Trial Outcomes & Findings for Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer (NCT NCT00385996)

Last Updated: 2018-12-28

Results Overview

High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.

Results posted on

2018-12-28

Participant Flow

The recruitment period was from 10/13/06 to 10/8/08. Patients were recruited from the Weill Cornell Medical College Thoracic Surgery outpatient office.

Participant milestones

Participant milestones
Measure	Erlotinib Erlotinib 150 mg po daily.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=22 Participants Erlotinib 150 mg po daily
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.

Population: Population per protocol

Outcome measures

Outcome measures
Measure	Erlotinib n=22 Participants Erlotinib 150 mg po daily
Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.	1 Participants

SECONDARY outcome

Timeframe: From Day 1 until 30 days after the last study drug dose,

Population: Per protocol

Safety will be measured by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment. Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE.

Outcome measures

Outcome measures
Measure	Erlotinib n=22 Participants Erlotinib 150 mg po daily
Number of Participants With Grade 3, 4, or 5 Treatment Related Adverse Events as Assessed by CTCAE v3.0.	2 Participants

SECONDARY outcome

Timeframe: Every 3 months for the first 6 months, then yearly for 2 years.

Defined as the time from surgical resection to the time of recurrent disease in the primary or in metastatic sites.

Outcome measures

Outcome measures
Measure	Erlotinib n=22 Participants Erlotinib 150 mg po daily
Time-to-progression (TTP)	13.9 Months Interval 5.7 to 23.3

SECONDARY outcome

Timeframe: From date of erlotinib start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 25 months.

Defined as the time from the start of treatment to the time of recurrent disease in the primary or in metastatic sites.

Outcome measures

Outcome measures
Measure	Erlotinib n=22 Participants Erlotinib 150 mg po daily
Disease-free Survival (DFS)	22.7 Months Interval 6.9 to 24.5

Adverse Events

Erlotinib

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=22 participants at risk Erlotinib 150 mg po daily.
Vascular disorders Cerebral vascular accident	4.5% 1/22 • Number of events 1 • 26 months
Infections and infestations Wound infection	4.5% 1/22 • Number of events 1 • 26 months
Gastrointestinal disorders Diarrhea	4.5% 1/22 • Number of events 1 • 26 months
Respiratory, thoracic and mediastinal disorders Pulmonry embolus	4.5% 1/22 • Number of events 1 • 26 months

Other adverse events

Other adverse events
Measure	Erlotinib n=22 participants at risk Erlotinib 150 mg po daily.
General disorders Fatigue	27.3% 6/22 • Number of events 6 • 26 months
Skin and subcutaneous tissue disorders Rash	90.9% 20/22 • Number of events 20 • 26 months
Skin and subcutaneous tissue disorders Pruritis	13.6% 3/22 • Number of events 3 • 26 months
Gastrointestinal disorders Diarrhea	54.5% 12/22 • Number of events 12 • 26 months
Gastrointestinal disorders Nausea	27.3% 6/22 • Number of events 6 • 26 months
Gastrointestinal disorders Anorexia	18.2% 4/22 • Number of events 4 • 26 months
Skin and subcutaneous tissue disorders Epistaxis	13.6% 3/22 • Number of events 3 • 26 months
Gastrointestinal disorders Mucositis	22.7% 5/22 • Number of events 5 • 26 months
Eye disorders Dry eyes	13.6% 3/22 • Number of events 3 • 26 months
Gastrointestinal disorders Dry mouth	13.6% 3/22 • Number of events 3 • 26 months
Skin and subcutaneous tissue disorders Rhinitis	18.2% 4/22 • Number of events 4 • 26 months
Respiratory, thoracic and mediastinal disorders Cough	13.6% 3/22 • Number of events 3 • 26 months
Gastrointestinal disorders Dyspepsia/Heartburn	22.7% 5/22 • Number of events 5 • 26 months
Gastrointestinal disorders Sore throat	13.6% 3/22 • Number of events 3 • 26 months
Cardiac disorders Atrial fibrillation	22.7% 5/22 • Number of events 5 • 26 months

Additional Information

Nasser Altorki, MD

Weill Cornell Medical College

Phone: 212-746-5156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place