A Phase 3 interventional study of Bevacizumab and SB8 in Lung Cancer and Non-small Cell Lung Cancer, sponsored by Samsung Bioepis Co., Ltd.. Completed at 105 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Samsung Bioepis Co., Ltd. · Phase 3, Interventional, and Treatment
This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, 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 SB8 and bevacizumab.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 763 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Avastin® + Carboplatin/Paclitaxel
Drug: Bevacizumab · Drug: Carboplatin · Drug: Paclitaxel
SB8 + Carboplatin/Paclitaxel
Drug: SB8 · Drug: Carboplatin · Drug: Paclitaxel
Avastin® 15 mg/kg IV every 3 weeks on Day 1
Also known as: Avastin®
SB8 15 mg/kg IV every 3 weeks on Day 1
Also known as: SB8 (A proposed bevacizumab biosimilar)
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Also known as: Taxol
Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks
The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: 24 weeks from randomisation
Progression Free Survival
PFS is defined as the time from the date of Randomisation to the date of disease progression (progressive disease \[PD\]) or death regardless of the cause of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
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
Overall Survival
OS was defined as the time from the date of randomisation to the date of death regardless of the cause of death. Subjects who were alive at the time of analysis were censored at the date of last known alive.
Time frame: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Duration of Response (DoR)
DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Time frame: from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE
Time frame: AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation.
Pharmacokinetics: Trough Level [Ctrough]
Ctrough at selected cycles (i.e., Cycle 1, 3, 5 and 7)
Time frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Pharmacokinetics: Maximum Plasma Concentration [Cmax]
Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7)
Time frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Immunogenicity Assessments (Anti-drug Antibodies)
Incidence of anti-drug (bevacizumab) antibodies (ADA) The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below: * 'Positive' for a subject with treatment-induced or treatment-boosted ADA, where treatment-induced ADA indicated at least one positive result after pre-dose of Cycle 1 for subjects with negative ADA at pre-dose of Cycle 1, and treatment-boosted ADA indicated at least one positive result with higher titre level compared to pre-dose of Cycle 1 after pre-dose of Cycle 1 for subjects with positive ADA at pre-dose of Cycle 1. * 'Negative' for a subject without positive ADA until Cycle 7 and EOT. * 'Inconclusive' for a subject with positive ADA at Cycle 1 and without positive result with higher titre level observed after pre-dose of Cycle 1 up to Cycle 7 and EOT.
Time frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.
Immunogenicity Assessments (Neutralizing Antibodies)
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF. The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary. Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies).
Time frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.
Best Objective Response Rate by 11 and 17 Weeks
Best Objective Response Rate (ORR) by 11 weeks and 17 weeks
Time frame: 11 weeks and 17 weeks from randomisation
| Milestone | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) |
|---|---|---|
| Started | 384 | 379 |
| Completed | 38 | 35 |
| Not completed | 346 | 344 |
The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) |
|---|---|---|
| Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks | 42.8 | 47.6 |
PFS is defined as the time from the date of Randomisation to the date of disease progression (progressive disease \[PD\]) or death regardless of the cause of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
| months | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| FAS | 8.50 (7.40 to 9.70) | 7.90 (7.40 to 9.50) |
| PPS | 8.50 (7.20 to 9.70) | 7.90 (7.30 to 9.40) |
OS was defined as the time from the date of randomisation to the date of death regardless of the cause of death. Subjects who were alive at the time of analysis were censored at the date of last known alive.
| months | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| FAS | 14.90 (13.30 to 17.10) | 15.80 (13.60 to 17.10) |
| PPS | 14.80 (13.00 to 17.10) | 15.80 (13.80 to 17.70) |
DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
| months | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| FAS | 6.38 ± 3.773 | 6.79 ± 4.117 |
| PPS | 6.33 ± 3.784 | 6.81 ± 4.177 |
After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE
| Participants | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| TEAEs | 348 | 346 |
| CTCAE Grade 1 | 47 | 57 |
| CTCAE Grade 2 | 127 | 134 |
| CTCAE Grade 3 | 119 | 97 |
| CTCAE Grade 4 | 33 | 31 |
| CTCAE Grade 5 | 22 | 27 |
Ctrough at selected cycles (i.e., Cycle 1, 3, 5 and 7)
| ug/mL | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| Cycle 1 | 0.0000 ± 0.00000 | 0.0000 ± 0.00000 |
| Cycle 3 | 83.7568 ± 44.49701 | 102.3939 ± 69.36822 |
| Cycle 5 | 109.0906 ± 50.65915 | 119.9343 ± 54.65786 |
| Cycle 7 | 121.7382 ± 62.62150 | 133.7669 ± 58.84136 |
Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7)
| ug/mL | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| Cycle 1 | 306.0352 ± 98.71872 | 302.6362 ± 87.10467 |
| Cycle 3 | 374.9657 ± 106.54366 | 399.4598 ± 136.27431 |
| Cycle 5 | 389.3132 ± 123.07791 | 397.6183 ± 125.84175 |
| Cycle 7 | 397.5435 ± 120.74092 | 426.1350 ± 144.24538 |
Incidence of anti-drug (bevacizumab) antibodies (ADA) The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below: * 'Positive' for a subject with treatment-induced or treatment-boosted ADA, where treatment-induced ADA indicated at least one positive result after pre-dose of Cycle 1 for subjects with negative ADA at pre-dose of Cycle 1, and treatment-boosted ADA indicated at least one positive result with higher titre level compared to pre-dose of Cycle 1 after pre-dose of Cycle 1 for subjects with positive ADA at pre-dose of Cycle 1. * 'Negative' for a subject without positive ADA until Cycle 7 and EOT. * 'Inconclusive' for a subject with positive ADA at Cycle 1 and without positive result with higher titre level observed after pre-dose of Cycle 1 up to Cycle 7 and EOT.
