetics) | Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.) | Cmax at selected cycles |
| Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics) | Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.) | AUC0-t at selected cycles |
| Incidence of Treatment-related Adverse Events using CTCAE v5.0 | From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks | After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. |
Countries
Belarus, Bulgaria, Croatia, Georgia, Greece, Hungary, India, Latvia, Malaysia, Philippines, Poland, Russia, Serbia, Slovakia, Thailand, Turkey (Türkiye), Ukraine
Outcome results
None listed