Trial Outcomes & Findings for Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR (NCT NCT00446225)
NCT ID: NCT00446225
Last Updated: 2025-03-05
Results Overview
The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
174 participants
Primary outcome timeframe
From the date of randomization to the date of last follow up, assessed up to 24 months
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
A: Erlotinib Group
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
87
|
|
Overall Study
COMPLETED
|
86
|
87
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
A: Erlotinib Group
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
Baseline characteristics by cohort
| Measure |
A: Erlotinib Group
n=86 Participants
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 Participants
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
France
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
54 participants
n=5 Participants
|
61 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Smoking status
Never smoked
|
57 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Smoking status
Previous smoker
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Smoking status
Current smoker
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 0
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 1
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 2
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status Scale
ECOG 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Histological diagnosis
Adenocarcinoma
|
82 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Histological diagnosis
Bronchoalveolar adenocarcinoma
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histological diagnosis
Large-cell carcinoma
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Histological diagnosis
Squamous-cell carcinoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histological diagnosis
Pleomorphic carcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histological diagnosis
Adenosquamous carcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histological diagnosis
Undifferentiated carcinomas
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Clinical stage
Stage IIIA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Clinical stage
Stage IIIB (malignant pleural effusion)
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Clinical stage
Stage IV
|
78 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Clinical stage
Stage II C
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Bone metastasis
Yes
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Bone metastasis
No
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Brain metastasis
Yes
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Brain metastasis
No
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Type of EGFR mutation
Deletion of exon 19
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Type of EGFR mutation
L858R mutation in exon 21
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Type of EGFR mutation
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of last follow up, assessed up to 24 monthsThe time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)
Outcome measures
| Measure |
A: Erlotinib Group
n=86 Participants
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 Participants
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Progression Free-survival
|
9.4 months
Interval 7.9 to 12.3
|
5.2 months
Interval 4.4 to 5.8
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of last follow up, assessed up to 24 monthsThe objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.
Outcome measures
| Measure |
A: Erlotinib Group
n=86 Participants
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 Participants
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Objective Response
Complete Response (CR)
|
2.3 percentage of participants
|
0 percentage of participants
|
|
Objective Response
Partial Response (PR)
|
62.8 percentage of participants
|
16.1 percentage of participants
|
|
Objective Response
Stable Disease (SD)
|
18.6 percentage of participants
|
49.4 percentage of participants
|
|
Objective Response
Progressive Disease (PD)
|
7 percentage of participants
|
12.6 percentage of participants
|
|
Objective Response
Missing (No Response Assessment)
|
9.3 percentage of participants
|
21.8 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of last follow up, assessed up to 24 monthsOverall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.
Outcome measures
| Measure |
A: Erlotinib Group
n=86 Participants
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 Participants
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Overall Survival
|
33.4 months
Interval 26.7 to 39.0
|
29.9 months
Interval 25.0 to 32.1
|
SECONDARY outcome
Timeframe: At baselinePopulation: Intention to treat. Serum sample taken at baseline
The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.
Outcome measures
| Measure |
A: Erlotinib Group
n=86 Sample of serum
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 Sample of serum
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Molecular Markers Related to EGFR and Study Pathology
Wild type
|
24 Sample of serum
|
23 Sample of serum
|
|
Molecular Markers Related to EGFR and Study Pathology
Not enough sample
|
32 Sample of serum
|
35 Sample of serum
|
|
Molecular Markers Related to EGFR and Study Pathology
Mutated
|
30 Sample of serum
|
29 Sample of serum
|
Adverse Events
A: Erlotinib Group
Serious events: 27 serious events
Other events: 70 other events
Deaths: 55 deaths
B: Standard Chemotherapy Group
Serious events: 25 serious events
Other events: 65 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
A: Erlotinib Group
n=86 participants at risk
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 participants at risk
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
3.4%
3/87 • Number of events 3 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Infections and infestations
Infection
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Infections and infestations
Sepsis
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Infections and infestations
Subcutaneous abscess
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
3/86 • Number of events 3 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
2.3%
2/87 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
2.3%
2/87 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
4.6%
4/87 • Number of events 4 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
3.4%
3/87 • Number of events 3 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
2.3%
2/87 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Nervous system disorders
Polyneuropathy
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Cardiac disorders
Cardiac tamponade
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Cardiac disorders
Pericarditis
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Vascular disorders
Thrombosis
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.3%
2/86 • Number of events 2 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
0.00%
0/87 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Renal and urinary disorders
Renal failure
|
1.2%
1/86 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/86 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
1.1%
1/87 • Number of events 1 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
Other adverse events
| Measure |
A: Erlotinib Group
n=86 participants at risk
Erlotinib (Tarceva)150 mg /day
Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.
For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
|
B: Standard Chemotherapy Group
n=87 participants at risk
4 cycles of Chemotherapy:
Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.
3 week cycles of standard intravenous chemotherapy
* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or
* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8
Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:
* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or
* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8
Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
|
|---|---|---|
|
General disorders
Fatigue
|
55.8%
48/86 • Number of events 48 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
64.4%
56/87 • Number of events 56 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
76.7%
66/86 • Number of events 66 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
4.6%
4/87 • Number of events 4 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Anaemia
|
11.6%
10/86 • Number of events 10 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
46.0%
40/87 • Number of events 40 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.0%
12/86 • Number of events 12 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
17.2%
15/87 • Number of events 15 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Blood and lymphatic system disorders
Aminotransferase rise
|
5.8%
5/86 • Number of events 5 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
5.7%
5/87 • Number of events 5 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
|
Nervous system disorders
Neuropathy
|
9.3%
8/86 • Number of events 8 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
13.8%
12/87 • Number of events 12 • 36 months
The severity of AE will be determined using CTCAE version 3.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place