Trial Outcomes & Findings for A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations (NCT NCT03434418)
NCT ID: NCT03434418
Last Updated: 2023-10-17
Results Overview
The number of participants who have a partial response or complete response to the study drug. Complete response (CR) = Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm; partial response (PR) = ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2023-10-17
Participant Flow
Participant milestones
| Measure |
Osimertinib
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Osimertinib
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Overall Study
Disease Progression
|
11
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Decline in Performance Status (PS)
|
1
|
Baseline Characteristics
A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
Baseline characteristics by cohort
| Measure |
Osimertinib
n=17 Participants
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 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
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
|
ECOG performance status
ECOG = 0
|
7 Participants
n=5 Participants
|
|
ECOG performance status
ECOG = 1
|
10 Participants
n=5 Participants
|
|
EGFR mutation subtype
G719X
|
7 Participants
n=5 Participants
|
|
EGFR mutation subtype
L861Q
|
6 Participants
n=5 Participants
|
|
EGFR mutation subtype
G719X/L718X
|
1 Participants
n=5 Participants
|
|
EGFR mutation subtype
G719X/S768I
|
1 Participants
n=5 Participants
|
|
EGFR mutation subtype
L861Q/S768I
|
1 Participants
n=5 Participants
|
|
EGFR mutation subtype
G719X/V689L
|
1 Participants
n=5 Participants
|
|
Location of metastases
Bone
|
8 Participants
n=5 Participants
|
|
Location of metastases
Brain
|
5 Participants
n=5 Participants
|
|
Location of metastases
Liver
|
5 Participants
n=5 Participants
|
|
Location of metastases
Lung
|
4 Participants
n=5 Participants
|
|
Location of metastases
Lymph node
|
8 Participants
n=5 Participants
|
|
Location of metastases
Pleura
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsThe number of participants who have a partial response or complete response to the study drug. Complete response (CR) = Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm; partial response (PR) = ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline.
Outcome measures
| Measure |
Osimertinib
n=17 Participants
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsProgression will be defined as time from starting study therapy to disease progression or death (whichever occurs first).
Outcome measures
| Measure |
Osimertinib
n=17 Participants
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Progression Free Survival (PFS) as Measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
|
10.5 months
Interval 5.0 to 15.2
|
SECONDARY outcome
Timeframe: Up to 4 yearsAdverse events (regardless of attribution) observed in all enrolled participants, except for those withdrawn prior to study treatment or fail to receive study treatment for various reasons. Counts and percentages of participants who experienced any AEs are calculated.
Outcome measures
| Measure |
Osimertinib
n=17 Participants
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Diarrhea
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Fatigue
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Anorexia
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Weight loss
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Dyspnea
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Vomiting
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Abdominal pain
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Cough
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Acneiform rash
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Maculopapular Rash
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Respiratory failure
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Thromboembolic event
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsOverall survival as defined as time from starting study therapy until death from any causes.
Outcome measures
| Measure |
Osimertinib
n=17 Participants
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Overall Survival as Noted by Follow-up Via Composite of Telephone or Medical Record Review.
|
13.8 months
Interval 9.3 to 29.2
|
Adverse Events
Osimertinib
Serious events: 2 serious events
Other events: 17 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Osimertinib
n=17 participants at risk
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.9%
1/17 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Thromboembolic event
|
5.9%
1/17 • Up to 4 years
|
Other adverse events
| Measure |
Osimertinib
n=17 participants at risk
Osimertinib: 80 mg oral administration daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
76.5%
13/17 • Up to 4 years
|
|
General disorders
Fatigue
|
52.9%
9/17 • Up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
41.2%
7/17 • Up to 4 years
|
|
Metabolism and nutrition disorders
Weight loss
|
41.2%
7/17 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.3%
6/17 • Up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Up to 4 years
|
|
General disorders
Abdominal pain
|
29.4%
5/17 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
4/17 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
23.5%
4/17 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
23.5%
4/17 • Up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place