Trial Outcomes & Findings for Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer (NCT NCT00976456)

NCT ID: NCT00976456

Last Updated: 2016-03-10

Results Overview

Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 271 participants
• Primary outcome timeframe: 42 months
• Results posted on: 2016-03-10

Participant Flow

Participant milestones

Measure	Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Overall Study STARTED	135	136
Overall Study COMPLETED	92	98
Overall Study NOT COMPLETED	43	38

Reasons for withdrawal

Measure	Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Overall Study Adverse Event	17	22
Overall Study Death	7	9
Overall Study Lack of Efficacy	5	2
Overall Study Withdrawal by Subject	3	1
Overall Study screening failure, unknown	11	4

Baseline Characteristics

Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Bevacizumab + Pemetrexed n=119 Participants Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin n=134 Participants Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks	Total n=253 Participants Total of all reporting groups
Age, Continuous	71.0 years n=5 Participants	72.0 years n=7 Participants	71.5 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	48 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	86 Participants n=7 Participants	160 Participants n=5 Participants

PRIMARY outcome

Timeframe: 42 months

Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).

Outcome measures

Measure	Bevacizumab + Pemetrexed n=119 Participants Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin n=134 Participants Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Progression Free Survival	4.8 months Interval 4.3 to 6.0	6.8 months Interval 5.8 to 7.4

SECONDARY outcome

Timeframe: 42 months

Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).

Outcome measures

Measure	Bevacizumab + Pemetrexed n=119 Participants Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin n=134 Participants Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Overall Survival	11.6 months Interval 8.6 to 14.4	14.4 months Interval 11.7 to 16.9

Adverse Events

Bevacizumab + Pemetrexed

Serious events: 8 serious events

Other events: 61 other events

Deaths: 0 deaths

Bevacizumab + Pemetrexed + Carboplatin

Serious events: 7 serious events

Other events: 97 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab + Pemetrexed n=119 participants at risk Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin n=134 participants at risk Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Respiratory, thoracic and mediastinal disorders dyspnea	6.7% 8/119 • Number of events 9	5.2% 7/134 • Number of events 7

Other adverse events

Measure	Bevacizumab + Pemetrexed n=119 participants at risk Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks	Bevacizumab + Pemetrexed + Carboplatin n=134 participants at risk Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Blood and lymphatic system disorders anaemia	51.3% 61/119 • Number of events 83	72.4% 97/134 • Number of events 146

Additional Information

Prof. Dr. Wolfgang Schuette

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Phone: +49 345 5591440

Email: wolfgang.schuette@martha-maria.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place