Trial Outcomes & Findings for A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer (NCT NCT00983307)
NCT ID: NCT00983307
Last Updated: 2025-04-30
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
2 years
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Erlotinib and Radiotherapy
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib and Radiotherapy
n=17 Participants
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Erlotinib and Radiotherapy
n=17 Participants
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants That Experience Progression-free Survival.
|
1 Participants
|
Adverse Events
Erlotinib and Radiotherapy
Serious events: 15 serious events
Other events: 17 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Erlotinib and Radiotherapy
n=17 participants at risk
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Death
|
52.9%
9/17 • Number of events 9 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
General disorders
Headache
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Severe pain (back)
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea w/ADL
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Sodium, serum-low
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
General disorders
Fatigue
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Renal failure
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Elevated Glucose
|
5.9%
1/17 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Erlotinib and Radiotherapy
n=17 participants at risk
Patients will be treated with Erlotinib and hypofractionated radiotherapy.
Erlotinib: Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.
Hypofractionated Radiotherapy: Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Alkaline Phosphatase
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Anorexia
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Bilirubin Increased
|
35.3%
6/17 • Number of events 6 • 2 years
|
|
Eye disorders
Blepharitis
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Creatinine increased
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
General disorders
Decreased hearing in left ear
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.2%
7/17 • Number of events 7 • 2 years
|
|
General disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
General disorders
Dysgeusia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
General disorders
Edema
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
dysmorphic nail bed
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
41.2%
7/17 • Number of events 7 • 2 years
|
|
Immune system disorders
Fever
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Glucose, serum-high
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
General disorders
Headache
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Cardiac disorders
Elevated Heart Rate
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Elevated Hemoglobin
|
23.5%
4/17 • Number of events 4 • 2 years
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Hyponatremia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Vaginal Infection
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Magnesium
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
General disorders
Nausea
|
29.4%
5/17 • Number of events 5 • 2 years
|
|
General disorders
Pain
|
17.6%
3/17 • Number of events 3 • 2 years
|
|
Nervous system disorders
Peripheral neuropathy
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Platelets
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
70.6%
12/17 • Number of events 12 • 2 years
|
|
Nervous system disorders
Tremor
|
11.8%
2/17 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Vaginal dryness and irritation
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
White Blood Cells in Urine
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
General disorders
Weight loss
|
5.9%
1/17 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • 2 years
|
Additional Information
Dr. Maria Werner-Wasik
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215 955-6702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place