Trial Outcomes & Findings for Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases (NCT NCT02971501)

Last Updated: 2026-04-28

Results Overview

The two study arms will be compared for PFS with Kaplan-Meier estimates and log-rank tests. The Rothman confidence interval (CI) will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease of the PFS data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence interval will be reported. Upon results entry, median PFS and range is provided due to study closure and early termination.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

From start of treatment to time of progression (in CNS or non-CNS disease) or death, whichever occurs first, assessed up to 63.7 months

Results posted on

2026-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Osimertinib, Bevacizumab) Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Bevacizumab: Given IV Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Osimertinib: Given PO	Arm II (Osimertinib) Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Osimertinib: Given PO
Overall Study STARTED	4	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Osimertinib, Bevacizumab) Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Bevacizumab: Given IV Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Osimertinib: Given PO	Arm II (Osimertinib) Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Osimertinib: Given PO
Overall Study Withdrawal by Subject	3	0
Overall Study Non Compliance	0	1
Overall Study Other	1	0

Baseline Characteristics

Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Osimertinib, Bevacizumab) n=4 Participants Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Bevacizumab: Given IV Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Osimertinib: Given PO	Arm II (Osimertinib) n=1 Participants Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Osimertinib: Given PO	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=9 Participants	1 Participants n=24 Participants	4 Participants n=23 Participants
Age, Categorical >=65 years	1 Participants n=9 Participants	0 Participants n=24 Participants	1 Participants n=23 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	1 Participants n=24 Participants	4 Participants n=23 Participants
Sex: Female, Male Male	1 Participants n=9 Participants	0 Participants n=24 Participants	1 Participants n=23 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	1 Participants n=24 Participants	2 Participants n=23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=9 Participants	0 Participants n=24 Participants	3 Participants n=23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Asian	1 Participants n=9 Participants	0 Participants n=24 Participants	1 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) White	2 Participants n=9 Participants	1 Participants n=24 Participants	3 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	0 Participants n=24 Participants	1 Participants n=23 Participants

PRIMARY outcome

Timeframe: From start of treatment to time of progression (in CNS or non-CNS disease) or death, whichever occurs first, assessed up to 63.7 months

Outcome measures

Outcome measures
Measure	Arm I (Osimertinib, Bevacizumab) n=4 Participants Patients receive osimertinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Bevacizumab: Given IV Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Osimertinib: Given PO	Arm II (Osimertinib) n=1 Participants Patients receive osimertinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Osimertinib: Given PO
Progression Free Survival (PFS)	15.2 months Interval 9.0 to 25.6	63.7 months Interval 63.7 to 63.7

SECONDARY outcome

Timeframe: From start of treatment to death, assessed up to 5.5 years

The two study arms will be compared for OS with Kaplan-Meier estimates and log-rank tests. The Rothman CI will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease of the OS data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence interval will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5.5 years

Assessed by Common Terminology Criteria for Adverse Events. Adverse medical events will be tabulated. National Cancer Institute toxicity grade 1 to grade 4 laboratory abnormalities will be listed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5.5 years

Will be estimated using the 95% confidence CI based on Wilson's method. The Wilcoxon rank sum test and Fisher's exact test will be applied to study the association between the response status and the continuous and categorical variables respectively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5.5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5.5 years

Will be assessed by Response Assessment in Neuro-Oncology Brain Metastases.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to time of progression in the CNS, assessed up to 5.5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5.5 years

Will be determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.