Trial Outcomes & Findings for Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR (NCT NCT00567359)
NCT ID: NCT00567359
Last Updated: 2018-12-11
Results Overview
The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
2 years
Results posted on
2018-12-11
Participant Flow
Participant milestones
| Measure |
Erlotinib
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Erlotinib
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
Baseline characteristics by cohort
| Measure |
Erlotinib
n=100 Participants
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Asian
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=5 Participants
|
|
Smoking Status
Never
|
59 Participants
n=5 Participants
|
|
Smoking Status
<=10 pack years
|
14 Participants
n=5 Participants
|
|
Smoking Status
>10 pack years + current
|
27 Participants
n=5 Participants
|
|
Stage
Stage IA
|
14 Participants
n=5 Participants
|
|
Stage
Stage IB
|
31 Participants
n=5 Participants
|
|
Stage
Stage IIA
|
11 Participants
n=5 Participants
|
|
Stage
Stage IIB
|
16 Participants
n=5 Participants
|
|
Stage
Stage IIIA
|
28 Participants
n=5 Participants
|
|
EGFR Mutation
Exon 19 Deletion
|
62 Participants
n=5 Participants
|
|
EGFR Mutation
L858R
|
35 Participants
n=5 Participants
|
|
EGFR Mutation
G719X
|
2 Participants
n=5 Participants
|
|
EGFR Mutation
L861Q
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.
Outcome measures
| Measure |
Erlotinib
n=100 Participants
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
2-year Disease-free Survival
|
88 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment until 30 days after the end of treatment, up 13 months totalAdverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment.
Outcome measures
| Measure |
Erlotinib
n=100 Participants
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Number of Participants With Treat Related Serious Adverse Events
|
20 Participants
|
SECONDARY outcome
Timeframe: From the time of registration until death, up to approximately 9 yearsThe median amount of time from the time of registration until death due to any cause
Outcome measures
| Measure |
Erlotinib
n=100 Participants
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Median Overall Survival
|
NA years
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From registration to disease recurrence or death, up to approximately 9 yearsPopulation: Median Disease Free Survival had not been met by the time of data cutoff.
The median amount of time measured from the time of registration until the time of disease recurrence or death.
Outcome measures
| Measure |
Erlotinib
n=100 Participants
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Median Disease Free Survival
|
NA years
insufficient number of participants with events
|
Adverse Events
Erlotinib
Serious events: 20 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=100 participants at risk
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
3.0%
3/100 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
General disorders
Fatigue
|
2.0%
2/100 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Hepatobiliary disorders
Hepatic-other
|
1.0%
1/100 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
1.0%
1/100 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
1.0%
1/100 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
3.0%
3/100 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
13.0%
13/100 • Number of events 15 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
1.0%
1/100 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Eye disorders
Tearing
|
1.0%
1/100 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/100 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
Other adverse events
| Measure |
Erlotinib
n=100 participants at risk
Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
5/100 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Investigations
Leukocytes
|
5.0%
5/100 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
General disorders
Fatigue
|
63.0%
63/100 • Number of events 92 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
49.0%
49/100 • Number of events 68 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.0%
19/100 • Number of events 19 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
27.0%
27/100 • Number of events 40 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
24.0%
24/100 • Number of events 34 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
22.0%
22/100 • Number of events 38 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
74.0%
74/100 • Number of events 163 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.0%
8/100 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
26.0%
26/100 • Number of events 35 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
13/100 • Number of events 18 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
15/100 • Number of events 22 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
74.0%
74/100 • Number of events 120 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
5/100 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
10/100 • Number of events 14 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
20.0%
20/100 • Number of events 31 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Nausea
|
31.0%
31/100 • Number of events 44 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Taste disturbance
|
8.0%
8/100 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Vomiting
|
11.0%
11/100 • Number of events 13 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
GI-other
|
8.0%
8/100 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
13.0%
13/100 • Number of events 15 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Investigations
ALT, SGPT
|
7.0%
7/100 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Investigations
AST, SGOT
|
7.0%
7/100 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Investigations
Bilirubin
|
8.0%
8/100 • Number of events 20 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
13.0%
13/100 • Number of events 13 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Psychiatric disorders
Anxiety
|
8.0%
8/100 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Nervous system disorders
Neuropathy-sensory
|
17.0%
17/100 • Number of events 21 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Eye disorders
Dry eye syndrome
|
13.0%
13/100 • Number of events 16 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Eye disorders
Ocular-other
|
13.0%
13/100 • Number of events 19 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Gastrointestinal disorders
Abdomen, pain
|
7.0%
7/100 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
6.0%
6/100 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
5.0%
5/100 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Nervous system disorders
Head/headache
|
11.0%
11/100 • Number of events 14 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
5.0%
5/100 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
5.0%
5/100 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
General disorders
Pain-other
|
6.0%
6/100 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.0%
42/100 • Number of events 58 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.0%
31/100 • Number of events 48 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
13.0%
13/100 • Number of events 18 • From the start of treatment until 30 days after the end of treatment, up to 13 months total
Further descriptions are not available for adverse events listed as 'Other' under an organ system.
|
Additional Information
Lecia Van Dam Sequist, M.D.
Massachusetts General Hospital
Phone: 617-724-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place