Trial Outcomes & Findings for Atezolizumab and Bevacizumab in EGFR Mutant NSCLC in Patients With Progressive Disease After Receiving Osimertinib (NCT NCT04099836)
NCT ID: NCT04099836
Last Updated: 2023-12-26
Results Overview
Objective response (complete or partial response) rate (ORR) is assessed by the investigator using Response Evaluation Criteria in Solid Tumors RECIST 1.1 (brand name) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
Atezolizumab and Bevacizumab
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atezolizumab and Bevacizumab in EGFR Mutant NSCLC in Patients With Progressive Disease After Receiving Osimertinib
Baseline characteristics by cohort
| Measure |
Atezolizumab and Bevacizumab
n=7 Participants
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
PS=0
|
7 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
PS=1
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
PS=2
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
PS=3
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
PS=4
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
PS=5
|
0 Participants
n=5 Participants
|
|
EGFR mutation
Exon 19
|
3 Participants
n=5 Participants
|
|
EGFR mutation
21 L858R
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsObjective response (complete or partial response) rate (ORR) is assessed by the investigator using Response Evaluation Criteria in Solid Tumors RECIST 1.1 (brand name) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab
n=7 Participants
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Objective Response Assessed by the Investigator Using RECIST 1.1
Non-response (stable disease or progression)
|
7 Participants
|
|
Objective Response Assessed by the Investigator Using RECIST 1.1
Overall response (OR) = CR + PR
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsProgression will be defined as time from start of study therapy to disease progression or death whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median survival time and its 95% CI will be calculated.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab
n=7 Participants
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Progression Free Survival as Measured by RECIST v1.1 RECIST 1.1 (Brand Name) as Assessed by the Investigator.
|
2.1 months
Interval 0.5 to
The upper level of the 95% CI was not estimable at the time of analysis
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall survival (OS) is defined as the time from start of study therapy to death from any cause, and patients who are alive at the time of analysis will be censored at the last date of contact.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab
n=7 Participants
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Overall Survival as Noted by Follow-up Via Composite of Telephone or Medical Record Review.
|
6.4 Months
Interval 3.2 to
The upper level of the 95% CI was not estimable at the time of analysis
|
SECONDARY outcome
Timeframe: Up to 2 yearsAll patients who receive at least one dose of study treatment will be included in the safety analysis. The frequencies and percentage of treatment-related adverse events will be tabulated.
Outcome measures
| Measure |
Atezolizumab and Bevacizumab
n=7 Participants
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Number of Participants With AEs as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
|
7 Participants
|
Adverse Events
Atezolizumab and Bevacizumab
Serious events: 2 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Atezolizumab and Bevacizumab
n=7 participants at risk
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
General disorders
Figure
|
14.3%
1/7 • 2 years
|
|
Cardiac disorders
heart failure
|
14.3%
1/7 • 2 years
|
Other adverse events
| Measure |
Atezolizumab and Bevacizumab
n=7 participants at risk
Atezolizumab 1200 mg IV every 3 weeks and bevacizumab 15 mg/kg IV every 3 weeks (1 cycle=3 weeks)
Atezolizumab: 1200 mg IV
Bevacizumab: 15 mg/kg IV
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • 2 years
|
|
Investigations
Weight loss
|
28.6%
2/7 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • 2 years
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
28.6%
2/7 • 2 years
|
|
Eye disorders
Blurred vision
|
28.6%
2/7 • 2 years
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • 2 years
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • 2 years
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - intermittent ear fullness
|
14.3%
1/7 • 2 years
|
|
Eye disorders
Eye disorder - loss peripheral vision bilaterally
|
14.3%
1/7 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • 2 years
|
|
General disorders
Fatigue
|
57.1%
4/7 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Intermittent early satiety
|
14.3%
1/7 • 2 years
|
|
General disorders
Gait disturbance
|
28.6%
2/7 • 2 years
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
1/7 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • 2 years
|
|
Vascular disorders
Hypertension
|
42.9%
3/7 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • 2 years
|
|
Nervous system disorders
Memory impairment
|
28.6%
2/7 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
1/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
14.3%
1/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Intermittent loss in balance
|
14.3%
1/7 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.6%
2/7 • 2 years
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
14.3%
1/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • 2 years
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
1/7 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
28.6%
2/7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
1/7 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Pleurex right chest wall
|
14.3%
1/7 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
1/7 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place