Trial Outcomes & Findings for Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2 (NCT NCT00085839)
NCT ID: NCT00085839
Last Updated: 2012-08-09
Results Overview
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Until time of disease progression (maximum 5 months)
Results posted on
2012-08-09
Participant Flow
The first patient was treated 17 March 2004 and the last patient completed 19 March 2007.
Participant milestones
| Measure |
Erlotinib
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
|
Overall Study
COMPLETED
|
52
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Baseline characteristics by cohort
| Measure |
Erlotinib
n=52 Participants
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
n=51 Participants
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69 years
n=5 Participants
|
67 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 participants
n=5 Participants
|
33 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until time of disease progression (maximum 5 months)Population: All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Outcome measures
| Measure |
Erlotinib
n=52 Participants
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
n=51 Participants
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Progression-free Survival
|
1.91 months
Interval 1.28 to 2.69
|
3.52 months
Interval 1.48 to 4.73
|
SECONDARY outcome
Timeframe: From first study treatment until time of death (maximum 26.8 months)Population: All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.
Median number of months from first study treatment until time of death
Outcome measures
| Measure |
Erlotinib
n=52 Participants
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
n=51 Participants
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Overall Survival
|
6.57 months
Interval 3.78 to 8.25
|
9.53 months
Interval 7.46 to 15.54
|
SECONDARY outcome
Timeframe: While receiving study treatment (maximum 60 weeks)Population: All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.
Outcome measures
| Measure |
Erlotinib
n=52 Participants
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
n=51 Participants
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Best Tumor Response
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Best Tumor Response
Partial Response (PR)
|
2 participants
|
6 participants
|
|
Best Tumor Response
Stable Disease (SD)
|
19 participants
|
23 participants
|
|
Best Tumor Response
Progressive Disease (PD)
|
23 participants
|
10 participants
|
|
Best Tumor Response
Unable to Determine/Not Evaluable
|
8 participants
|
12 participants
|
Adverse Events
Erlotinib
Serious events: 24 serious events
Other events: 51 other events
Deaths: 0 deaths
Standard Chemotherapy
Serious events: 13 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib
n=52 participants at risk
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
n=51 participants at risk
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Endocarditis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia haemophilus
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Viral diarrhoea
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac fibrillation
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac tamponade
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Vascular disorders
Ischaemic limb pain
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Vascular disorders
Vena cava thrombosis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Vascular disorders
Hypotention
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Eye disorders
Optic neuritis
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
General disorders
Death
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Erlotinib
n=52 participants at risk
Erlotinib 150 mg/day continuous therapy
|
Standard Chemotherapy
n=51 participants at risk
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.6%
18/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
52.9%
27/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.2%
24/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
29.4%
15/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
12/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
29.4%
15/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
21.2%
11/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
27.5%
14/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
6/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
6/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
9.8%
5/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysgeusia
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.5%
6/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
51.0%
26/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.0%
13/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
12/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.3%
9/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
15.4%
8/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.6%
5/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
0.00%
0/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
36.5%
19/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
45.1%
23/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
15.7%
8/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
17.3%
9/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
9.6%
5/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
9.8%
5/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
11.8%
6/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
15.7%
8/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
13.7%
7/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.6%
18/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
31.4%
16/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
10/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
23.5%
12/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
6/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.5%
7/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
25.5%
13/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
19.6%
10/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
9.8%
5/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
23.1%
12/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
11.8%
6/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
13.7%
7/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.6%
5/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
19.6%
10/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
7.8%
4/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Eye disorders
Keratoconjunctivitis sicca
|
3.8%
2/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
3.9%
2/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
5.8%
3/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
4/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
2.0%
1/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
5.9%
3/51 • While on study drug and 30 days after last dose
Adverse events are provided regardless of causality; safety population includes patients who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60