Trial Outcomes & Findings for A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer (NCT NCT03329911)
NCT ID: NCT03329911
Last Updated: 2021-09-14
Results Overview
The primary efficacy endpoint is ORR at Week 18 (ORR18) based on tumor response evaluated according to RECIST 1.1 as assessed by CIR. Each patient will be assigned to one of the following RECIST 1.1 categories based on independent CIR, irrespective of protocol deviations or missing data: CR: complete response. PR: partial response. SD: stable disease. PD: progressive disease. NE: not evaluable (insufficient data)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
651 participants
Primary outcome timeframe
Week 18
Results posted on
2021-09-14
Participant Flow
Participant milestones
| Measure |
EU Avastin®
Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
EU Avastin®: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
BAT1706
BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
BAT1706: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
|---|---|---|
|
Overall Study
STARTED
|
326
|
325
|
|
Overall Study
COMPLETED
|
209
|
222
|
|
Overall Study
NOT COMPLETED
|
117
|
103
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
EU Avastin®
n=326 Participants
Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
EU Avastin®: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
BAT1706
n=325 Participants
BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
BAT1706: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
Total
n=651 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
208 Participants
n=93 Participants
|
233 Participants
n=4 Participants
|
441 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
118 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
210 Participants
n=27 Participants
|
|
Age, Continuous
|
60 years
n=93 Participants
|
61 years
n=4 Participants
|
61 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
194 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=93 Participants
|
228 Participants
n=4 Participants
|
457 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
140 Participants
n=93 Participants
|
141 Participants
n=4 Participants
|
281 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=93 Participants
|
172 Participants
n=4 Participants
|
343 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
67 participants
n=93 Participants
|
64 participants
n=4 Participants
|
131 participants
n=27 Participants
|
|
Region of Enrollment
China
|
139 participants
n=93 Participants
|
140 participants
n=4 Participants
|
279 participants
n=27 Participants
|
|
Region of Enrollment
Ukraine
|
98 participants
n=93 Participants
|
102 participants
n=4 Participants
|
200 participants
n=27 Participants
|
|
Region of Enrollment
South Africa
|
6 participants
n=93 Participants
|
2 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
16 participants
n=93 Participants
|
17 participants
n=4 Participants
|
33 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 18The primary efficacy endpoint is ORR at Week 18 (ORR18) based on tumor response evaluated according to RECIST 1.1 as assessed by CIR. Each patient will be assigned to one of the following RECIST 1.1 categories based on independent CIR, irrespective of protocol deviations or missing data: CR: complete response. PR: partial response. SD: stable disease. PD: progressive disease. NE: not evaluable (insufficient data)
Outcome measures
| Measure |
EU Avastin®
n=326 Participants
Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
EU Avastin®: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
BAT1706
n=325 Participants
BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
BAT1706: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
|---|---|---|
|
Overall Response Rate
|
156 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: 8 months,1 year and 2 yearsProgression free survival rate at 12 months, defined as the proportion of patients being alive without documented progression 12 months after randomization, using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 months,1 year and 2 yearsProgression free survival time defined as the time from the date of randomization to the date of documented clinical or radiological progression or death due to any cause using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 months,1 year and 2 yearsOverall survival rate at 12 months, defined as the proportion of patients being alive 12 months after randomization using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 months,1 year and 2 yearsOverall survival time defined as the time from randomization to death of any cause using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6 and Week 12ORR at Week 6 (ORR6) and ORR at Week 12 (ORR12), based on tumor response as assessed by CIR, and best ORR of confirmed responses at end of study assessed by local radiologist/Investigator if after Week 18 according to RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsDuration of response defined as the time from first documentation of a response (CR or PR) and the first documentation of progression (assessed by local radiologist/Investigator if after Week 18) according to RECIST 1.1.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPlasma level of anti drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA) correlated with bevacizumab plasma level
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsBevacizumab plasma exposure following treatments of BAT1706 or EU Avastin®
Outcome measures
Outcome data not reported
Adverse Events
EU Avastin®
Serious events: 119 serious events
Other events: 8 other events
Deaths: 4 deaths
BAT1706
Serious events: 119 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
EU Avastin®
n=324 participants at risk
Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
EU Avastin®: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
BAT1706
n=325 participants at risk
BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
BAT1706: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
14.2%
46/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
9.5%
31/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Infections and infestations
Infections and infestations
|
6.8%
22/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
8.3%
27/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
5.9%
19/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
6.5%
21/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
General disorders
Gastrointestinal disorders
|
3.7%
12/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
3.7%
12/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Cardiac disorders
Cardiac disorders
|
1.2%
4/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
3.4%
11/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Vascular disorders
Vascular disorders
|
2.5%
8/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
1.5%
5/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Gastrointestinal disorders
General disorders and administration site conditions
|
1.2%
4/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
2.5%
8/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Nervous system disorders
Nervous system disorders
|
1.2%
4/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
1.2%
4/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
Other adverse events
| Measure |
EU Avastin®
n=324 participants at risk
Drug:EU Avastin® 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with Bevacizumab-EU up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
EU Avastin®: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
BAT1706
n=325 participants at risk
BAT1706 15 mg/kg IV infusions ,every 3 weeks of a cycle for up to 6 cycles, followed for those with non-progressive disease with maintenance monotherapy with BAT1706 up to a maximum of 8 months.
Drug: Paclitaxel 200mg/m² via IV infusions, every 3 weeks of a cycle for up to 6 cycles
Drug: Carboplatin AUC 6.0 mg/mL•minute via IV infusions,every 3 weeks of a cycle for up to 6 cycles
BAT1706: 100 mg/4 mL
Paclitaxel: 200 mg/m²
carboplatin: target area under the curve \[AUC\] 6 mg/mL•minute
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (inclcysts and polyps)
|
0.62%
2/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
0.00%
0/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Hepatobiliary disorders
Hepatobiliarydisorders
|
0.31%
1/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
0.31%
1/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.62%
2/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
0.92%
3/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.93%
3/324 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
1.5%
5/325 • From the start of the first study medication administration until 28 days after discontinuation/completion of the study medication or up to Week 53 after randomization- All AEs, regardless of relationship to the study medication/study procedures. During the LTE study, only adverse events of special interest (AESIs) and SAEs until 28 days after the subject's last dose will be collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place