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CompletedNCT00567359Updated Dec 11, 2018Results posted

Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

A Phase 2 interventional study of Erlotinib in Non-small Cell Lung Cancer, sponsored by Massachusetts General Hospital. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • NSCLC
  • erlotinib
  • epidermal growth factor receptor
  • EGFR
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Erlotinib

    Drug: Erlotinib

Interventions

  • DrugErlotinib

    Oral drug taken daily around the same time. Starting dose is 150mg once daily.

    Also known as: Tarceva

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Results

Posted Dec 11, 2018

Participant flow

Participant flow — Overall Study
MilestoneErlotinib
Started100
Completed99
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

Primary2-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
Reported as:
Count of participants · Participants
2-year Disease-free Survival
ParticipantsErlotinib
2-year Disease-free Survival88
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Treat Related Serious Adverse Events
ParticipantsErlotinib
Number of Participants With Treat Related Serious Adverse Events20
SecondaryMedian 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
Reported as:
Median · years
Median Overall Survival
yearsErlotinib
Median Overall SurvivalNA (NA to NA)
SecondaryMedian 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
Reported as:
Median · years
Median Disease Free Survival
yearsErlotinib
Median Disease Free SurvivalNA (NA to NA)

Adverse events

Collected over From the start of treatment until 30 days after the end of treatment, up to 13 months total. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Erlotinib0/100 (0%)20/100 (20%)99/100 (99%)
Most frequent serious events
Most frequent serious events
EventErlotinib
Rash: acne/acneiformSkin and subcutaneous tissue disorders13/100
Diarrhea w/o prior colostomyGastrointestinal disorders3/100
Rash/desquamationSkin and subcutaneous tissue disorders3/100
FatigueGeneral disorders2/100
Hepatic-otherHepatobiliary disorders1/100
Muco/stomatitis by exam- oral cavityGastrointestinal disorders1/100
Pruritus/itchingSkin and subcutaneous tissue disorders1/100
Skin-otherSkin and subcutaneous tissue disorders1/100
TearingEye disorders1/100
UrticariaSkin and subcutaneous tissue disorders1/100
Most frequent other events
Showing 10 of 40
Most frequent other events
EventErlotinib
Rash: acne/acneiformSkin and subcutaneous tissue disorders74/100
Diarrhea w/o prior colostomyGastrointestinal disorders74/100
FatigueGeneral disorders63/100
Dry skinSkin and subcutaneous tissue disorders49/100
CoughRespiratory, thoracic and mediastinal disorders42/100
NauseaGastrointestinal disorders31/100
DyspneaRespiratory, thoracic and mediastinal disorders31/100
Nail changesSkin and subcutaneous tissue disorders27/100
Skin-otherSkin and subcutaneous tissue disorders26/100
Pruritus/itchingSkin and subcutaneous tissue disorders24/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)Erlotinib
Median63 (41 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)Erlotinib
Female77
Male23
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Erlotinib
Non-Asian83
Asian17
Region of Enrollment
Region of Enrollment(Participants)Erlotinib
United States100
Smoking Status
Smoking Status(Participants)Erlotinib
Never59
<=10 pack years14
>10 pack years + current27
Stage
Stage(Participants)Erlotinib
Stage IA14
Stage IB31
Stage IIA11
Stage IIB16
Stage IIIA28
EGFR Mutation
EGFR Mutation(Participants)Erlotinib
Exon 19 Deletion62
L858R35
G719X2
L861Q1
08

Study locations

8 sites
  • Stanford University
    Stanford, California 94305, United States
  • Massachusetts General Hosptial
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • North Shore Medical Center
    Peabody, Massachusetts 01960, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
  • Taussig Cancer Center
    Cleveland, Ohio 44195, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 1, 2009

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00567359
Lead sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Genentech, Inc.
Responsible party
Lecia V. Sequist (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Dec 4, 2007
Start date
Dec 2007
Primary completion
Dec 2017
Completion
Dec 2017
Results posted
Dec 11, 2018
Last update
Dec 11, 2018

Study contacts

Lecia V. Sequist, MD, MPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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