| Participants | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| Cycle 1 (BL) — Positive | 15 | 15 |
| Cycle 1 (BL) — Negative | 357 | 356 |
| Cycle 1 (BL) — Inconclusive (only applicable for "Overall") | 0 | 0 |
| Cycle 3 — Positive | 29 | 22 |
| Cycle 3 — Negative | 309 | 316 |
| Cycle 3 — Inconclusive (only applicable for "Overall") | 0 | 0 |
| Cycle 5 — Positive | 15 | 21 |
| Cycle 5 — Negative | 286 | 275 |
| Cycle 5 — Inconclusive (only applicable for "Overall") | 0 | 0 |
| Cycle 7 — Positive | 28 | 20 |
| Cycle 7 — Negative | 238 | 259 |
| Cycle 7 — Inconclusive (only applicable for "Overall") | 0 | 0 |
| EOT — Positive | 21 | 9 |
| EOT — Negative | 129 | 152 |
| EOT — Inconclusive (only applicable for "Overall") | 0 | 0 |
| Cycle 7 Overall — Positive | 46 | 34 |
| Cycle 7 Overall — Negative | 284 | 294 |
| Cycle 7 Overall — Inconclusive (only applicable for "Overall") | 11 | 9 |
| EOT Overall — Positive | 55 | 37 |
| EOT Overall — Negative | 276 | 291 |
| EOT Overall — Inconclusive (only applicable for "Overall") | 10 | 9 |
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF. The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary. Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies).
| Participants | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| Cycle 1 (BL) — Positive | 0 | 1 |
| Cycle 1 (BL) — Negative | 15 | 14 |
| Cycle 3 — Positive | 9 | 9 |
| Cycle 3 — Negative | 20 | 13 |
| Cycle 5 — Positive | 5 | 8 |
| Cycle 5 — Negative | 10 | 13 |
| Cycle 7 — Positive | 12 | 11 |
| Cycle 7 — Negative | 16 | 9 |
| EOT — Positive | 9 | 5 |
| EOT — Negative | 12 | 4 |
Best Objective Response Rate (ORR) by 11 weeks and 17 weeks
| Participants | SB8 (A Proposed Bevacizumab Biosimilar) | Bevacizumab (Avastin) |
|---|---|---|
| 11 Weeks (FAS) | 107 | 100 |
| 11 Weeks (PPS) | 99 | 89 |
| 17 Weeks (FAS) | 159 | 152 |
| 17 Weeks (PPS) | 149 | 137 |
Collected over AEs were reported from the time the ICF was signed until the EOT visit, approximately 24 months from study initiation.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab (Avastin) | 171/380 (45%) | 81/380 (21.3%) | 316/380 (83.2%) |
| SB8 (A Proposed Bevacizumab Biosimilar) | 166/378 (43.9%) | 75/378 (19.8%) | 323/378 (85.4%) |
| Event | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) |
|---|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 9/380 | 4/378 |
| PneumoniaInfections and infestations | 0/380 | 7/378 |
| AnaemiaBlood and lymphatic system disorders | 4/380 | 6/378 |
| Febrile neutropeniaBlood and lymphatic system disorders | 6/380 | 2/378 |
| Sudden deathGeneral disorders | 6/380 | 4/378 |
| Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders | 5/380 | 3/378 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 3/380 | 3/378 |
| Shock haemorrhagicVascular disorders | 0/380 | 3/378 |
| NeutropeniaBlood and lymphatic system disorders | 3/380 | 0/378 |
| Haemorrhagic strokeNervous system disorders | 3/380 | 1/378 |
| Event | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) |
|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 183/380 | 184/378 |
| AnaemiaBlood and lymphatic system disorders | 87/380 | 87/378 |
| NauseaGastrointestinal disorders | 79/380 | 74/378 |
| NeutropeniaBlood and lymphatic system disorders | 69/380 | 74/378 |
| ThrombocytopeniaBlood and lymphatic system disorders | 45/380 | 57/378 |
| Neuropathy peripheralNervous system disorders | 54/380 | 38/378 |
| AstheniaGeneral disorders | 43/380 | 49/378 |
| FatigueGeneral disorders | 46/380 | 46/378 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 46/380 | 46/378 |
| HypertensionVascular disorders | 35/380 | 46/378 |
| Age, Categorical(Participants) | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 269 | 255 | 524 |
| >=65 years | 115 | 124 | 239 |
| Age, Continuous(years) | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) | Total |
|---|---|---|---|
| Mean | 60.0 ± 9.18 | 60.2 ± 8.95 | 60.1 ± 20.84 |
| Sex: Female, Male(Participants) | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) | Total |
|---|---|---|---|
| Female | 128 | 127 | 255 |
| Male | 256 | 252 | 508 |
| Race (NIH/OMB)(Participants) | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 35 | 32 | 67 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 348 | 347 | 695 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body Mass Index (BMI)(kg/m^2) | Bevacizumab (Avastin) | SB8 (A Proposed Bevacizumab Biosimilar) | Total |
|---|---|---|---|
| Mean | 25.49 ± 4.707 | 25.50 ± 4.809 | 25.50 ± 4.755 |
Showing the first 100 of 105 sites across 13 countries.
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Samsung Bioepis Co., Ltd.