Trial Outcomes & Findings for Atezolizumab Plus Bevacizumab in First Line NSCLC Patients (NCT NCT03836066)

NCT ID: NCT03836066

Last Updated: 2025-12-04

Results Overview

To evaluate the efficacy of Atezolizumab in combination with Bevacizumab as measured by Progression Free Survival according to Response Evaluation Criteria in Solid Tumours (RECIST).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
• Results posted on: 2025-12-04

Participant Flow

Participant milestones

Measure	Experimental: Atezolizumab plus Bevacizumab arm 1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
Overall Study STARTED	41
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atezolizumab Plus Bevacizumab in First Line NSCLC Patients

Baseline characteristics by cohort

Measure	Experimental: Atezolizumab Plus Bevacizumab Arm n=38 Participants 1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
Age, Continuous	64.5 years n=3 Participants
Sex: Female, Male Female	10 Participants n=3 Participants
Sex: Female, Male Male	28 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants
Race (NIH/OMB) White	38 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants
Smoking habit Non-smoker (≤ 100 cigarettes/lifetime)	2 Participants n=3 Participants
Smoking habit Former smoker (≥ 1 year without smoking)	21 Participants n=3 Participants
Smoking habit Smoker	15 Participants n=3 Participants
ECOG at diagnosis 0	16 Participants n=3 Participants
ECOG at diagnosis 1	22 Participants n=3 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Population: A total of 41 patients were enrolled in this study. However, at the time of diagnosis, only 38 patients were analyzed, as 3 patients were excluded from the outcome measure studies. For the safety analysis, all enrolled patients (41) were included.

To evaluate the efficacy of Atezolizumab in combination with Bevacizumab as measured by Progression Free Survival according to Response Evaluation Criteria in Solid Tumours (RECIST).

Outcome measures

Measure	Experimental: Atezolizumab plus Bevacizumab arm n=38 Participants 1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
Efficacy of Atezolizumab in Combination With Bevacizumab - PFS	11.3 Months Interval 8.1 to 16.5

Adverse Events

Experimental: Atezolizumab plus Bevacizumab arm

Serious events: 13 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental: Atezolizumab plus Bevacizumab arm n=41 participants at risk 1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
Gastrointestinal disorders Diarrhoea	2.4% 1/41 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Gastrointestinal disorders Gastrointestinal toxicity	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Hepatobiliary disorders Hepatitis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Infections and infestations Respiratory infection	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Renal and urinary disorders Nephrotic syndrome	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Renal and urinary disorders Nephritis	7.3% 3/41 • Number of events 3 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Cardiac disorders Myocardial infarction	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Gastrointestinal disorders Gastric perforation	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Infections and infestations Acute diverticulitis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Vascular disorders AAA - suspected contained rupture	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Vascular disorders Left leg thrombophlebitis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.

Other adverse events

Measure	Experimental: Atezolizumab plus Bevacizumab arm n=41 participants at risk 1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
General disorders Fatigue	4.9% 2/41 • Number of events 2 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Infections and infestations Acute diverticulitis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Investigations Alanine aminotransferase increased	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Renal and urinary disorders Proteinuria	7.3% 3/41 • Number of events 3 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Renal and urinary disorders Renal insufficiency	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Gastrointestinal disorders Diarrhoea	7.3% 3/41 • Number of events 3 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Gastrointestinal disorders Acute rectitis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
General disorders Edema limbs	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Infections and infestations Upper respiratory infection	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Investigations Serum amylase increased	4.9% 2/41 • Number of events 2 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Musculoskeletal and connective tissue disorders Arthritis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Renal and urinary disorders Nephritis	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Cardiac disorders Myocardial infarction	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Gastrointestinal disorders Anal fistula	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Gastrointestinal disorders Gastric perforation	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Vascular disorders Arterial thromboembolism	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Vascular disorders Hypertension	14.6% 6/41 • Number of events 6 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.
Vascular disorders AAA - suspected contained rupture	2.4% 1/41 • Number of events 1 • From the subject's written consent to participate in the study through 30 days after the final administration of the IMP, up to 5 years A total of 41 patients had received treatment and were included in the safety analysis.

Additional Information

Eva Pereira

Fundación GECP

Phone: +34 934302006

Email: gecp@gecp.org

Results disclosure agreements

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