Trial · NCT00567359

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

NCT00567359, Phase 2, Completed, Massachusetts General Hospital; results first posted 2018-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR. Trials, record NCT00567359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00567359

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
NCT number: NCT00567359
Status: Completed
Phases: Phase 2
Enrollment: 100 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Non-small Cell Lung Cancer
Interventions: Erlotinib
First posted: 2007-12-04
Last updated: 2018-12-11
Results first posted: 2018-12-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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
Secondary	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	2-year Disease-free Survival	2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Overall Survival	From the time of registration until death, up to approximately 9 years		years	MEDIAN
SECONDARY	Median Disease Free Survival	From registration to disease recurrence or death, up to approximately 9 years	Median Disease Free Survival had not been met by the time of data cutoff.	years	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
2-year Disease-free Survival	Erlotinib	88		Participants
Number of Participants With Treat Related Serious Adverse Events	Erlotinib	20		Participants
Median Overall Survival	Erlotinib	NA	95% Confidence Interval NA to NA	years
Median Disease Free Survival	Erlotinib	NA	95% Confidence Interval NA to NA	years

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Erlotinib	100
Overall Study	COMPLETED	Erlotinib	99
Overall Study	NOT COMPLETED	Erlotinib	1

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hemoglobin	Blood and lymphatic system disorders	Erlotinib	5	100	7
other	Leukocytes	Investigations	Erlotinib	5	100	5
other	Fatigue	General disorders	Erlotinib	63	100	92
other	Dry skin	Skin and subcutaneous tissue disorders	Erlotinib	49	100	68
other	Alopecia	Skin and subcutaneous tissue disorders	Erlotinib	19	100	19
other	Nail changes	Skin and subcutaneous tissue disorders	Erlotinib	27	100	40
other	Pruritus/itching	Skin and subcutaneous tissue disorders	Erlotinib	24	100	34
other	Rash/desquamation	Skin and subcutaneous tissue disorders	Erlotinib	22	100	38
other	Rash: acne/acneiform	Skin and subcutaneous tissue disorders	Erlotinib	74	100	163
other	Erythema multiforme	Skin and subcutaneous tissue disorders	Erlotinib	8	100	11

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Erlotinib	0	100
Total, other adverse events	Erlotinib	99	100
Total, serious adverse events	Erlotinib	20	100

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00567359

GET https://conductscience.org/api/trials/v1/NCT00567359/events?page=2

API reference For AI assistants