Trial Outcomes & Findings for TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00563784)
NCT ID: NCT00563784
Last Updated: 2019-11-20
Results Overview
Primary Endpoints is efficacy of concurrent erlotinib and chemoradiation as measured by time to progression. 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. All patients will be evaluated by followed up one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.
COMPLETED
PHASE2
68 participants
From date of registration until the date of first documented progression or death from any cause, or lost to follow up, whichever came first, assessed up to 5 years.
2019-11-20
Participant Flow
The recruitment period: Nov 20, 2007 to June 18,2010. Total 68 stage IIIA/IIIB Non-Small Cell Lung Cancer (NSCLC) patients registered in the study. Eligible criteria: stage III NSCLC, inoperable, Karnofsky score ≥ 80, weight loss ≤5% in 3 months, forced expiratory volume in 1 second ≥ 1.0 L, and adequate hematologic, hepatic, and renal function.
There were 20 patients off-study after enrollment due to screen failure. Two patients were taken off protocol: 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain. Only 46 patients are evaluable for this study.
Participant milestones
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Screen Failures
|
20
|
Baseline Characteristics
TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
n=48 Participants
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Arab Emirates
|
1 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Disease Stage IIIA
|
22 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Disease Stage IIIB
|
26 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Tumor Histology Adenocarcinoma
|
23 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Tumor Histology Squamous Cell Carcinoma
|
15 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Tumor Histology NSCLC Unspecified
|
9 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Karnofsky performance score (KPS) 100
|
3 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Karnofsky performance (KPS) score 90
|
32 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Karnofsky performance(KPS) score 80
|
13 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
EGFR status Wild-type
|
38 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
EGFR status- Mutated or deleted
|
4 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
EGFR status Unknown
|
6 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Smoking history Former
|
36 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Smoking history Current
|
6 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Smoking history Never
|
6 participants
n=5 Participants
|
|
Participants characteristic for completed treatment under the protocol and evaluable
Tumor HistologyLarge Cell Neuroendocrine Carcinoma
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of registration until the date of first documented progression or death from any cause, or lost to follow up, whichever came first, assessed up to 5 years.Population: There were 46 out of 48 patients completed treatment under the protocol and evaluable for data analysis. 2 patients cannot complete the treatment and off-study. 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain.
Primary Endpoints is efficacy of concurrent erlotinib and chemoradiation as measured by time to progression. 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. All patients will be evaluated by followed up one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.
Outcome measures
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
n=46 Participants
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Time To First Disease Progression
|
14 Month
Interval 9.0 to 18.6
|
SECONDARY outcome
Timeframe: OS: From date of registration until the date of first documented death or lost to follow up, whichever came first, accessed up to 5 years. DLC: From date of registration until the date of first documented local disease recurrence, accessed up to 5 years.Population: There were 46 out of 48 patients completed treatment under the protocol and evaluable for data analysis. 2 patients cannot complete the treatment and off-study. 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain.
The Secondary Endpoints is Overall Survival (OS)and Disease Local Control (DLC)Rate. All patients will be followed up to evaluate Overall Survival and Disease Local Control by one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years. CT scan of the chest/upper abdomen, MRI of brain or CT, and/or PET scan images are recommended to confirm the recurrence. Survival endpoints were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
n=46 Participants
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Overall Survival and Disease Local Control Rate
Local Regional Survival:5-year
|
55.8 percentage of participants
|
|
Overall Survival and Disease Local Control Rate
Overall Survival:5-year
|
35.9 percentage of participants
|
|
Overall Survival and Disease Local Control Rate
Disease Free Survival:5-year
|
25.8 percentage of participants
|
|
Overall Survival and Disease Local Control Rate
Distant Metastasis Free Survival:5-year
|
36.5 percentage of participants
|
Adverse Events
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
Serious adverse events
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
n=46 participants at risk
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
2.2%
1/46 • Number of events 1 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonititis
|
6.5%
3/46 • Number of events 3 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity, any
|
13.0%
6/46 • Number of events 6 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Acneform rash
|
4.3%
2/46 • Number of events 2 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
Other adverse events
| Measure |
Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA
n=46 participants at risk
TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
39.1%
18/46 • Number of events 18 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.2%
7/46 • Number of events 7 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity, any
|
21.7%
10/46 • Number of events 10 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Acneform rash
|
60.9%
28/46 • Number of events 28 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
|
General disorders
Fatigue
|
6.5%
3/46 • Number of events 3 • From the time of registration through study completion and follow up, assessed up to 5 years.
|
Additional Information
Dr. Steven H. Lin/Radiation Oncology
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place