Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

• ClinicalTrials.gov Identifier: NCT01189435
• Recruitment Status: Terminated
• First Posted: August 26, 2010
• Results First Posted: April 21, 2015
• Last Update Posted: November 18, 2015
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Cancer
• Intervention: Drug: erlotinib
• Enrollment: 2

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Erlotinib
Arm/Group Description	This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy. erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Period Title: Overall Study
Started	2
Completed	0
Not Completed	2
Reason Not Completed
Withdrawal by Subject	1
Physician Decision	1

Baseline Characteristics

Arm/Group Title		Erlotinib
Arm/Group Description		This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy. erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Overall Number of Baseline Participants		2
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	0 0.0%
	>=65 years	2 100.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	Female	2 100.0%
	Male	0 0.0%

Outcome Measures

1. Primary Outcome

Title	To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib
Description	in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Erlotinib
Arm/Group Description:	This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy. erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Erlotinib
Arm/Group Description	This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy. erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
All-Cause Mortality
	Erlotinib
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Erlotinib
	Affected / at Risk (%)	# Events
Total	0/2 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Erlotinib
	Affected / at Risk (%)	# Events
Total	1/2 (50.00%)
Blood and lymphatic system disorders
Bilirubin (hyperbilirubinemia) † 1	1/2 (50.00%)	1
Metabolism and nutrition disorders
Glucose, high (hyperglycemia) † 1	1/2 (50.00%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTC-3.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Gregory Riely
• Organization: Memorial Sloan Kettering Cancer Center
• Phone: 646-888-4199
• EMail: rielyg@mskcc.org

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01189435
• Other Study ID Numbers: 10-097
• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Results First Submitted: April 7, 2015
• Results First Posted: April 21, 2015
• Last Update Posted: November 18, 2015