Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, erlotinib, epidermal growth factor receptor, EGFR
Brief summary
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor. Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Detailed description
* Erlotinib is a pill taken daily and participants may continue to receive erlotinib for up to two years, as long as the cancer does not return and they do not experience any unacceptable side effects. * While participants are receiving erlotinib, they will be asked to return to the clinic for study visits to monitor the status of their disease and their general health. For the first 5 months of erlotinib, they will return to the clinic monthly. After that they will return to the clinic every three months.
Interventions
DRUGErlotinib
Oral drug taken daily around the same time. Starting dose is 150mg once daily.
Sponsors
Dana-Farber Cancer Institute
Genentech, Inc.
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology * Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria * Patients must have undergone surgical resection with curative intent within 6 months of enrollment * Sufficient tumor tissue available for EGFR mutation analysis * At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial). * 18 years of age or older * Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation * ECOG Performance status of 0,1, or 2 * Adequate organ function as outlined in protocol
Exclusion criteria
* Radiographic evidence of recurrent NSCLC prior to erlotinib treatment * Confirmed T790M resistance mutation in the primary tumor sample * Prior exposure to EGFR tyrosine kinase inhibitors * Known hypersensitivity to erlotinib, gefitinib, or any closely related drug * Pregnant or breastfeeding women * Any evidence of clinically active interstitial lung disease * Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study * Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Disease-free Survival | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treat Related Serious Adverse Events | From the start of treatment until 30 days after the end of treatment, up 13 months total | Adverse 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. |
| Median Overall Survival | From the time of registration until death, up to approximately 9 years | The median amount of time from the time of registration until death due to any cause |
| Median Disease Free Survival | From registration to disease recurrence or death, up to approximately 9 years | The median amount of time measured from the time of registration until the time of disease recurrence or death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Erlotinib: Oral drug taken daily around the same time. Starting dose is 150mg once daily. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Continuous | 63 years |
| EGFR Mutation Exon 19 Deletion | 62 Participants |
| EGFR Mutation G719X | 2 Participants |
| EGFR Mutation L858R | 35 Participants |
| EGFR Mutation L861Q | 1 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants |
| Race/Ethnicity, Customized Non-Asian | 83 Participants |
| Region of Enrollment United States | 100 Participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 23 Participants |
| Smoking Status <=10 pack years | 14 Participants |
| Smoking Status >10 pack years + current | 27 Participants |
| Smoking Status Never | 59 Participants |
| Stage Stage IA | 14 Participants |
| Stage Stage IB | 31 Participants |
| Stage Stage IIA | 11 Participants |
| Stage Stage IIB | 16 Participants |
| Stage Stage IIIA | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 99 / 100 |
| serious Total, serious adverse events | 20 / 100 |
Outcome results
Primary
2-year Disease-free Survival
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erlotinib | 2-year Disease-free Survival | 88 Participants |
Secondary
Median Disease Free Survival
The median amount of time measured from the time of registration until the time of disease recurrence or death.
Time frame: From registration to disease recurrence or death, up to approximately 9 years
Population: Median Disease Free Survival had not been met by the time of data cutoff.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Median Disease Free Survival | NA years |
Secondary
Median Overall Survival
The median amount of time from the time of registration until death due to any cause
Time frame: From the time of registration until death, up to approximately 9 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Median Overall Survival | NA years |
Secondary
Number of Participants With Treat Related Serious Adverse Events
Adverse 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.
Time frame: From the start of treatment until 30 days after the end of treatment, up 13 months total
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erlotinib | Number of Participants With Treat Related Serious Adverse Events | 20 Participants |